Interventional procedure overview of endoluminal gastroplication for gastro-oesophageal reflux disease
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/follow up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
Antoniou SA, Koch OO, Kaindlstorfer A et al. (2012) Endoscopic full-thickness plication versus laparoscopic fundoplication: a prospective study on quality of life and symptom control. Surgical Endoscopy 26(4): 1063–8. | RCT | Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GORD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates. | Studies with more patients or longer follow up are included. |
Barnes WE, Hoddinott KM, Mundy S et al. (2011) Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GORD in community practice. Surgical Innovation 18(2): 119–29. | Case series | At a median 7-month follow up (range 5-17), typical and atypical symptom scores were normalized in 75% to 80% of patients, proton pump inhibitors (PPIs) were completely discontinued by 93%, and 83% were satisfied with their current health condition. Endoscopy in 53 patients revealed Hill grade I tight valves in 89% of the cases, reduced hiatal hernia in 33/34 (97%), and healed reflux oesophagitis in 25/30 (83%). Based on global analysis, 72% of the patients were in remission, 20% improved symptomatically, and only 8% had ongoing GORD. These results supported the safety and efficacy of TIF as well as encouraged its application as an alternative treatment of GORD refractory to PPIs. | More recent studies are included. |
Bell RCW, Barnes WE, Carter BJ et al. (2014) Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. The American Surgeon 80(11): 1093–1105. | Case series | GORD Health related Quality of Life and regurgitation scores improved by 50 per cent or greater in 63 of 96 (66%) and 62 of 88 (70%) patients who had elevated preoperative scores. The Reflux Symptom Index score normalized in 53 of 82 (65%) patients. Daily PPI use decreased from 91 to 29 per cent. In patients amenable to postoperative testing, oesophagitis healed in 12 of 16 (75%) and oesophageal acid exposure normalized in eight of 14 (57%). TIF safely achieved sustained symptomatic control over a 2-year period in two-thirds of patients with a virtual absence of de novo side effects. | Study included in Grössmann (2021) HTA and McCarty (2018) systematic review. |
Bell RCW, Fox MA, Barnes WE et al. (2014) Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication. Surgical Endoscopy 28(10): 2949–58. | Case series | Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy. | Likely significant patient overlap with Bell (2014), which is included in Grössmann (2021) HTA and McCarty (2018) systematic review. |
Bell RCW, Hufford RJ, Fearon J et al. (2013) Revision of failed traditional fundoplication using EsophyX transoral fundoplication. Surgical Endoscopy 27(3): 761–7. | Case series | Transoral revision of failed traditional fundoplication without herniation is technically feasible. It results in symptomatic and objective improvement of GORD without the risks of laparoscopic dissection for a majority of patients. | Studies with more patients or longer follow up are included. |
Bell RCW, Mavrelis PG, Barnes WE et al. (2012) A prospective multicenter registry of patients with chronic gastro-oesophageal reflux disease receiving transoral incisionless fundoplication. Journal of the American College of Surgeons 215(6): 794–809. | Case series | Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GORD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow up. | Studies with more patients or longer follow up are included. |
Cadiere G, Rajan A, Germay O et al. (2008) Endoluminal fundoplication by a transoral device for the treatment of GORD: a feasibility study. Surgical Endoscopy and Other Interventional Techniques 22(2): 333–42. | Case series | The study demonstrated technical feasibility and safety of the ELF procedure using the EsophyXTM device. The study also demonstrated maintenance of the anatomical integrity of the ELF valves for 12 months and provided preliminary data on ELF efficacy in reducing the symptoms and medication use associated with GORD. | Studies with more patients or longer follow up are included. |
Chen D, Barber C, McLoughlin P et al. (2009) Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. British Journal of Surgery 96(2): 128–36. | Systematic review | At present there is insufficient evidence to determine the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease, particularly in the long term. | A more recent systematic review (McCarty 2018) is included. |
Chen S, Jarboe MD, Teitelbaum DH (2012) Effectiveness of a transluminal endoscopic fundoplication for the treatment of pediatric gastro-oesophageal reflux disease. Pediatric Surgery International 28(3): 229–34. | Case series | The TIF procedure can complement the current surgically and medically available options for children with GORD, especially in complicated patients such as those with NI. However, complications including hemorrhage emphasize the potential risk of the procedure. Further studies with more patients and a longer follow up course must be conducted to better assess efficacy. | Studies with more patients or longer follow up are included. |
Choi AY, Roccato MK, Samarasena JB et al. (2021) Novel Interdisciplinary Approach to GORD: Concomitant Laparoscopic Hiatal Hernia Repair with Transoral Incisionless Fundoplication. Journal of the American College of Surgeons 232(3): 309–18. | Case series | The results suggest that cTIF is safe and effective in reducing reflux symptoms in a large spectrum of GORD patients. | Studies with more patients or longer follow up are included. |
Coronel MA, Bernardo WM, Moura DTH de et al. (2018) The efficacy of the different endoscopic treatments versus sham, pharmacologic or surgical methods for chronic gastro-oesophageal reflux disease: a systematic review and meta-analysis. Arquivos de Gastroenterologia 55(3): 296–305. | Systematic review | This systematic review and meta-analysis shows a good short term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies. | Larger systematic review (McCarty 2018) included. |
Ebright MI, Sridhar P, Litle VR et al. (2017) Endoscopic Fundoplication: Effectiveness for Controlling Symptoms of Gastro-oesophageal Reflux Disease. Innovations 12(3): 180–5. | Case series | At a mean follow up of 24 months, TIF is effective. Although symptoms and satisfaction improved significantly, many patients continued to take PPIs. Future studies should focus on longer-term durability and comparisons with laparoscopic techniques. | Studies with more patients or longer follow up are included. |
Gerson L, Stouch B, Lobontiu A (2018) Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials. Chirurgia (Bucur) 113(2): 173–84. | Meta analysis | In a meta-analysis of randomized controlled trials (RCTs), the TIF procedure data for patients with GORD refractory to PPIs produces significant changes, compared with sham or PPI therapy, in oesophageal pH, decreased PPI utilization, and improved quality of life. | Larger systematic review with meta-analysis (McCarty 2018) included. |
Gisi C, Wang K, Khan F et al. (2021) Efficacy and patient satisfaction of single-session transoral incisionless fundoplication and laparoscopic hernia repair. Surgical Endoscopy 35(2): 921–7. | Case series | The majority of patients reported 75% or greater satisfaction with the procedure and had an improvement in GORD symptoms as well as decreased PPI use. There were no serious adverse events. | Studies with more patients or longer follow up are included. |
Hakansson B, Montgomery M, Cadiere GB et al. (2015) Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GORD. Alimentary Pharmacology & Therapeutics 42(1112): 1261–70. | RCT | Transoral incisionless fundoplication (TIF2) is effective in chronic PPI-dependent GORD patients when followed up for 6 months. | Studies with more patients or longer follow up are included. |
Hillman L, Yadlapati R, Whitsett M et al. (2017) Review of antireflux procedures for proton pump inhibitor nonresponsive gastro-oesophageal reflux disease. Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus 30(9): 1–14. | Systematic review | Laparoscopic fundoplication remains the most proven therapeutic approach. Newer antireflux procedures such as magnetic sphincter augmentation and transoral incisionless fundoplication offer alternatives with varying degrees of success, durability, and side effect profiles that may better suit individual patients. Larger head-to-head comparison trials are needed to better characterize the difference in symptom response and side effect profiles. | No meta-analysis. |
Huang X, Chen S, Zhao H et al. (2017) Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GORD: a systematic review with meta-analysis. Surgical Endoscopy 31(3): 1032–44. | Systematic review and meta-analysis | TIF is an alternative intervention in controlling GORD-related symptoms with comparable short-term patient satisfaction. Long-term results showed decreased efficacy with time. Patients often resume PPIs at reduced doses in the near future. | Larger systematic review with (McCarty 2018) included. |
Hunter JG, Dolan JP, Diggs BS et al. (2015) Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology 148(2): 324–33. | RCT | TIF was an effective treatment for patients with GORD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. | Studies with more patients or longer follow up are included. |
Huynh P, Konda V, Sanguansataya S et al. (2021) Mind the Gap: Current Treatment Alternatives for GORD Patients Failing Medical Treatment and Not Ready for a Fundoplication. Surgical Laparoscopy, Endoscopy and Percutaneous Techniques 31(2): 264–76. | Systematic review | Variable freedom from PPI was reported at 1 year for RFA with a weighted mean of 62%, TIF with a weighted mean of 61%, MSA with a weighted mean of 85%, and fundoplications with a weighted mean of 84%. All procedures including PPIs improved quality-of-life scores but were not equal. Fundoplication had the best improvement followed by MSA, TIF, RFA, and PPI, respectively. DeMeester scores are variable after all procedures and PPIs. All MSA studies showed normalization of pH, whereas only 4 of 17 RFA studies and 3 of 11 TIF studies reported normalization of pH. | No meta-analysis. |
Ihde GM, Besancon K, Deljkich E (2011) Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastro-oesophageal reflux disease. American Journal of Surgery 202(6): 740-7 | Case series | The results support the safety and symptomatic improvement of TIF with or without laparoscopic hiatal hernia repair. The patients' symptoms were significantly improved, and PPI use was significantly reduced. | Studies with more patients or longer follow up are included. |
Ihde GM, Pena C, Scitern C et al. (2019) pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. Journal of the Society of Laparoendoscopic Surgeons 23(1): e2018.00087 | Case series | Hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with | Mixed interventions |
Janu P, Shughoury AB, Venkat K et al. (2019) Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surgical Innovation 26(6): 675–86. | Case series | Hiatal hernia repair and TIF provides significant symptom control for heartburn and regurgitation with no long-term dysphagia or gas bloat normally associated with traditional antireflux procedures. Most patients reported durable symptom control and satisfaction with health condition at 12 months. | Mixed interventions |
Kaindlstorfer A, Koch OO, Antoniou SA et al. (2013) A randomized trial on endoscopic full-thickness gastroplication versus laparoscopic antireflux surgery in GORD patients without hiatal hernias. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 23(2): 212–22. | RCT | Improvements in the general subjective outcome parameters were similar after endoscopic full-thickness gastroplication compared with LARS despite a stronger reflux control provided by LARS. More effective relief of reflux-related symptoms favors LARS, and differences in side effect symptoms favor endoscopic full-thickness gastroplication. | Studies with more patients or longer follow up are included. |
Kaindlstorfer A, Koch OO, Berger J et al. (2012) Full-thickness gastroplication for the treatment of gastro-oesophageal reflux disease: short-term results of a feasibility clinical trial. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 22(6): 503–8. | Case series | Endoscopic full-thickness plication is a safe and well-tolerated procedure that significantly improves quality of life and eliminates gastro-oesophageal reflux disease symptoms in the majority of patients, without side effects seen after laparoscopic fundoplication. | Studies with more patients or longer follow up are included. |
Kim HJ, Kwon C-I, Kessler WR et al. (2016) Long-term follow up results of endoscopic treatment of gastro-oesophageal reflux disease with the MUSE TM endoscopic stapling device. Surgical Endoscopy 30(8): 3402–8. | Case series | The MUSE stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GORD. These results appeared to be equal to or better than those of the other devices for endoluminal GORD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited. | Studies with more patients or longer follow up are included. |
Koch OO, Kaindlstorfer A, Antoniou SA et al. (2013) Subjective and objective data on oesophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GORD by using multiple plication implants. Gastrointestinal Endoscopy 77(1): 7–14. | Case series | Endoscopic plication is safe and improves objective and subjective parameters at 1-year followup, without side effects seen after laparoscopic fundoplication. Further studies on the clinical merit of this procedure in specific patient populations are warranted. | Studies with more patients or longer follow up are included. |
Muls V, Eckardt AJ, Marchese M et al. (2013) Three-year results of a multicenter prospective study of transoral incisionless fundoplication. Surgical Innovation 20(4): 321–30. | Case series | The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive oesophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability. | Studies with more patients or longer follow up are included. |
Narsule CK, Burch MA, Ebright MI et al. (2012) Endoscopic fundoplication for the treatment of gastro-oesophageal reflux disease: initial experience. The Journal of Thoracic and Cardiovascular Surgery 143(1): 228–34. | Case series | TIF is effective at short-term follow up and safe for patients with GORD. However, long-term follow up and randomised trials are required to assess the efficacy and durability of this approach compared with conventional surgical repair. | Studies with more patients or longer follow up are included. |
Nguyen A, Vo T, Nguyen X-MT et al. (2011) Transoral incisionless fundoplication: initial experience in patients referred to an integrated academic institution. The American Surgeon 77(10): 1386–9. | Case series | Transoral incisionless fundoplication is technically safe in well-selected patients including those with prior oesophageal and gastric surgery. | Studies with more patients or longer follow up are included. |
Petersen RP, Filippa L, Wassenaar EB et al. (2012) Comprehensive evaluation of endoscopic fundoplication using the EsophyX TM device. Surgical Endoscopy 26(4): 1021–7. | Case series | Endoscopic fundoplication is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GORD. | Studies with more patients or longer follow up are included. |
Richter JE, Kumar A, Lipka S et al. (2018) Efficacy of Laparoscopic Nissen Fundoplication vs Transoral Incisionless Fundoplication or Proton Pump Inhibitors in Patients With Gastro-oesophageal Reflux Disease: A Systematic Review and Network Meta-analysis. Gastroenterology 154(5): 1298-1308. | Systematic review and meta-analysis | In this systematic review and network meta-analysis of trials of patients with GORD, LNF was found to have the greatest ability to improve physiologic parameters of GORD, including increased LES pressure and decreased percent time pH <4. Although TIF produced the largest increase in health-related quality of life, this could be due to the shorter follow up time of patients treated with TIF vs LNF or PPIs. TIF is a minimally invasive endoscopic procedure, yet based on evaluation of benefits vs risks, we do not recommend it as a long-term alternative to PPI or LNF treatment of GORD. | Larger systematic review (McCarty 2018) included. |
Rinsma NF, Smeets FG, Bruls DW et al. (2014) Effect of transoral incisionless fundoplication on reflux mechanisms. Surgical Endoscopy 28(3): 941–49. | RCT | Reduction in acid reflux by endoscopic fundoplication or PPI therapy leads to an increase in baseline impedance in GORD patients, likely to reflect recovery of mucosal integrity. The impact of non-acid reflux events on oesophageal mucosal integrity may be limited as no difference in the increase in baseline impedance was observed after both treatment options. The lack of association between impedance baseline and heartburn severity indicates that other factors may contribute to heartburn perception in GORD. | Results for endoscopic fundoplication and PPI therapy not reported separately. |
Robertson JO, Jarboe MD. (2018) Long-Term Outcomes of Transoral Incisionless Fundoplication in a High-Risk Pediatric Population. Journal of Laparoendoscopic & Advanced Surgical Techniques. 28(1): 95–100. | Case series | The recurrence rate was high, likely related to the fact that the population treated was extremely high risk. Recurrence was higher in patients with a prior fundoplication, perhaps identifying prior antireflux operations as a relative contraindication to TIF. Nevertheless, complications were low, and a subset of patients did receive a durable benefit from the procedure. | Studies with more patients or longer follow up are included. |
Snow GE, Dbouk M, Akst LM et al. (2021) Response of Laryngopharyngeal Symptoms to Transoral Incisionless Fundoplication in Patients with Refractory Proven Gastro-oesophageal Reflux. Annals of Otology, Rhinology and Laryngology 131(6):662-70 | Case series | In patients with objective evidence of GORD, TIF, or TIF with concomital hiatal hernia repair (cTIF) are safe and effective in controlling LPR symptoms as measured by normalization of RSI and improvement in patient satisfaction after TIF/cTIF. | Studies with more patients or longer follow up are included. |
Stefanidis G, Viazis N, Kotsikoros N et al. (2017) Long-term benefit of transoral incisionless fundoplication using the esophyx device for the management of gastro-oesophageal reflux disease responsive to medical therapy. Diseases of the Esophagus : Official Journal of the International Society for Diseases of the Esophagus 30(3): 1–8. | Case series | After a median follow up period of 59 months (36–75) the median GORD-HRQL scores improved significantly from 27 (2–45) at baseline to 4 (0–26) (P < 0.001) in the 44 patients completing the study. Heartburn was eliminated in 12 out of the 21 patients included (57.1%), regurgitation was eliminated in 15 out of the 17 patients included (88.2%) and chest pain was eliminated in 5 patients out of the six patients included (83.3%). Overall, 32 patients out of the 44 patients (72.7%) that completed the study follow up reported elimination of their main symptom, without the need for PPI administration (no PPI usage). Furthermore, six more patients (13.6%), five with heartburn, and one with regurgitation reported half PPI dose taken for <50% of the preceding follow up period (occasional PPI usage), while six more patients (four with heartburn, one with regurgitation, and one with chest pain) reported full or half PPI dose taken for more than 50% of the preceding follow up period (daily PPI usage). Creation of an esophagogastric fundoplication using the EsophyX device abolished reflux symptoms in 72.7% of PPI-responsive GORD patients at a median 59-month follow up. | Studies with more patients or longer follow up are included. |
Svoboda P, Kantorova I, Kozumplik L et al. (2011) Our experience with transoral incisionless plication of gastro-oesophageal reflux disease: NOTES procedure. Hepato-Gastroenterology 58(109): 1208–13. | RCT | It can be summarized that both NOTES TIF procedures with Esophyx and the Plicator are, after the initial learning curve, safe and effective methods for treatment of GORD, allowing substantial shortening of hospital stay. The effect of both procedures was sustained over 12 months. Longer follow up is necessary to verify efficacy for more years. | More recent studies are included. |
Testoni PA, Testoni S, Mazzoleni G et al. (2015) Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GORD patients followed for up to 6 years: a prospective single-center study. Surgical Endoscopy 29(9): 2770–80. | Case series | TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75–80 % of patients | A later version of the same study with longer follow up (Testoni 2019) is included. |
Testoni PA, Testoni S, Mazzoleni G et al. (2020) Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastro-oesophageal reflux disease: 12-month outcomes. Endoscopy 52(6): 469–73. | Case series | TIF with MUSE significantly improved symptoms at 1-year follow up, allowing the consumption of PPIs to be stopped or halved in 90% of patients. | Studies with more patients or longer follow up are included. |
Testoni PA, Vailati C, Testoni S et al. (2012) Transoral incisionless fundoplication (TIF 2.0) with EsophyX for gastro-oesophageal reflux disease: long-term results and findings affecting outcome. Surgical Endoscopy 26(5): 1425–35. | Case series | TIF using the EsophyX device allowed withdrawal or reduction of PPI in about 77% of patients at 6-month follow up and about 69% at 24 months. Larger number of fasteners deployed during TIF was predictive of positive outcome; pre-TIF ineffective oesophageal motility and hiatal hernia raised the risk of recurrence of GORD symptoms, but were not significant from a prospective point of view. | Studies with more patients or longer follow up are included. |
Testoni S, Hassan C, Antonelli G et al. (2021) Long-term outcomes of transoral incisionless fundoplication for gastro-oesophageal reflux disease: Systematic-review and meta-analysis. Endoscopy International Open 9(2): e239–46. | Systematic review and meta-analysis | TIF appears to offer a long-term safe therapeutic option for selected patients with GORD who refuse life-long medical therapy or surgery, are intolerant to PPIs, or are at increased surgical risk. | Larger systematic review (McCarty 2018) included. |
Toomey P, Teta A, Patel K et al. (2014) Transoral incisionless fundoplication: is it as safe and efficacious as a Nissen or Toupet fundoplication? The American Surgeon 80(9): 860–7. | Non-randomised comparative study | TIF leads to dramatic symptom resolution, similar when compared with Nissen or Toupet fundoplications. TIF promotes shorter operative times and lengths of stay. Patient satisfaction and effective palliation of symptoms show that TIF is safe and efficacious in comparison to Nissen and Toupet fundoplications and support its continued application and evaluation. | Larger studies or studies with longer follow up are included |
Trad KS, Barnes WE, Simoni G et al. (2015) Transoral incisionless fundoplication effective in eliminating GORD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial. Surgical Innovation 22(1): 26–40. | RCT (crossover) | At 6-month follow up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraoesophageal symptoms of GORD. | A later version of the same study with longer follow up (Trad 2018) is included. |
Trad KS, Fox MA, Simoni G et al. (2017) Transoral fundoplication offers durable symptom control for chronic GORD: 3-year report from the TEMPO randomized trial with a crossover arm. Surgical Endoscopy 31(6): 2498–2508. | RCT (crossover) | This study demonstrates that TIF can be used to | A later version of the same study with longer follow up (Trad 2018) is included. |
Trad KS, Turgeon DG, Deljkich E. (2012). Long-term outcomes after transoral incisionless fundoplication in patients with GORD and LPR symptoms. Surgical Endoscopy 26(3): 650–60. | Case series | Results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GORD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients. | Larger studies or studies with longer follow up are included |
Trad KS, Turgeon DG, Simoni G et al. (2014) Efficacy of transoral fundoplication for treatment of chronic gastro-oesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: A randomized, multicenter, open label, crossover study. BMC Gastroenterology 14(1): 174. | RCT (crossover) | The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TIF may provide further elimination of symptoms and oesophagitis healing. In the original TIF group, the clinical outcomes of TIF remained stable between 6- and 12-month follow up. | A later version of the same study with longer follow up (Trad 2018) is included. |
Weitzendorfer M, Spaun GO, Antoniou SA et al. (2017) Interim Report of a Prospective Trial on the Clinical Efficiency of a New Full-thickness Endoscopic Plication Device for Patients With GORD: Impact of Changed Suture Material. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 27(3): 163–9. | Case series | Endoscopic plication using the GORDx device may be effective in improving quality of life and GORD symptoms. Suture length between pledgets and suture material may have an impact on procedure outcomes. | Larger studies or studies with longer follow up are included |
Weitzendorfer M, Spaun GO, Antoniou SA et al. (2018) Clinical feasibility of a new full-thickness endoscopic plication device (GORDx TM) for patients with GORD: results of a prospective trial. Surgical Endoscopy 32(5): 2541–9. | Cohort study | Endoscopic plication with the GORDx™ device reduced distal acid exposure of the oesophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GORD. | Larger studies or studies with longer follow up are included |
Wendling MR, Melvin WS, Perry KA. (2013) Impact of transoral incisionless fundoplication (TIF) on subjective and objective GORD indices: a systematic review of the published literature. Surgical Endoscopy 27(10): 3754–61. | Systematic review and meta-analysis | TIF appears to provide symptomatic relief with reasonable levels of patient satisfaction at short-term follow up. A well-designed prospective clinical trial is needed to assess the effectiveness and durability of TIF as well as to identify the patient population that will benefit from this procedure. | Larger systematic review (McCarty 2018) included. |
Wilson EB, Barnes WE, Mavrelis PG et al. (2014) The effects of transoral incisionless fundoplication on chronic GORD patients: 12-month prospective multicenter experience. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 24(1): 36–46. | Case series | TIF provided a safe and effective therapeutic option | Larger studies or studies with longer follow up are included |
Witteman BPL, Conchillo JM, Rinsma NF et al. (2015) Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastro-oesophageal reflux disease. The American Journal of Gastroenterology 110(4): 531–42. | RCT | Although TIF resulted in an improved GORD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GORD patients, no long-term objective reflux control was achieved. | Larger studies or studies with longer follow up are included |
Witteman BPL, Strijkers R, Vries E de et al. (2012) Transoral incisionless fundoplication for treatment of gastro-oesophageal reflux disease in clinical practice. Surgical Endoscopy 26(11): 3307–15. | Case series | Endoluminal fundoplication improved quality of life and reduced the need for PPIs in only a subgroup of patients at 3 years follow up. The number of patients requiring additional medication and revisional surgery was high. | Larger studies or studies with longer follow up are included. |
Xie P, Yan J, Ye L et al. (2021) Efficacy of different endoscopic treatments in patients with gastro-oesophageal reflux disease: a systematic review and network meta-analysis. Surgical Endoscopy 35(4): 1500–1510. | Systematic review and meta-analysis | In terms of short-term reduction of the HRQL score and heartburn score in patients with GORD, TIF and Stretta may be comparable to each other, and both may be more effective than PPIs. TIF may increase the LES pressure in comparison with Stretta and PPIs. PPIs may reduce the percentage of time pH <4.0 when compared with TIF. This evidence should be interpreted with caution given the small number of included studies and inherent heterogeneity. | Larger systematic review (McCarty 2018) included. |
Zacherl J, Roy-Shapira A, Bonavina L et al. (2015) Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE TM) for gastro-oesophageal reflux disease: 6-month results from a multi-center prospective trial. Surgical Endoscopy 29(1): 220–29. | Case series | The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. | Larger studies or studies with longer follow up are included. |
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