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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.

    Case series with 10 or fewer patients have been excluded.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Ahmed O, Rogers AC, Bolger JC et al. (2018) Meta-analysis of outcomes of endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for the management of acute cholecystitis. Surgical Endoscopy 32: 1627–35

    Systematic review and meta-analysis

    n=495 (5 studies)

    Acute cholecystoenterostomy is a promising alternative to percutaneous cholecystostomy in high-risk patients with acute cholecystitis, with equivalent success rates, improved pain scores and lower re-intervention rates, without the morbidities associated with external drainage.

    A more recent systematic review and meta-analysis is included.

    Ahmed O, Ogura T, Eldahrouty A et al. (2018) Endoscopic ultrasound-guided gallbladder drainage: Results of long-term follow-up. Saudi Journal of Gastroenterology 24: 183–88

    Case series

    n=13

    Follow up: median 240 days

    The rates of technical success, functional success, and adverse events were 100%, 92% and 8%, respectively. Recurrence of cholecystitis was observed in 1 patient (8%).

    Studies with more patients or longer follow up are included.

    Anderloni A, Buda A, Vieceli F et al. (2016) Endoscopic ultrasound-guided transmural stenting for gallbladder drainage in high-risk patients with acute cholecystitis: a systematic review and pooled analysis. Surgical Endoscopy 30: 5200–8

    Systematic review

    n=166 (21 studies)

    Endoscopic ultrasound-guided transmural stenting for gallbladder drainage appears to be feasible, safe, and effective. LAMSs seem to have high potential in terms of efficacy and safety, although further prospective studies are needed.

    A more recent systematic review and meta-analysis is included.

    Auriemma F, Fugazza A, Colombo M et al. (2022) Safety issues in endoscopy ultrasound-guided interventions using lumen apposing metal stents. Minerva Gastroenterol (Torino). 68:177-185

    Review

    Early recognition and management of adverse events associated with LAMS is critical to improve outcomes.

    Only cites 3 studies on EUS-GBD, all of which are included in the overview.

    Chan SM, Teoh AYB, Yip HC et al. (2017) Feasibility of per-oral cholecystoscopy and advanced gallbladder interventions after EUS-guided gallbladder stenting (with video). Gastrointestinal Endoscopy 85: 1225–32

    Cohort study

    n=25

    The recent development of EUS-GBD with a lumen-apposing stent has made endoscopic assessment and advanced gallbladder interventions via the stent possible. Per-oral cholecystoscopy and advanced gallbladder interventions were feasible and safe.

    Study describes interventions that can be done after EUS-GBD.

    Cho DH, Jo SJ, Lee JH et al. (2019) Feasibility and safety of endoscopic ultrasound-guided gallbladder drainage using a newly designed lumen-apposing metal stent. Surgical Endoscopy 33: 2135–41

    Case series

    n=22

    Follow up: median 318 days

    EUS-GBD with newly designed LAMS is feasible and shows acceptable safety profiles for both the urgent drainage of acute cholecystitis and elective internalisation following PT-GBD in patients with high surgical risk.

    Studies with more patients or longer follow up are included.

    Choi JH, Kim HW, Lee J-C et al. (2017) Percutaneous transhepatic versus EUS-guided gallbladder drainage for malignant cystic duct obstruction. Gastrointestinal Endoscopy 85: 357–64

    Non-randomised comparative study

    n=33

    EUS-GBD is a feasible, safe, and effective modality for the treatment of malignant cystic duct obstruction in patients who are not indicated for surgery. It enables improved long-term quality of life in patients with advanced-stage cancer.

    Small study focusing on acute cholecystitis caused by malignant cystic duct obstruction.

    Study is included in the systematic review by Podboy et al. (2022).

    Choi J-H, Lee SS, Choi JH et al. (2014) Long-term outcomes after endoscopic ultrasonography-guided gallbladder drainage for acute cholecystitis. Endoscopy 46: 656–61

    Case series

    n=63

    Follow up: median 275 days

    Technical and clinical success=98%

    Procedural adverse events included duodenal perforation (n=1) and self-limiting pneumoperitoneum (n=2, 3%), all of which resolved with conservative treatment. Late adverse events developed in 4 patients (7%; 95% CI 6% to 8%), including asymptomatic distal stent migration (n=2), and acute cholecystitis due to stent occlusion (n=2). Two patients with occluded stent were successfully treated endoscopically (reintervention rate of 4%). 96% of patients had no recurrence of acute cholecystitis during follow-up.

    Studies with more patients or longer follow up are included.

    Study is included in the systematic review by Mohan et al. (2020) and Fabbri et al. (2022).

    Cucchetti A, Binda C, Dajti E et al. (2022) Trial sequential analysis of EUS-guided gallbladder drainage versus percutaneous cholecystostomy in patients with acute cholecystitis. Gastrointestinal Endoscopy 95: 399–406

    Meta-analysis and trial sequential analysis

    n=535 (4 studies)

    PT-GBD can provide superior technical success than EUS-GBD if a very large sample size is accrued, thus limiting the single-patient benefit. Clinical success is probably equivalent. EUS-GBD decreased overall adverse events and unplanned readmissions, but more studies are needed on the need for reinterventions.

    Only 4 studies were included, all of which are in the overview.

    de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P et al. (2013) EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent.

    Gastrointestinal Endoscopy 77: 303–8

    Case series

    n=13

    Follow up: median 100.8 days

    This pilot study shows that the lumen-apposing stent may be, in the future, a feasible and safe alternative to percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis unsuitable for a surgical approach. However, there are many limitations to this pilot study, so the data may not be generalised. Further prospective, larger, and comparative studies between AXIOS gallbladder drainage and percutaneous transhepatic gallbladder drainage are needed to assess the real efficacy and safety of this novel stent.

    Small case series, included in the systematic reviews by Mohan et al. (2020) and Fabbri et al. (2022).

    Dollhopf M, Larghi A, Will U et al. (2017) EUS-guided gallbladder drainage in patients with acute cholecystitis and high surgical risk using an electrocautery-enhanced lumen-apposing metal stent device. Gastrointestinal Endoscopy 86: 636–43

    Case series

    n=75

    Follow up: mean 201 days

    The novel lumen-apposing metal stent with an electrocautery (ECE-LAMS) on the tip for high-risk surgical patients with acute cholecystitis is safe, with a high technical and clinical success rate. Future multicentre studies comparing EUS-GBD versus PT-GBD are warranted to determine which procedure is safer and clinically more effective for patients with high surgical risk acute cholecystitis.

    Case series, which is included in the systematic reviews by Mohan et al. (2020) and Fabbri et al. (2022).

    Fugazza A, Colombo M, Repici A et al. (2020) Endoscopic ultrasound-guided gallbladder drainage: Current perspectives. Clinical and Experimental Gastroenterology 13: 193–201

    Review

    EUS-GBD is now considered a well-established alternative treatment to surgery in case of acute cholecystitis. The data propose EUS-GBD as a valuable safe and efficient procedure in the long-term follow-up, reducing the risk of further biliary events for fragile patients who do not have cholecystectomy, carrying low rates of adverse events.

    No meta-analysis.

    Garcia-Alonso FJ, Sanchez-Ocana R, Penas-Herrero I et al. (2018) Cumulative risks of stent migration and gastrointestinal bleeding in patients with lumen-apposing metal stents. Endoscopy 50: 386–95

    Cohort study

    n=250

    Follow up: median 75 days

    LAMSs placed for longer durations (such as enteral anastomoses, biliary and gallbladder drainage) presented an 8% cumulative risk of migration at 2 years. Migration was most common when treating pancreatic fluid collections. There were 13 LAMS-related gastrointestinal haemorrhages (5%), 2 of them fatal, presenting a median of 3 days after deployment. The cumulative risk of bleeding at 12 months was 7%.

    Mixed indications.

    Han D, Inamdar S, Lee CW et al. (2018) Lumen apposing metal stents (LAMSs) for drainage of pancreatic and gallbladder collections: a meta-analysis. Journal of Clinical Gastroenterology 52: 835–44

    Systematic review and meta-analysis

    n=993 (20 trials); 181 gallbladder drainage

    Pooled technical success for gallbladder drainage was 95% (95% CI 91% to 99%) and clinical success was 93% (95% CI 90% to 97%).

    A more recent systematic review and meta-analysis is included.

    Higa JT, Sahar N, Kozarek RA et al. (2019) EUS-guided gallbladder drainage with a lumen-apposing metal stent versus endoscopic transpapillary gallbladder drainage for the treatment of acute cholecystitis (with videos). Gastrointestinal Endoscopy 90: 483–92

    Non-randomised comparative study

    n=78

    EUS-GBD has a higher clinical success rate than transpapillary drainage and may be associated with a lower recurrence rate of cholecystitis. However, transpapillary drainage should be considered as the first-line treatment for patients who are surgical candidates but need temporising measures or need an ERCP for other reasons.

    Small retrospective non-randomised comparative study that is included in systematic reviews by Podboy et al. (2021) and Mohan et al. (2020).

    Imai M, Takahashi Y, Sato T et al. (2021) Long-term outcomes of elective EUS-guided gallbladder drainage after percutaneous transhepatic gallbladder drainage. Techniques and Innovations in Gastrointestinal Endoscopy 23: 1–7

    Case series

    n=15

    Both the technical and clinical success rates were 93% (14/15). Two patients (13%) developed adverse events, with distal stent migration in 1 patient and asymptomatic pneumoperitoneum in the other patient. Cholecystitis recurred only in patients who had stent migration.

    The median duration of stent patency was 544 days (18 to 1,006 days), without any deaths. The overall stent patency rate was 87% (13/15).

    Studies with more patients are included.

    Inoue T, Yoshida M, Suzuki Y et al. (2021) Long-term outcomes of endoscopic gallbladder drainage for cholecystitis in poor surgical candidates: An updated comprehensive review. Journal of Clinical Medicine 10: 4842

    Review

    Long-term stent placement with endoscopic gallbladder stenting and EUS-GBD is a therapeutic method that may be a useful option for the prevention of recurrent cholecystitis. It is expected that the efficacy and safety of these procedures will be better established by future studies.

    No meta-analysis.

    Irani S, Ngamruengphong S, Teoh A et al. (2017) Similar efficacies of endoscopic ultrasound gallbladder drainage with a lumen-apposing metal stent versus percutaneous transhepatic gallbladder drainage for acute cholecystitis. Clinical Gastroenterology and Hepatology 15: 738–45

    Non-randomised comparative study

    n=90

    EUS-GBD has similar technical and clinical success compared with PT-GBD and should be considered an alternative for patients who are not candidates for surgery. Patients who have EUS-GBD seem to have shorter hospital stays, lower pain scores, and fewer repeated interventions, with a trend toward fewer adverse events. A prospective, comparative study is needed to confirm these results.

    Small retrospective non-randomised comparative study that is included in systematic reviews by Fabbri et al. (2022), Podboy et al. (2021) and Mohan et al. (2020).

    Irani S, Baron TH, Grimm IS et al. (2015) EUS-guided gallbladder drainage with a lumen-apposing metal stent (with video). Gastrointestinal Endoscopy 82: 1110–5

    Case series

    n=15

    Follow up: median 160 days

    EUS-GBD with a LAMS is technically safe and effective for decompressing the gallbladder for cholecystitis and biliary or cystic duct obstruction in patients who are poor surgical candidates.

    Studies with more patients or longer follow up are included.

    Itoi T, Coelho-Prabhu N, Baron TH (2010) Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointestinal Endoscopy 71: 1038–45

    Systematic review

    n=321 (endoscopic drainage or stenting)

    Although there are now several gallbladder drainage methods to treat acute cholecystitis, the optimal minimally invasive, safe, and reliable treatment method needs to be determined.

    A more recent systematic review and meta-analysis is included.

    Jain D, Bhandari BS, Agrawal N et al. (2018) Endoscopic ultrasound-guided gallbladder drainage using a lumen-apposing metal stent for acute cholecystitis: a systematic review. Clinical Endoscopy 51: 450–62

    Review

    n=189 (10 studies)

    The absence of an external drainage tube and widespread applicability in patients with coagulopathy or ascites make EUS-GBD using LAMS an attractive option for patients with acute cholecystitis in whom surgery is contraindicated.

    More recent systematic reviews are included.

    James T, Baron T (2019) EUS-guided gallbladder drainage: A review of current practices and procedures. Endoscopic Ultrasound 8: 28-s34

    Review

    EUS-GBD is a promising development in the management of cholecystitis, both acute and chronic, in patients unable to have cholecystectomy. Larger comparative studies between percutaneous drain placement and EUS-GBD are required to determine the optimal strategy based on patient characteristics.

    Long-term care of patients who have had EUS-GBD as destination therapy is not well known and additional work is needed to determine the optimal stent exchange interval.

    No meta-analysis.

    James TW, Krafft M, Croglio M et al. (2019) EUS-guided gallbladder drainage in patients with cirrhosis: Results of a multicenter retrospective study. Endoscopy International Open 7: e1099-e1104

    Case series

    n=15

    Follow up: mean 373 days

    Technical and clinical success=93%

    There were 2 adverse events.

    EUS-GBD is safe and efficacious in managing cholecystitis in patients with Child-Pugh A and B cirrhosis who are non-operative candidates.

    Small case series, focusing on EUS-GBD in patients with cirrhosis.

    Jang JW, Lee SS, Song TJ et al. (2012) Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology 142: 805–11

    Randomised controlled trial

    n=59

    EUS-GBD is comparable with PT-GBD in terms of the technical feasibility and efficacy; there were no statistically significant differences in the safety. EUS-GBD is a good alternative for high-risk patients with acute cholecystitis who cannot have an emergency cholecystectomy.

    Studies with more patients or longer follow up are included.

    This study is included in the systematic reviews by Podboy et al. (2021) and Mohan et al. (2020).

    Jang JW, Lee SS, Park DH et al. (2011) Feasibility and safety of EUS-guided transgastric/ transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointestinal endoscopy 74: 176–81

    Case series

    n=15

    Follow up: median 145 days

    Placement of a modified covered self-expandable metal stent after EUS-guided transgastric or transduodenal gallbladder drainage may be a feasible and safe alternative to treatments such as percutaneous cholecystostomy in patients with acute cholecystitis who are unsuitable for cholecystectomy.

    Studies with more patients or longer follow up are included.

    Study is included in systematic review by Fabbri et al. (2022).

    Kalva NR, Vanar V, Forcione D et al. (2018) Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: a meta-analysis and systematic review. Canadian Journal of Gastroenterology & Hepatology: 7070961

    Systematic review and meta-analysis

    n=233 (13 studies)

    Pooled proportion of technical success was 94% (95% CI 91 to 97%) and clinical success was 93% (95% CI 89 to 95%). Overall complication rate was 18% (95% CI 14% to 24%) and stent related complication rate was 8% (95% CI 4 to 15%) in the pooled percentage of patients. Pooled proportion for perforation was 7% (95% CI 4 to 11%) and recurrent cholangitis or cholecystitis was noted in 4% (95% CI 2 to 8%).

    A more recent systematic review and meta-analysis is included.

    Kahaleh M, Perez-Miranda M, Artifon EL et al. (2016) International collaborative study on EUS-guided gallbladder drainage: Are we ready for prime time? Digestive and Liver Disease 48: 1054–7

    Registry

    n=35

    Follow up: median 91.5 days

    EUS-GBD appears to be feasible, safe, and effective. Prospective studies are needed to confirm these findings and identify the best technique to use

    Studies with more patients or longer follow up are included.

    Study is included in systematic review by Fabbri et al. (2022).

    Kalva NR, Vanar V, Forcione D et al. (2018) Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: a meta-analysis and systematic review. Canadian Journal of Gastroenterology & Hepatology 2018: 7070961

    Systematic review and meta-analysis

    n=233 (13 studies)

    EUS-GBD with LAMS is a safe and alternative treatment for patients needing gallbladder drainage, with acceptable intraprocedural and postprocedural complications. However, further controlled trials are necessary to estimate the overall efficacy and safety and the role of EUS-GBD with LAMS in management of nonoperative patients with acute cholecystitis.

    A more recent systematic review and meta-analysis is included.

    Kamata K, Takenaka M, Kitano M et al. (2017) Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: Long-term outcomes after removal of a self-expandable metal stent. World Journal of Gastroenterology 23: 661–7

    Case series

    n=12

    Follow up: median 304 days

    Long-term outcomes after removal of the self-expandable metal stent were excellent. Removal of the stents 4 weeks after placement and improvement of symptoms might avoid migration of the stent and recurrence of cholecystitis due to food impaction.

    Studies with more patients or longer follow up are included.

    Study is included in systematic review by Fabbri et al. (2022).

    Kanno Y, Kozakai F, Koshita S et al. (2019) Technical issues stemming from endoscopic-ultrasound-guided gallbladder drainage: A single center experience. The Turkish Journal of Gastroenterology 30: 1055–61

    Case series

    n=18

    The rates of technical success, clinical effectiveness, severe adverse event occurrence, and recurrence of acute cholecystitis were 94% (17/18), 88% (15/17), 6% (1/18, massive bile leakage), and 27% (4/15), respectively. Distal gastrectomy causing scope instability, the non-swollen gallbladder, and double pigtail stent use caused technical difficulties.

    Studies with more patients or longer follow up are included.

    Study is included in systematic review by Fabbri et al. (2022).

    Khan MA, Atiq O, Kubiliun N et al. (2017) Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage?

    Gastrointestinal Endoscopy 85: 76–87

    Systematic review and meta-analysis

    n=809 (23 studies)

    Endoscopic gallbladder drainage is an efficacious and safe therapeutic modality for treatment of patients with acute cholecystitis who cannot undergo surgery. It shows a similar technical success as PT-GBD but appears to be safer.

    A more recent systematic review and meta-analysis is included.

    Kozakai F, Kanno Y, Ito K et al. (2019) Endoscopic ultrasonography-guided gallbladder drainage as a treatment option for acute cholecystitis after metal stent placement in malignant biliary strictures. Clinical Endoscopy 52: 262–8

    Non-randomised comparative study

    n=48

    EUS-GBD after metal stent placement was a feasible option for treating acute cholecystitis.

    Studies with more patients or longer follow up are included.

    Krishnamoorthi R, Jayaraj M, Thoguluva C V (2020) EUS-guided versus endoscopic transpapillary gallbladder drainage in high-risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Surgical Endoscopy 34: 1904–13

    Systematic review and meta-analysis

    n=857 (5 studies); 259 endoscopic ultrasound-guided

    EUS-GBD has higher rate of technical and clinical success compared to endoscopic transpapillary GBD. While the rates of overall adverse events are statistically similar, EUS-GBD has a lower rate of recurrent cholecystitis.

    A more recent systematic review and meta-analysis is included.

    Lisotti A, Napoleon B, Fabbri C et al. (2022) Treatment of acute cholecystitis in high-risk surgical patients. Minerva Gastroenterology 68: 154–61

    Systematic review

    175 papers

    The levels of evidence in the literature have evolved from initial descriptive studies to recent randomised controlled trials and meta-analysis of cohort studies. While several articles addressed the comparison among different techniques, some topics and questions are still debated.

    No meta-analysis.

    Lisotti A, Linguerri R, Bacchilega I et al. (2022) EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-procedure outcomes and evaluation of mortality predictors. Surgical Endoscopy 36: 569–78

    Case series

    n=25

    Technical, clinical success rate and adverse events rate were 92%, 88%, and 16%, respectively. 30-day and 1-year mortality were 12% and 32%. Severe comorbidities and acute kidney injury were independent predictive factors confirming of long-term mortality after EUS-GBD.

    Studies with more patients or longer follow up are included.

    Luk S, Irani S, Krishnamoorthi R et al. (2019) Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy 51: 722–32

    Systematic review and meta-analysis

    n=495 (5 studies)

    Endoscopic ultrasound guided gallbladder drainage was associated with lower rates of post-procedure adverse events, shorter hospital stays, and fewer reinterventions and readmissions compared with percutaneous cholecystostomy in patients with acute cholecystitis who could not have surgery.

    A more recent systematic review and meta-analysis is included.

    Luo X, Sharaiha R, Teoh AYB (2022) Endoscopic Management of Acute Cholecystitis. Gastrointestinal Endoscopy Clinics of North America 32: 527–43

    Review

    Endoscopic management of acute cholecystitis in high surgical risk patients is recommended in tertiary hospitals whereby expertise, resources, and technical support are available.

    In patients who cannot have surgery, PT-GBD, ETP-GBD), and EUS-GBD are effective and safe alternative procedures to cholecystectomy.

    EUS-GBD is preferred over PT-GBD because of similar rates of technical success and reduced rates of reintervention and unplanned readmissions.

    LAMS are associated with reduced risks of adverse events such as bile peritonitis and perforation compared with plastic stents and these stents should be used for EUS-GBD.

    EUS-GBD is associated with a steeper learning curve and should be done in high volume endoscopy centres where expertise is available.

    No meta-analysis.

    Lyu Y, Li T, Wang B et al. (2021) Comparison of three methods of gallbladder drainage for patients with acute cholecystitis who are at high surgical risk: a network meta-analysis and systematic review. Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A; 31: 1295–1302

    Systematic review and network meta-analysis

    13 studies

    Endoscopic ultrasound-guided bladder drainage was associated with the highest probability of clinical success (68%), and the lowest prevalence of adverse events (57%) and recurrent cholecystitis (61%).

    Another systematic review and network meta-analysis with a more recent paper is included.

    Lyu Y, Li T, Wang B et al. (2021) Endoscopic ultrasound-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage for acute cholecystitis with high surgical risk: an up-to-date meta-analysis and systematic review. Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A; 31: 1232–240

    Systematic review and meta-analysis

    n=801 (8 studies)

    Endoscopic ultrasound-guided bladder drainage was comparable to percutaneous gallbladder drainage regarding clinical success, with less reintervention and readmission, for acute cholecystitis with high surgical risk. The cholecystitis recurrence rate was lower with EUS-GBD with LAMS.

    A more recent systematic review and meta-analysis is included.

    Manta R, Mutignani M, Galloro G et al. (2018) Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis with a lumen-apposing metal stent: a systematic review of case series. European Journal of Gastroenterology & Hepatology 30: 695–98

    Systematic review

    n=226 (9 studies)

    Follow up: median 6 months (range 2 to 12 months)

    The stent was positioned successfully in 95% (215/226) of patients (95% CI 92 to 98%).

    Clinical success=92% (207/226) at intention-to-treat analysis and 96% at per-protocol analysis. A total of 24 (11%) adverse events occurred, including 11 during the procedure, and 13 observed at follow up.

    A more recent systematic review and meta-analysis is included.

    Matsubara S, Isayama H, Nakai Y et al. (2020) Endoscopic ultrasound-guided gallbladder drainage with a combined internal and external drainage tubes for acute cholecystitis. Journal of Gastroenterology and Hepatology 35: 1821–27

    Feasibility study

    n=23

    Follow up: 6 months

    EUS-GBD with a combination of double pigtail plastic stent and naso-cystic tube is considered an effective and safe technique both as bridge to surgery and palliation.

    Studies with more patients or longer follow up are included.

    McCarty T, Hathorn K, Bazarbashi A et al. (2021) Endoscopic gallbladder drainage for symptomatic gallbladder disease: a cumulative systematic review meta‑analysis. Surgical Endoscopy 35: 4964–4985

    Systematic review and meta-analysis

    n=1,538 (36 studies)

    Endoscopic gallbladder drainage is a safe and effective treatment for high-risk surgical candidates with symptomatic gallbladder disease. EUS-guided transmural drainage is superior to transpapillary drainage and associated with a lower rate of reintervention compared to percutaneous transhepatic drainage.

    A more recent systematic review is included.

    Minaga K, Yamashita Y, Ogura T et al. (2019) Clinical efficacy and safety of endoscopic ultrasound-guided gallbladder drainage replacement of percutaneous drainage: A multicenter retrospective study. Digestive Endoscopy 31: 180–87

    Case series

    n=21

    Where ongoing gallbladder drainage is needed, conversion from PT-GBD to EUS-GBD is a feasible, effective, and safe technique for patients who cannot have cholecystectomy.

    Studies with more patients or longer follow up are included.

    Mohan B, Asokkumar R, Shakhatreh M et al. (2019) Adverse events with lumen-apposing metal stents in endoscopic gallbladder drainage: A systematic review and meta-analysis. Endoscopic Ultrasound 8: 241–48

    Systematic review and meta-analysis

    n=393 (8 studies)

    The overall rate of adverse events with LAMS was 13%. Early adverse event risk appeared to be 6.5% and delayed risk appeared to be 8%.

    Review focuses on adverse events associated with LAMS.

    Nishiguchi K, Ogura T, Okuda A et al. (2021) Endoscopic gallbladder drainage for acute cholecystitis with high-risk surgical patients between transduodenal and transpapillary stenting. Endoscopic Ultrasound 10: 448–54

    Non-randomised comparative study

    n=54

    Follow up: median 522 days

    Technical success rate and procedure time were significantly superior in the EUS-GBD group than in the ETP-GBD group. Recurrent acute cholecystitis tended to be more frequent in the ETP-GBD group, and clinical success tended to be more favourable in the EUS-GBD group, although these 2 variables did not differ significantly between groups.

    Studies with more patients or longer follow up are included.

    Ogura T, Nishioka N, Yamada M et al. (2021) EUS-guided gallbladder drainage using an improved self-expandable covered metal stent with anti-stent migration system (with video). Digestive Diseases (Basel, Switzerland) 39: 150–5

    Feasibility study

    n=12

    Follow up: median 189 days

    EUS-GBD was successfully done in all patients without any adverse events, and clinical success was achieved in all patients. In 4 patients, stents were successfully removed after 3 months. No stent migration was seen.

    Studies with more patients or longer follow up are included.

    Study is included in the systematic review by Fabbri et al. (2022).

    Ogura T, Higuchi K (2019) Endoscopic ultrasound-guided gallbladder drainage: Current status and future prospects. Digestive endoscopy 31: 55–64

    Review

    Compared with PT-GBD, EUS-GBD involves internal drainage. It is a technically simple procedure compared with ETP-GBD. However, the results of long-term follow up are still unclear, and there is still insufficient evidence on performance of EUS-GBD as the first-line drainage technique.

    More recent systematic reviews are included.

    Oh D, Song TJ, Cho DH et al. (2019) EUS-guided cholecystostomy versus endoscopic transpapillary cholecystostomy for acute cholecystitis in high-risk surgical patients. Gastrointestinal Endoscopy 89: 289–98

    Non-randomised comparative study

    n=172

    Follow up: mean 19 months (for EUS-GBD)

    In patients with acute cholecystitis for whom surgery is unsuitable, EUS-GBD may be a more suitable treatment method than endoscopic transpapillary cholecystostomy.

    Retrospective non-randomised comparative study that is included in systematic reviews by Fabbri et al. (2022), Podboy et al. (2021) and Mohan et al. (2020).

    Park SW, Lee SS (2022) Current status of endoscopic management of cholecystitis. Digestive Endoscopy 34: 439–50

    Review

    Endoscopic treatments such as EUS-GBD or ETP-GBD are minimally invasive, safe, and reliable. However, they have not yet been established as standard procedures and their roles are limited to treat those who are unfit for cholecystectomy. Furthermore, although no conclusion has been reached regarding which approach is preferred, these procedures should be commonly considered by skilled endoscopists practicing in high-volume institutes.

    No meta-analysis.

    Penas-Herrero I, de la Serna-Higuera C, Perez-Miranda M (2015) Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video). Journal of Hepato-Biliary-Pancreatic Sciences 22: 35–43

    Systematic review

    n=155 (with acute cholecystitis)

    Overall, technical success was 97.5% and clinical success was 99.3% in patients with acute cholecystitis. Adverse events developed in less than 8% of patients, all of them managed conservatively.

    A more recent systematic review and meta-analysis is included.

    Posner H, Widmer J. (2020) EUS guided gallbladder drainage. Translational Gastroenterology and Hepatology 5: 41

    Review

    EUS-GBD is overall a promising technique, which is being used in increasing numbers at expert centres internationally. With impressive technical and clinical success rates with low rates of adverse events, it should be considered for non-surgical candidates with acute cholecystitis.

    A more recent systematic review and meta-analysis is included.

    Rajadurai A, Zorron CTPL, Cameron R et al. (2022) Endoscopic ultrasound-guided gallbladder and bile duct drainage with lumen apposing metal stent: A large multicenter cohort (with videos). Journal of Gastroenterology and Hepatology 37: 179–89

    Cohort study

    n=49 (EUS-GBD)

    Follow up: median 49 days

    Technical success for EUS-GBD was 96% (47/49) and clinical success was 80% (39/49). No patients needed subsequent cholecystectomy. 30-day mortality was 14.3%. The procedure-related mortality was caused by biliary sepsis (2/49, 4%)

    or aspiration (3/49, 6%).

    Studies with more patients or longer follow up are included.

    Rerknimitr R, Pham KC (2020) Practical approaches for high-risk surgical patients with acute cholecystitis: The percutaneous approach versus endoscopic alternatives. Clinical Endoscopy 53: 678–85

    Review

    Although EUS-GBD has the highest technical and clinical success rates over ETP-GBD and PT-GBD for gallbladder drainage especially when it is performed by experienced therapeutic endoscopists, it may not be the first option if laparoscopic cholecystectomy is planned.

    No meta-analysis.

    Sagami R, Hayasaka K, Nishikiori H et al. (2020) Current status in the treatment of acute cholecystitis patients receiving antithrombotic therapy: Is endoscopic drainage feasible? A systematic review. Clinical Endoscopy 53: 176–88

    Systematic review

    54 studies (26 on endoscopic ultrasound-guided gallbladder drainage)

    The overall technical success, clinical success, and bleeding complication rates of endoscopic transpapillary versus EUS-GBD were 84% versus 96% (p<0.001), 92% versus 97% (p<0.001) and 0.65% versus 2.1% (p=0.005), respectively.

    A more recent systematic review and meta-analysis is included.

    Sagami R, Hayasaka K, Ujihara T et al. (2020) Feasibility of endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis patients receiving antithrombotic therapy. Annals of Gastroenterology 33: 391–97

    Case series

    n=12

    Follow up: mean 261 days

    EUS-GBD yielded high technical and clinical success rates and a low recurrence rate.

    No patients on antithrombotic therapy developed bleeding complications.

    Small case series, focusing on patients who are on antithrombotic therapy.

    Saumoy M, Yang J, Bhatt A et al. (2021) Endoscopic therapies for gallbladder drainage. Gastrointestinal Endoscopy 94: 671–84

    Review

    Nonsurgical gallbladder drainage is recommended for management of acute cholecystitis in patients deemed high risk for surgical cholecystectomy. Selection of the optimal technique (PT-GBD, ETP-GBD, or EUS-GBD) should be individualised

    and determined using a multidisciplinary approach based on clinical determinants and available procedural expertise.

    No meta-analysis.

    Saumoy M, Tyberg A, Brown E et al. (2019) Successful cholecystectomy after endoscopic ultrasound gallbladder drainage compared with percutaneous cholecystostomy, can it be done? Journal of Clinical Gastroenterology 53: 231–35

    Cohort study

    n=34

    Surgical cholecystectomy after EUS-GBD with lumen apposing metal stent is safe and feasible for the management of cholecystitis. If patient's underlying medical conditions improve, previous EUS-GBD should not preclude patients from undergoing cholecystectomy as part of standard of care.

    Small study focusing on the feasibility of cholecystectomy after EUS-GBD.

    Small AJ, Irani S (2018) EUS-guided gallbladder drainage vs. percutaneous gallbladder drainage. Endoscopic Ultrasound 7: 89–92

    Review

    EUS-guided GBD is a viable alternative for patients with cholecystitis needing nonsurgical drainage. Transmural placement of LAMSs can permit permanent drainage with minimal adverse events and has several reported advantages over percutaneous cholecystostomy tubes. EUS internal GBD should be reserved for poor operative candidates and done by highly experienced therapeutic echoendosonographers until additional evidence is accrued.

    No meta-analysis.

    Sobani ZA, Ling C, Rustagi T (2021) Endoscopic ultrasound-guided gallbladder drainage. Digestive Diseases and Sciences 66: 2154–61

    Review

    With multiple available options the method of gallbladder decompression in non-surgical candidates should be carefully evaluated and tailored to individual patient. When done by skilled endoscopists at high-volume centres, EUS-GBD is an effective and safe alternative therapy for gallbladder drainage with high technical success rate and better long-term clinical outcomes compared to PT-GBD.

    No meta-analysis.

    Takagi W, Ogura T, Sano T et al. (2016) EUS-guided cholecystoduodenostomy for acute cholecystitis with an anti-stent migration and anti-food impaction system; A pilot study. Therapeutic Advances in Gastroenterology 9: 19–25

    Case series

    n=16

    Follow up: median 181.5 days

    Technical and clinical success were 100%.

    There were no recurrences of acute cholecystitis. Pneumoperitoneum was seen in one patient.

    Studies with more patients or longer follow up are included.

    Study is included in the systematic reviews by Fabbri et al. (2022) and Mohan et al. (2020).

    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 33: 1139–45

    Cohort study

    n=27 (EUS-GBD)

    Follow up: mean 197 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 patients or longer follow up are included.

    Teoh A (2019) Outcomes and limitations in EUS-guided gallbladder drainage. Endoscopic Ultrasound 8: 40-s43

    Review

    EUS-GBD is a safe and effective procedure for the treatment of acute cholecystitis in patients that are at high-risk for cholecystectomy. It also opens up new windows for endoscopic intervention to the gallbladder that was previously impossible. Data from large scale randomised studies are awaited to confirm the efficacy of the procedure.

    No meta-analysis.

    Teoh AYB, Serna C, Penas I et al. (2017) Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy 49: 130–8

    Non-randomised comparative study

    n=118

    EUS-GBD and percutaneous cholecystostomy were both effective means of achieving gallbladder drainage. EUS-GBD may be a promising alternative to percutaneous cholecystostomy for treating acute cholecystitis in patients for whom surgery is unsuitable, provided that experienced endosonographers are available.

    Studies with more patients or longer follow up are included.

    Study is included in systematic reviews by Fabbri et al. (2022), Podboy et al. (2021) and Mohan et al. (2020).

    Torres Yuste R, Garcia-Alonso FJ, Sanchez-Ocana R et al. (2020) Safety and efficacy of EUS-guided gallbladder drainage combined with ERCP in the same session. Digestive Endoscopy 32: 608–15

    Cohort study

    n=71

    Single-session EUS-GBD combined with ERCP has comparable rates of technical and clinical success to EUS-GBD alone. A combined EUS-GBD and ERCP procedure does not appear to increase adverse events and makes possible comprehensive treatment of gallstone disease by purely endoscopic means.

    Study assesses outcomes when the procedure is combined with ERCP.

    Toy G, Adler DG (2022) Nonsurgical gallbladder drainage: percutaneous and endoscopic approaches. Techniques and Innovations in Gastrointestinal Endoscopy 24: 90–97

    Review

    Technical and clinical success rates are similar between the percutaneous and transmural approaches which are higher than those in the transpapillary approach. Taken together, the endoscopic approaches are associated with shorter hospital stays and readmissions. Mortality rates are similar in all the approaches.

    Systematic reviews with meta-analyses are included.

    Tyberg A, Jha K, Shah S et al. (2020) EUS-guided gallbladder drainage: A learning curve modified by technical progress. Endoscopy International Open 8: e92-e96

    Case series

    n=48

    Follow up: mean 5.4 months

    Endoscopists experienced in EUS-GBD are expected to achieve a reduction in procedure time over successive cases, with efficiency reached at 41 minutes and a learning rate of 19 cases. Continued improvement is demonstrated with additional experience.

    Studies with more patients or longer follow up are included.

    Tyberg A, Saumoy M, Sequeiros EV et al. (2017) EUS-guided versus percutaneous gallbladder drainage. Journal of Clinical Gastroenterology 52: 79–84

    Non-randomised comparative study

    n=155

    EUS-GBD is safe and efficacious, with comparable technical and clinical success rates and no difference in adverse events to PT-GBD. In addition, EUS-GLB offers a potential cost-saving benefit and morbidity benefit by demonstrating fewer repeat interventions.

    Retrospective non-randomised comparative study that is included in systematic reviews by Podboy et al. (2021) and Mohan et al. (2020).

    Walter D, Teoh AY, Itoi T et al. (2016) EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut 65: 6–8

    Case series

    n=30

    Follow up: mean 298 days

    Technical success=90% (27/30) and clinical success=96% (26/27). 7% (2/27) of patients (7%) developed recurrent cholecystitis due to LAMS obstruction. Successful LAMS removal was done in 50% (15/30) of patients after a mean of 91 days. In 15 patients, no LAMS removal was done because of death (n=5), significant tissue overgrowth (n=2) or other causes (n=8). 15 serious adverse events were reported, including 4 that were possibly stent-related or procedure-related (13%). Overall mortality was 23% (7/30), with 30-day mortality of 17% (5/30).

    Studies with more patients or longer follow up are included.

    Study is included in the systematic review by Mohan et al. (2020).

    Yoo HW, Moon JH, Jo SJ et al. (2021) A novel electrocautery-enhanced delivery system for one-step endoscopic ultrasound-guided drainage of the gallbladder and bile duct using a lumen-apposing metal stent: a feasibility study. Endoscopy 53: 922–26

    Case series

    n=17

    Technical success=94%

    Clinical success=100%

    Overall adverse event rate=18%

    Studies with more patients or longer follow up are included.