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    Other relevant studies

    Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.

    Due to the large body of available evidence, studies with fewer than 50 patients have not been included in the appendix.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Amato A, Sinagra E, Celsa C et al. (2021). Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis. Endoscopy 53(10): 1037–47.

    Systematic review and meta-analysis

    n=820 EUS-CDS

    This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation.

    Larger systematic review (Dhindsa 2020) already included.

    Bang JY, Navaneethan U, Hasan M et al. (2018). Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomised trial (with videos). Gastrointestinal Endoscopy 88(1):18-20

    RCT

    n=67 (33 EUS-BD versus 34 ERCP)

    Follow up = until death or minimum 6 months (median 190 days)

    Given the similar rates of adverse events and treatment outcomes in this randomised trial, EUS-BD is a practical alternative to ERCP for primary biliary decompression in pancreatic cancer.

    Studies with more people or longer follow-up are included.

    Baniya R, Upadhaya S, Madala S et al. (2017). Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage after failed endoscopic retrograde cholangiopancreatography: a meta-analysis. Clinical and Experimental Gastroenterology 10: 67–74.

    Systematic review and meta-analysis

    n=312 (6 studies; 161 EBGD versus 151 PTBD)

    Technical (odds ratio (OR): 0.34; confidence interval (CI) 0.10–1.14; p=0.05) and clinical (OR: 1.48; CI 0.46–4.79; p=0.51) success rates were not statistically significant between the EGBD and PTBD groups. Mild adverse events were not significantly different (OR: 0.36; CI 0.10–1.24; p=0.11) but not the moderate-to-severe adverse events (OR: 0.16; CI 0.08–0.32; p≤0.00001) and total adverse events (OR: 0.34; CI 0.20–0.59; p≤0.0001). EGBD is equally effective but safer than PTBD.

    Larger systematic review already included.

    Bapaye A, Dubale N, Aher A. (2013). Comparison of endosonography-guided vs. percutaneous biliary stenting when papilla is inaccessible for ERCP. United European Gastroenterology Journal 1(4): 285–93.

    Non-randomised comparative study

    n=50 (25 EUS-BD versus 25 PTBD)

    In this retrospective study comparing success and complications of EUS-BD and PTBD in patients with inoperable malignant biliary obstruction and inaccessible papilla, EUS-BD was found superior to PTBD for both comparators.

    Studies with more people or longer follow-up are included.

    de Benito Sanz M, Nájera-Muñoz R, de la Serna-Higuera C et al. (2021). Lumen apposing metal stents versus tubular self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy in malignant biliary obstruction. Surgical Endoscopy 35(12): 6754–62.

    Non-randomised comparative study

    n=57 (37 lumen-apposing metal stents versus 20 self-expandable metal stents)

    Follow up: mean 376 ±145 days

    EUS-guided choledochoduodenostomy after failed ERCP has equally high technical and clinical success rates with either LAMS or SEMS in patients with malignant biliary obstruction. No differences in adverse events, reinterventions and survival were seen with either type of stent.

    Studies with more people or longer follow-up are included.

    Bill JG, Darcy M, Fujii-Lau LL et al. (2016). A comparison between endoscopic ultrasound-guided rendezvous and percutaneous biliary drainage after failed ERCP for malignant distal biliary obstruction. Endoscopy International Open 4(9): e980–5.

    Non-randomised comparative study

    n=50 (25 rendezvous EUS-BD versus 25 PTBD)

    Follow up: median 37 days for EUS-BD, median 11 days PTBD

    Initial technical success with EUSr was significantly lower than with PBD, however when EUSr was successful, patients had a significantly shorter post-procedure hospital stay and required fewer follow-up biliary interventions.

    Studies with more people or longer follow-up are included.

    Bill JG, Ryou M, Hathorn KE et al. (2022). Endoscopic ultrasound-guided biliary drainage in benign biliary pathology with normal foregut anatomy: a multicentre study. Surgical Endoscopy 36(2): 1362–8.

    Non-randomised comparative study

    n=86 (36 rendezvous EUS-BD versus 50 ERCP)

    Follow up: not reported

    EUS-BD remains a viable therapeutic option in the setting of benign biliary disease, with success rates of 77.8%. Adverse events were significantly more common with EUS-BD versus repeat ERCP, emphasising the need to perform in expert centres with appropriate multidisciplinary support and to strongly consider the urgency of biliary decompression before considering same session EUS-BD after failed initial biliary access.

    Studies with more people or longer follow-up are included.

    Bishay K, Boyne D, Yaghoobi M et al. (2019). Endoscopic ultrasound-guided transmural approach versus ERCP-guided transpapillary approach for primary decompression of malignant biliary obstruction: a meta-analysis. Endoscopy 51(10): 950-60.

    Meta-analysis

    n=396 (5 studies; 147 EUS-BD versus 249 ERCP)

    Follow up: median 95-298 days

    EUS-BD had similar clinical success rates and occlusion rates to ERCP in the primary decompression of malignant biliary obstruction from meta-analysis including a modest number of patients. EUS-BD may be a practical alternative to the ERCP-guided approach in such patients, but further well-designed prospective studies with larger numbers of patients are required to more clearly delineate potential differences in adverse events and cost.

    Larger meta-analysis already included.

    Boonmee C, Summart U, Tantraworasin A et al. (2021). Mortality rates of EUS-guided biliary drainage (EUS-BD) in malignant biliary obstruction patients in EUS-BD era versus non-EUS-BD era: A retrospective cohort study. Journal of Clinical and Diagnostic Research 15(3): 4–7.

    Non-randomised comparative study

    n=124 (30 EUS-BD versus 94 ERCP)

    Follow up: median 7.12 months EUS-BD, median 2.43 months non EUS-BD

    From present study it can be concluded that EUS-BD in MBO patients achieves lower mortality rate at one year follow-up. For conclusive findings of the benefit of EUS-BD, a prospective long-term study with larger numbers of subjects should be performed.

    Studies with more people or longer follow-up are included.

    Chin JY-L, Seleq S, Weilert F. (2020). Safety and outcomes of endoscopic ultrasound-guided drainage for malignant biliary obstruction using cautery-enabled lumen-apposing metal stent. Endoscopy International Open 8(11): e1633–8.

    Case series

    n=60 (56 EUS-CDS, 4 gallbladder drainage)

    Follow up: mean 7.9 months

    EUS-CDS and GBD using ECE-LAMS are effective EUS-based techniques for managing patients with MBO. AEs are usually mild and resolved by reintervention.

    Mixed interventions for which results are not reported separately.

    Cho DH, Lee SS, Oh D et al. (2017). Long-term outcomes of a newly developed hybrid metal stent for EUS-guided biliary drainage (with videos). Gastrointestinal Endoscopy 85(5): 1067–75.

    Case series

    n=54 (21 EUS-HGS and 33 EUS-CDS)

    Follow up: median 148.5 days

    EUS-BD with the hybrid metal stent is technically feasible and can effectively treat biliary obstruction after failed ERCP. EUS-BD with the hybrid metal stent can reduce stent-related adverse events, especially stent migration.

    Studies with more people or longer follow-up are included.

    Dhir V, Artifon EL, Gupta K et al. (2014). Multicentre study on endoscopic ultrasound-guided expandable biliary metal stent placement: choice of access route, direction of stent insertion, and drainage route. Digestive Endoscopy : Official Journal of the Japan Gastroenterological Endoscopy Society 26(3): 430–5.

    Non-randomised comparative study

    n=68 (34 transhepatic EUS-BD versus 31 transduodenal EUS-BD)
    Follow-up = minimum 3 months

    EUS-BD can be carried out with high success rates regardless of the choice of access route, stent direction or drainage route. However, complications are significantly higher with transhepatic access. The transduodenal route should be chosen for EUS-guided and rendezvous stent placements, when both routes are available.

    Studies with more people or longer follow-up are included.

    Dhir V, Bhandari S, Bapat M et al. (2012). Comparison of EUS-guided rendezvous and precut papillotomy techniques for biliary access (with videos). Gastrointestinal Endoscopy, Comment in: Gastrointest Endosc. 2012 Feb;75(2):360-1 PMID:

    Non-randomised comparative study

    n=202 (58 EUS-BD versus 144 precut papillotomy)

    Follow-up = minimum 3 months

    In this study, the EUS-guided rendezvous technique was found to be superior to precut
    papillotomy for single-session biliary access. Prospective randomised trials are needed to confirm these preliminary but promising findings.

    More recent studies included.

    Study included in Dhindsa (2020) systematic review.

    El Chafic AH, Shah JN, Hamerski C et al. (2019). EUS-guided choledochoduodenostomy for distal malignant biliary obstruction using electrocautery-enhanced lumen-apposing metal stents: first US, multicentre experience. Digestive Diseases and Sciences 64(11): 3321–7.

    Case series

    n=57 EUS-CDS

    EUS-CD using LAMS with cautery-enhanced delivery systems has high technical and clinical success rates,
    with a low rate of adverse events. Inserting an axis-orienting stent through the lumen of the LAMS may reduce the need for
    biliary re-interventions

    Studies with more people or longer follow-up are included.

    Fabbri C, Luigiano C, Lisotti A et al. (2014). Endoscopic ultrasound-guided treatments: Are we getting evidence based - a systematic review. World Journal of Gastroenterology 20(26): 8424–48.

    Systematic review
    n=312 studies

    Several EUS-guided treatments are now available in the endosonographer's armamentarium. The usefulness of EUS-GD of PFCs and of EUS-CPN has been well established in studies with high LE. Other techniques including EUS-guided biliary drainage have been tested only in studies with medium-low LE and thus should still be performed either in referral centres by experienced endosonographers or in investigational/research settings. Well-designed RCTs are warranted to further elucidate the safety and benefits of EUS-guided treatments in comparison to the standards of care.

    Mixed interventions.

    No meta-analysis.

    Fábián A, Bor R, Gede N et al. (2020). Double stenting for malignant biliary and duodenal obstruction: a Systematic review and meta-analysis. Clinical and Translational Gastroenterology 11(4): e00161.

    Systematic review

    n=80 studies

    Substantially high technical and clinical success can be achieved with double stenting. Based on the adverse event profile, ERCP can be recommended as the first choice for biliary stenting as part of double stenting, if feasible. Prospective comparative studies with well-defined outcomes and cohorts are needed.

    Study focuses on stenting technique.

    Mixed indications.

    Facciorusso A, Mangiavillano B, Paduano D et al. (2022). Methods for Drainage of Distal Malignant Biliary Obstruction after ERCP Failure: A Systematic Review and Network Meta-Analysis. Cancers 14(13): 3291.

    Systematic review and network meta-analysis

    n=217 (5 studies; 84 EUS-CDS versus 73 EUS-HGS versus 44 PBTD versus 16 surgical hepaticojejunostomy)

    In conclusion, all interventions seem to be effective for the drainage of DMBO, although PTBD showed a trend towards higher rates of adverse events

    Larger systematic review (Dhindsa 2020) already included.

    Ginestet C, Sanglier F, Hummel V et al. (2022). EUS-guided biliary drainage with electrocautery-enhanced lumen-apposing metal stent placement should replace PTBD after ERCP failure in patients with distal tumoural biliary obstruction: a large real-life study. Surgical Endoscopy 36(5): 3365–73.

    Non-randomised comparative study

    n=95 (50 EUS-BD versus 45 PTBD)

    Follow up = 1 month

    Our results are in favour of EUS-BD using electrocautery-enhanced lumen-apposing metal stent in case of ERCP failure for a distal tumour biliary obstruction. Operators performing ERCP for distal tumour biliary obstruction must learn this backup procedure because of its superiority over percutaneous transhepatic biliary drainage in terms of clinical success, safety, cost, and overall survival.

    Studies with more people or longer follow-up are included.

    Gupta K, Perez-Miranda M, Kahaleh M et al. (2014). Endoscopic ultrasound-assisted bile duct access and drainage: multicentre, long-term analysis of approach, outcomes, and complications of a technique in evolution. Journal of Clinical Gastroenterology 48(1): 80–7.

    Case series

    n=240

    Follow up = not reported

    The EUS-BD technique is currently limited by a lack of dedicated devices and large data reporting outcomes and complications. Larger prospective and multicentre studies are needed to better define the indications, outcomes, and complications. With greater experience and dedicated devices, EUS-BD can be an effective alternative.

    More recent studies included.

    Study included in Dhindsa (2020) systematic review.

    Hamada T, Nakai Y, Lau JY et al. (2018). International study of endoscopic management of distal malignant biliary obstruction combined with duodenal obstruction. Scandinavian Journal of Gastroenterology 53(1): 46–55.

    Non-randomised comparative study

    n=110 (10 EUS-CDS versus 10 EUS-HGS versus 90 ERCP)

    Follow up = until death (median survival 199 days)

    Transpapillary or transmural endoscopic biliary drainage with a duodenal stent was effective, irrespective of the timing or location of duodenal obstruction. A prospective study is required considering the tradeoff of technical success rate, stent patency, and adverse events.

    Studies with more people or longer follow-up are included.

    Han SY, Kim S-O, So H et al. (2019). EUS-guided biliary drainage versus ERCP for first-line palliation of malignant distal biliary obstruction: A systematic review and meta-analysis. Scientific Reports 9(1): 1-9.

    Systematic review and meta-analysis

    n=756 (10 studies, 331 EUS-BD versus 425 ERCP)

    As first-line palliation of MDBO, EUS-BD was similar to ERCP in technical and clinical success and safety; however, larger randomised trials comparing EUS-CDS and ERCP in this setting with endoscopically accessible papilla may be required.

    Larger systematic review (Dhindsa 2020) already included.

    Hao F, Zheng M, Qin M. (2014). The effect of endoscopic ultrasonography in treatment of distal inflammatory biliary stricture: a retrospective analysis of 165 cases. Hepato-Gastroenterology 61(136): 2177–80.

    Case series

    n=165

    Follow up = mean 27.6 months

    EUS for distal inflammatory biliary stricture can be selected as a safe, effective and minimally invasive therapeutic method.

    Studies with more people or longer follow-up are included.

    Hathorn KE, Bazarbashi AN, Sack JS et al. (2019). EUS-guided biliary drainage is equivalent to ERCP for primary treatment of malignant distal biliary obstruction: A systematic review and meta-analysis. Endoscopy International Open 7(11): e1432–41.

    Systematic review and meta-analysis

    n=318 (7 studies, 193 EUS-BD versus 159 ERCP)

    Primary EUS-BD is an effective treatment with few AE. Comparing EUS-BD versus ERCP, EUS-BD has comparable efficacy and improved safety as a primary treatment for malignant biliary obstruction. Further randomised trials should be performed to identify patient populations and clinical scenarios in which primary EUS-BD would be most appropriate.

    Larger systematic review (Dhindsa 2020) already included.

    Hayat U, Bakker C, DIrweesh A et al. (2022). EUS-guided versus percutaneous transhepatic cholangiography biliary drainage for obstructed distal malignant biliary strictures in patients who have failed endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis. Endoscopic Ultrasound 11(1): 4–16.

    Systematic review and meta-analysis

    n=1131 (567 EUS‑BD versus 564 patients PTC)

    This meta‑analysis indicates that endoscopic biliary
    drainage (EUS‑BD) is equally effective but safer in terms of acute and total adverse events than percutaneous transhepatic biliary
    drainage (PTC) for biliary decompression in patients with malignant biliary strictures who have failed an ERCP.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Huang P, Zhang H, Zhang X-F et al. (2017). Comparison of endoscopic ultrasonography guided biliary drainage and percutaneous transhepatic biliary drainage in the management of malignant obstructive jaundice after failed ERCP. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 27(6):127-31.

    Non-randomised comparative study

    n=66 (36 EUS-BD versus 30 PTBD)

    Follow up = 1 month

    In the treatment of malignant obstructive jaundice, endoscopic ultrasonography guided biliary drainage is safer and more effective than percutaneous transhepatic biliary drainage when performed by experienced practitioners after failed ERCP. Its more widespread use is recommended.

    Studies with more people or longer follow-up are included.

    Huang P, Zhang H, Zhang X-F et al. (2020). Application and value of endoscopic ultrasonography guided biliary interventional therapy in patients with biliary obstruction and surgically altered anatomy. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 30(5): 454–8.

    Non-randomised comparative study

    n=60 (33 EUS-BD versus 27 PTBD)

    Follow up = up to 6 months

    EUS-BD may be the first choice for patients with biliary obstruction and surgically altered anatomy after a failed endoscopic retrograde cholangiography in centres with expertise in EUS-BD procedures.

    Studies with more people or longer follow-up are included.

    Imai H, Takenaka M, Omoto S et al. (2017). Utility of Imai H, Takenaka M, Omoto S et al. (2017). Utility of of endoscopic ultrasound-guided hepaticogastrostomy with antegrade stenting for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Oncology 93(Suppl. 1): 69–75.

    Non-randomised comparative study

    n=79 (42 EUS-HGS versus 37 EUS-HGS+AGS)

    Follow up = not reported

    Although the technical success rate of HGS with AGS was lower than that of HGS, HGS with AGS was superior to HGS in terms of adverse event rate and stent patency in patients receiving chemotherapy.

    Studies with more people or longer follow-up are included.

    Ishiwatari H, Ishikawa K, Niiya F et al. (2022). Endoscopic ultrasound-guided hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting for malignant distal biliary obstruction. Journal of Hepato-Biliary-Pancreatic Sciences 29: 703-12.

    Non-randomised comparative study

    n=96 (58 EUS-HGS versus 38 EUS-HGS+AGS)

    Follow up = not reported

    Endoscopic ultrasound-guided hepaticogastrostomy with AGS prolonged the time to recurrent biliary obstruction compared with EUS-HGS alone for biliary drainage in patients with MDBO.

    Studies with more people or longer follow-up are included.

    Ishiwatari H, Satoh T, Sato J et al. (2021). Bile aspiration during EUS-guided hepaticogastrostomy is associated with lower risk of postprocedural adverse events: a retrospective single-centre study. Surgical Endoscopy 35(12): 6836–45.

    Non-randomised comparative study

    n=96 (45 EUS-HGS versus 51 EUS-HGS+AGS)

    Follow up = not reported

    Bile aspiration of more than 10 mL during EUS-HGS contributes to reducing the rate of postprocedural AE

    Study focuses on procedural technique.

    Iwashita T, Uemura S, Mita N et al. (2020). Endoscopic ultrasound guided-antegrade biliary stenting vs percutaneous transhepatic biliary stenting for unresectable distal malignant biliary obstruction in patients with surgically altered anatomy. Journal of Hepato-Biliary-Pancreatic Sciences 27(12): 968–76.

    Non-randomised comparative study

    n=64 (45 EUS-AGS versus 29 PTBD)

    Follow up = not reported

    Similar to PTBD, EUS-ABS can effectively and safely manage DMBO in patients with surgically altered anatomy. Further well-designed trials are warranted to confirm these findings.

    Studies with more people or longer follow-up are included.

    Jacques J, Privat J, Pinard F et al. (2019). Endoscopic ultrasound-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing stents: a retrospective analysis. Endoscopy 51(6): 540–7.

    Case series

    n=52 EUS-CDS

    Follow up = mean 157 days

    EUS-CDS with an ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct and could be proposed as the first option in cases of ERCP failure.

    Studies with more people or longer follow-up are included.

    Jacques J, Privat J, Pinard F et al. (2020). EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicentre study after implementation of the technique (with video). Gastrointestinal Endoscopy 92(1): 134–41.

    Case series

    n=70 EUS-CDS

    Follow up = mean 153 days

    EUS-CDS with the ECE-LAMS is efficacious and safe in distal malignant obstruction of the common bile duct in cases of ERCP failure with impressive results once expertise is acquired and the recommended technique (direct fistulotomy, pure cut current, and 6-mm stent) is followed

    Studies with more people or longer follow-up are included.

    Jagielski M, Zielinski M, Piatkowski J et al. (2021). Outcomes and limitations of endoscopic ultrasound-guided hepaticogastrostomy in malignant biliary obstruction. BMC Gastroenterology 21(1): 202.

    Case series

    n=53 EUS-HGS

    Follow up = mean 155 days

    In the event of transpapillary biliary drainage proving inefective, extra-anatomical anastomoses of intrahepatic bile ducts to the gastrointestinal tract provide an effective method for the treatment of patients with malignant biliary obstruction.

    Studies with more people or longer follow-up are included.

    Jagielski M, Zielinski M, Piatkowski J et al. (2022). The Role of Endoscopic Ultrasound-guided Transmural Approach in the Management of Biliary Obstructions. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 32(3): 285–91.

    Case series

    n=124 EUS-BD

    Follow up = average 9 months

    Various methods of EUS-guided transmural access to bile ducts improves endotherapy outcomes of patients with biliary obstruction. Endoscopic transmural access is highly effective and associated with an acceptable number of complications.

    Studies with more people or longer follow-up are included.

    Jiang XW, Tang SH, Yang JQ et al. (2014). Ultrasound-guided endoscopic biliary drainage: a useful drainage method for biliary decompression in patients with biliary obstructions. Digestive Diseases and Sciences 59(1): 161–67.

    Non-randomised comparative study

    n=125 (63 ultrasound-guided endoscopic biliary versus 62 fluoroscopy-guided endoscopic biliary drainage)

    Follow up = not reported

    Endoscopic biliary drainage (EBD) under US-guidance and under fluoroscopy guidance is equally effective and safe for patients with lower or upper/middle
    obstructions of the CBD. The UG-EBD technique is especially suitable for special patients, such as critically ill patients, pregnant woman, etc.

    Studies with more people or longer follow-up are included.

    Jin Z, Wei Y, Lin H et al. (2020). Endoscopic ultrasound-guided versus endoscopic retrograde cholangiopancreatography-guided biliary drainage for primary treatment of distal malignant biliary obstruction: A systematic review and meta-analysis. Digestive Endoscopy : Official Journal of the Japan Gastroenterological Endoscopy Society 32(1): 16–26.

    Systematic review and meta-analysis

    n=361 (171 EUS-BD versus 190 ERCP), 5 studies

    Follow up = median 95 to 298 days

    With adequate endoscopy expertise, EUS-BD could show similar efficacy and safety when compared with ERCP-BD for primary palliation of distal MBO and exhibits several clinical advantages.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Kakked G, Salameh H, Cheesman A et al. (2020). Primary EUS-guided biliary drainage versus ERCP drainage for the management of malignant biliary obstruction: A systematic review and meta-analysis. Endoscopic Ultrasound 9(5): 298–307.

    Systematic review and meta-analysis

    n=302 (137 EUS-BD versus 165 ERCP), 4 studies

    Follow up = median 95 to 298 days

    EUS‑BD has comparable technical and clinical success to ERCP and can potentially be used as a first‑line palliative modality for MBO where expertise is
    available. ERCP‑related pancreatitis which can cause significant morbidity can be completely avoided with EUS.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Kanno Y, Koshita S, Ogawa T et al. (2019). EUS-Guided Biliary Drainage for Unresectable Malignant Biliary Obstruction: 10-Year Experience of 99 Cases at a Single Centre. Journal of Gastrointestinal Cancer 50(3): 469–77.

    Case series

    n=99 EUS-BD

    Follow up = mean 136 days

    EUS-BD was found to be feasible. However, there were a few patients with an unfavourable course after successful EUS-BD.

    Studies with more people or longer follow-up are included.

    Kawakubo K, Isayama H, Kato H et al. (2014). Multicentre retrospective study of endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction in Japan. Journal of Hepato-Biliary-Pancreatic Sciences 21(5): 328–34.

    Case series

    n=64 EUS-BD

    Follow up = mean 136 days

    This Japanese multicentre study revealed a high success rate in EUS-BD. However, the complication rate was as high as that in previous series. Covered metal stents may be useful to reduce bile leakage in EUS-BD.

    Studies with more people or longer follow-up are included.

    Kawakubo K, Kawakami H, Kuwatani M et al. (2016). Endoscopic ultrasound-guided choledochoduodenostomy vs. transpapillary stenting for distal biliary obstruction. Endoscopy 48(2): 164–9.

    Case series

    n=82 (26 EUS-CDS versus 56 endoscopic transpapillary stenting)

    Follow up = mean 136 days

    EUS-CDS performed by expert endoscopists was associated with a short procedure time and no risk of pancreatitis, and would therefore be feasible as a first-line treatment for patients with distal malignant biliary obstruction.

    Studies with more people or longer follow-up are included.

    Khan MA, Akbar A, Baron TH et al. (2016). Endoscopic Ultrasound-Guided Biliary Drainage: A Systematic Review and Meta-Analysis. Digestive Diseases and Sciences 61(3): 684–703.

    Systematic review and meta-analysis

    n=1186, 20 studies

    In cases of failure of traditional ERC to achieve biliary drainage, EUS-BD appears to be an emerging therapeutic modality with a cumulative success
    rate of 90 % and cumulative adverse events rate of 17 %. Randomised controlled trials are required to further evaluate the efficacy and safety of the procedure along with the comparison to traditional modalities like percutaneous transhepatic biliary drainage.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Khashab M, Messallam A, Penas I et al. (2016). International multicentre comparative trial of transluminal EUS-guided biliary drainage via hepatogastrostomy vs. choledochoduodenostomy approaches. Endoscopy International Open 4(2): e175–81.

    Non-randomised comparative study

    n=121 (60 EUS-CDS versus 61 EUS-HGS)

    Follow up = mean 151 days

    Both EUS-CDS and EUS-HG are effective and safe techniques for the treatment of distal biliary obstruction after failed ERCP. However, CDS is associated with shorter hospital stay, improved stent patency, and fewer procedure- and stent-related complications. Metallic stents should be placed whenever feasible and non-coaxial electrocautery should be avoided when possible as plastic stenting and non-coaxial electrocautery were independently associated with occurrence of adverse events.

    Studies with more people or longer follow-up are included.

    Khashab MA, El Zein MH, Sharzehi K et al. (2016). EUS-guided biliary drainage or enteroscopy-assisted ERCP in patients with surgical anatomy and biliary obstruction: An international comparative study. Endoscopy International Open 4(12): e1322–7.

    Non-randomised comparative study

    n=98 (49 EUS-BD versus 49 ERCP)

    Follow up = not reported

    EUS-BD can be performed with a higher degree of clinical efficacy and shorter procedure time than e-ERCP in patients with surgically-altered upper gastrointestinal anatomy. Whether or not this approach should be first-line therapy in this patient population is highly dependent on the indication for the procedure, the patient's anatomy, and local practice and expertise.

    Studies with more people or longer follow-up are included.

    Khashab MA, Valeshabad AK, Afghani E et al. (2015). A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Digestive Diseases and Sciences 60(2): 557–65.

    Non-randomised comparative study

    n=73 (22 EUS-BD versus 51 PTBD)

    Follow up = not reported

    EGBD and PTBD are comparably effective techniques for treatment of distal malignant biliary obstruction after failed ERCP. However, EGBD is associated with decreased adverse events rate and is significantly less costly due to the need for fewer reinterventions. Our results suggest that EGBD should be the technique of choice for treatment of these patients at institutions with experienced interventional endosonographers.

    Studies with more people or longer follow-up are included.

    Khashab MA, Van Der Merwe S, Kunda R et al. (2016). Prospective international multicentre study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endoscopy International Open 4(4): e487–96.

    Non-randomised comparative study

    n=98 (49 EUS-BD versus 49 ERCP)

    Follow up = median 94 days

    This study on EUS-BD demonstrates excellent efficacy and safety of EUS-BD when performed by experts.

    Studies with more people or longer follow-up are included.

    Krishnamoorthi R, Dasari CS, Thoguluva Chandrasekar V et al. (2020). Effectiveness and safety of EUS-guided choledochoduodenostomy using lumen-apposing metal stents (LAMS): a systematic review and meta-analysis. Surgical Endoscopy 34(7): 2866–77.

    Systematic review and meta-analysis

    n=284, 7 studies

    CDD using LAMS/EC-LAMS is an effective and safe technique for biliary decompression in patients who failed ERCP. Further studies are needed to assess CDD using LAMS as primary treatment modality for biliary obstruction.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Kunda R, Perez-Miranda M, Will U et al. (2016). EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP. Surgical Endoscopy 30(11): 5002–8.

    Case series

    n=57 EUS-CDS

    Follow up = mean 151 days

    Our study shows that EUS-CD using the AXIOS and the Hot AXIOS devices is a safe procedure, with high technical and clinical success rates.

    Studies with more people or longer follow-up are included.

    Kuraoka N, Hara K, Okuno N et al. (2020). Outcomes of EUS-guided choledochoduodenostomy as primary drainage for distal biliary obstruction with covered self-expandable metallic stents. Endoscopy International Open 8(7): e861–68.

    Case series

    n=92 EUS-CDS

    Follow up = not reported

    EUS-CDS as a primary drainage technique using SEMS has high technical and clinical success rates. It should be considered an effective drainage method with respect to long-term stent patency, low re-intervention rates, and absence of severe complications.

    Studies with more people or longer follow-up are included.

    Lee TH, Choi J-H, Park DH et al. (2016). Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 14(7): 1011-9.

    RCT

    n=66 (34 EUS-BD versus 32 PTBD)

    Follow up = minimum 3 months

    EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions.

    Studies with more people or longer follow-up are included.

    Li D-F, Zhou C-H, Wang L-S et al. (2019). Is ERCP-BD or EUS-BD the preferred decompression modality for malignant distal biliary obstruction? A meta-analysis of randomised controlled trials. Revista Espanola de Enfermedades Digestivas : Organo Oficial de La Sociedad Espanola de Patologia Digestiva 111(12): 953–60.

    Meta-analysis

    n=220, 3 studies

    Technical success, treatment success, procedure duration, and overall adverse event rate were comparable between ERCP-BD and EUS-BD in decompressing
    malignant distal biliary obstruction. Nevertheless, EUS-BD had a significantly lower rate of PEP and a lower tendency toward stent reintervention than ERCP-BD. Therefore, EUS-BD might be a suitable alternative to ERCP-BD when performed by experts.

    Larger meta-analysis (Dhindsa 2020) already included.

    Lou X, Yu D, Li J et al. (2019). Efficacy of endoscopic ultrasound-guided and endoscopic retrograde cholangiopancreatography-guided biliary drainage for malignant biliary obstruction: a systematic review and meta-analysis. Minerva Medica 110(6): 564–74.

    Systematic review and meta-analysis

    n=428, 4 studies

    EUS-BD and ERCP-BD in terms of relief of malignant biliary obstruction presented the similarity rate of technical success, clinical success and there is no significant difference in adverse events of two procedures. EUS-BD could be used as a substitute for ERCP-BD, even considered as first-line treatment.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Lyu Y, Li T, Cheng Y et al. (2021). Endoscopic ultrasound-guided vs ERCP-guided biliary drainage for malignant biliary obstruction: A up-to-date meta-analysis and systematic review. Digestive and Liver Disease: Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 53(10): 1247–53.

    Systematic review and meta-analysis

    n=634, 9 studies

    EUS-BD was associated with lower reintervention rates compared with ERCP-BD, with comparable safety and efficacy outcomes. However, more high-quality randomised trials are required.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Mao K, Hu B, Sun F et al. (2021). Choledochoduodenostomy Versus Hepaticogastrostomy in Endoscopic Ultrasound-guided Drainage for Malignant Biliary Obstruction: A Meta-analysis and Systematic Review. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 32(1): 124–32.

    Systematic review and meta-analysis

    n=222 (359 EUS-CDS versus 400 EUS-HGS), 9 studies

    EUS-CDS and EUS-HGS have comparable technical and clinical success rates, adverse events, and overall survival. However, EUS-CDS has less reintervention and stent obstruction.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Miller CS, Barkun AN, Martel M et al. (2019). Endoscopic ultrasound-guided biliary drainage for distal malignant obstruction: A systematic review and meta-analysis of randomised trials. Endoscopy International Open 7(11): e1563–73.

    Systematic review and meta-analysis

    n=354, 9 studies

    In a meta-analysis of randomised trials comparing EUS-BD to conventional biliary drainage modalities, no difference in technical or clinical success was observed. Importantly, EUS-BD was associated with decreased risks of stent/catheter dysfunction when compared to both PTBD and ERCP, and decreased post-procedure pancreatitis when compared to ERCP, suggesting the potential role for EUS-BD as an alternative first-line therapy in distal malignant biliary obstruction.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Moole H, Bechtold ML, Forcione D et al. (2017). A meta-analysis and systematic review: Success of endoscopic ultrasound guided biliary stenting in patients with inoperable malignant biliary strictures and a failed ERCP. Medicine 96(3): e5154.

    Systematic review and meta-analysis

    n=528, 16 studies

    In patients with inoperable malignant biliary strictures who failed an ERCP guided biliary stenting, EUS-BD seems to be an excellent management option with higher successful biliary drainage rates and relatively fewer complications. EUS-BD seems to be significantly superior to PTBD with higher successful drainage rates and fewer complications. In patients with failed ERCP and altered biliary and duodenal anatomy, EUS-BD should be preferred to PTBD when appropriate operator expertise and infrastructure is available.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Nakai Y, Sato T, Hakuta R et al. (2020). Long-term outcomes of a long, partially covered metal stent for EUS-guided hepaticogastrostomy in patients with malignant biliary obstruction (with video). Gastrointestinal Endoscopy 92(3): 623-31.

    Case series

    n=110 EUS-HGS

    Follow up = not reported

    EUS-HGS using an LP-CMS for unresectable MBO was safe and effective. RBO was not uncommon, but reintervention through the EUS-HGS route was technically possible in most cases.

    Studies with more people or longer follow-up are included.

    Park DH, Jang JW, Lee SS et al. (2011). EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results. Gastrointestinal Endoscopy 74(6): 1276–84.

    Case series

    n=57 EUS-BD

    Follow up = mean 205 days

    EUS-HGS and EUS-CDS may be relatively safe and can be used as an alternative to PTBD after failed ERCP. Both techniques offer durable and comparable stent patency. The use of a needle-knife for fistula dilation in EUS-BDS should be avoided if possible.

    Studies with more people or longer follow-up are included.

    Peng Z, Li S, Tang Y et al. (2021). Efficacy and safety of EUS-guided choledochoduodenostomy using electrocautery-enhanced lumen-apposing metal stents (ECE-LAMS) in the treatment of biliary obstruction: A systematic review and meta-analysis. Canadian Journal of Gastroenterology and Hepatology 2021: 6696950.

    Systematic review and meta-analysis

    n=270, 6 studies

    EUS-CDS using ECE-LAMS provides favourable outcomes in patients with biliary obstruction. It has been associated with a higher success rate and a lower rate of adverse events when compared with the biliary drainage approaches previously used. Large and randomised controlled observational studies are required to further refine the findings in the present analysis.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Poincloux L, Rouquette O, Buc E et al. (2015). Endoscopic ultrasound-guided biliary drainage after failed ERCP: cumulative experience of 101 procedures at a single centre. Endoscopy 47(9): 794–801.

    Case series

    n=101 EUS-BD

    Follow up = mean 280 days

    EUS-guided biliary drainage is an efficient technique, but is associated with significant morbidity that seems to decrease with the learning curve. It should be performed in tertiary care centres in selected patients. Prospective randomised studies are needed to compare EUS-guided biliary drainage with percutaneous transhepatic cholangiography drainage.

    Studies with more people or longer follow-up are included.

    Puga M, Pallares N, Velasquez-Rodriguez J et al. (2019). Endoscopic biliary drainage in unresectable biliary obstruction: the role of endoscopic ultrasound-guidance in a cohort study. Revista Espanola de Enfermedades Digestivas : Organo Oficial de La Sociedad Espanola de Patologia Digestiva 111(9): 683–9.

    Case series

    n=52 EUS-BD

    Follow up = minimum 1 year

    The requirement of EUS-BD in palliative biliopancreatic pathology is not marginal. EUS-BD is associated with a lower survival rate and a higher rate of fatal AE, which argues against its use as a first choice procedure.

    Studies with more people or longer follow-up are included.

    Sharaiha RZ, Khan MA, Kamal F et al. (2017). Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointestinal Endoscopy 85(5): 904–14.

    Systematic review and meta-analysis

    n=483 (252 EUS-BD versus 231 PTBD), 9 studies

    When ERCP fails to achieve biliary drainage, EUS-guided interventions may be preferred over PTBD if adequate advanced endoscopy expertise and logistics are available. EUS-BD is associated with significantly better clinical success, lower rate of postprocedure adverse events, and fewer reinterventions.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Sharaiha RZ, Kumta NA, Desai AP et al. (2016). Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography. Surgical Endoscopy 30(12): 5500–5.

    Case series

    n=60 (47 EUS-BD versus 13 PTBD)

    Follow up = not reported

    Despite similar technical success rates compared to PTBD, EUS-BD results in a lower need for reintervention, decreased rate of late adverse events, and lower pain scores, and is the sole predictor for clinical success and long-term resolution. EUS-BD should be the treatment of choice after a failed ERCP.

    Studies with more people or longer follow-up are included.

    Sportes A, Camus M, Greget M et al. (2017). Endoscopic ultrasound-guided hepaticogastrostomy versus percutaneous transhepatic drainage for malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography: A retrospective expertise-based study from two centres. Therapeutic Advances in Gastroenterology 10(6): 483–93.

    Case series

    n=51 (31 EUS-HGS versus 20 PTBD)

    Follow up = until death or transfer to palliative care centre

    EUS-HGS can be an effective and safe mini invasive-procedure alternative to PTBD, with similar success and adverse-event rates, but with lower rates of reintervention and length of hospitalisation

    Studies with more people or longer follow-up are included.

    Tellez-Avila FI, Figueredo-Zacarias MA, Munoz-Anaya E et al. (2021). EUS-guided biliary drainage in patients with distal malignant biliary obstruction requires fewer interventions and has a lower cost compared to ERCP biliary drainage. Surgical Endoscopy 35(6): 2531–36.

    Non-randomised comparative study

    n=124 (24 EUS-BD versus 60 ERCP with plastic stent-PS versus 40 ERCP with metal stent)

    Follow up = not reported

    EUS-BD requires fewer reinterventions and has a lower cost compared to drainage by ERCP with metal or
    plastic stents.

    Studies with more people or longer follow-up are included.

    Tellez-Avila FI, Herrera-Mora D, Duarte-Medrano G et al. (2018). Biliary Drainage in Patients With Failed ERCP: Percutaneous Versus EUS-guided Drainage. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 28(3): 183–87.

    Non-randomised comparative study

    n=62 (30 EUS-BD/EGBD versus 32 PTBD)

    Follow up = not reported

    EGBD is associated with a higher clinical success rate and safety, shorter hospital stays, and lower cost compared with PTBD.

    Studies with more people or longer follow-up are included.

    Teoh AYB, Kongkam P, Bapaye A et al. (2021). Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Digestive Endoscopy : Official Journal of the Japan Gastroenterological Endoscopy Society 33(7): 1139–45.

    Non-randomised comparative study

    n=53 (26 EUS-CDS versus 27 EUS-GBD)

    Follow up = mean 131 days

    The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term.

    Studies with more people or longer follow-up are included.

    Tyberg A, Desai AP, Kumta NA et al. (2016). EUS-guided biliary drainage after failed ERCP: a novel algorithm individualized based on patient anatomy. Gastrointestinal Endoscopy 84(6): 941–46.

    Case series

    n=52 EUS-BD

    Follow up = mean 12.5 weeks

    EUS-BD obstruction after failed conventional ERCP is successful and safe when this novel algorithm is used.

    Studies with more people or longer follow-up are included.

    Uemura RS, Khan MA, Otoch JP et al. (2018). EUS-guided Choledochoduodenostomy Versus Hepaticogastrostomy. Journal of Clinical Gastroenterology 52(2): 123–30.

    Systematic review and meta-analysis

    n=434 (208 EUS-HGS versus 226 EUS-CDS), 10 studies

    EUS-CDS and EUS-HGS have equal efficacy and safety, and are both associated with a very high technical and clinical success. The choice of approach may be selected based on patient anatomy.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Wang K, Zhu J, Xing L et al. (2016). Assessment of efficacy and safety of EUS-guided biliary drainage: a systematic review. Gastrointestinal Endoscopy 83(6): 1218–27.

    Systematic review and meta-analysis

    n=1192 (42 studies)

    Although it is associated with significant morbidity, EUS-BD is an effective alternative procedure for relieving biliary obstruction. There was no significant difference between the transduodenal and transgastric approaches for EUS-BD.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Wang Y, Lyu Y, Li T et al. (2021). Comparing Outcomes Following Endoscopic Ultrasound-Guided Biliary Drainage Versus Percutaneous Transhepatic Biliary Drainage for Malignant Biliary Obstruction: A Systematic Review and Meta-Analysis. Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A.

    Systematic review and meta-analysis

    n=512 (256 EUS-BD versus 256 percutaneous transhepatic biliary drainage), 9 studies

    The available literature suggests that EUS-BD is associated with fewer adverse events, greater clinical success, and comparable technical success compared with percutaneous transhepatic biliary drainage. According to the shortcomings of our study, more large, high-quality, randomised controlled trials are needed to compare these techniques and confirm our findings.

    Larger systematic review and meta-analysis (Dhindsa 2020) already included.

    Will U, Fueldner F, Kern C et al. (2015). EUS-Guided Bile Duct Drainage (EUBD) in 95 Patients. Ultraschall in Der Medizin (Stuttgart, Germany : 1980) 36(3): 276–83.

    Case series

    n=95 EUS-BD

    Follow up = mean 8 months

    EUS-BD is a promising therapy for bile duct obstruction in patients predominantly with malignant diseases. Using EUS-BD, an excellent interventional approach is available for long term internal drainage to prevent percutaneous drainage. EUS-guided drainage is challenging and needs extraordinary interventional expertise, preferentially in tertiary gastroenterological and endoscopic centres.

    Studies with more people or longer follow-up are included.

    Xie J, Garg S, Perisetti A et al. (2022). Comparison of Biliary Drainage Techniques for Malignant Biliary Obstruction: A Systematic Review and Network Meta-analysis. Journal of Clinical Gastroenterology 56(1): 88–97.

    Systematic review and network meta-analysis

    n=1566 (419 EUS-BD versus 478 ERCP versus 649 PTBD), 17 studies

    The available evidence did not favor any intervention for drainage of malignant biliary obstruction across all the outcomes assessed. ERCP with or without EUS should be considered first to allow simultaneous tissue acquisition and biliary drainage.

    Systematic review and meta-analysis with more EUS-BD patients (Dhindsa 2020) already included.

    Zhang HC, Tamil M, Kukreja K et al. (2020). Review of simultaneous double stenting using endoscopic ultrasound-guided biliary drainage techniques in combined gastric outlet and biliary obstructions. Clinical Endoscopy 53(2): 167–75.

    Non-randomised comparative study

    n=152 (24 PTBD versus 44 endoscopic plastic biliary stent (EPBS) versus 48 endoscopic metal biliary stent versus 36 EPBS+EMBS

    Follow up = not reported

    The EPBS+EMBS drainage method may improve the successful biliary drainage, have lower complications, longer patency, and longer survival time than other drainage methods.

    Study focuses on stenting technique.

    Zhao X, Shi L, Wang J et al. (2022). Clinical value of preferred endoscopic ultrasound-guided antegrade surgery in the treatment of extrahepatic bile duct malignant obstruction. Clinics (Sao Paulo, Brazil) 77: 100017.

    Case series

    n=58 EUS-AGS

    Follow up = not reported

    EUS-AG operation has short time, low incidence of complications, safe, effective, and can be used as the preferred treatment plan for patients with extrahepatic biliary duct malignant obstruction associated with intrahepatic biliary duct expansion; EUS-AG operation has more unique clinical advantages for patients with altered gastrointestinal anatomy or upper gastrointestinal obstruction.

    Studies with more people or longer follow-up are included.

    Zhou Z, Liu H, Xu X et al. (2016). Comparison of efficiency and prognostic analysis in four biliary drainages for treatment of malignant obstructive jaundice. International Journal of Clinical and Experimental Medicine 9(6): 11409–18.

    Systematic review
    n=51, 7 studies

    We conclude that simultaneous double stenting with EUS-BD and gastroduodenal stenting for GOBO is associated with high success rates. It is a feasible and practical alternative to percutaneous biliary drainage or surgery for palliation in patients with associated advanced malignancies.

    Studies with more people or longer follow-up are included.

    No meta-analysis