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Transoral outlet reduction

From EverybodyWiki Bios & Wiki




Transoral outlet reduction
Other namesTORe; endoscopic gastrojejunal anastomosis reduction
SpecialtyBariatrics, Gastroenterology
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Transoral outlet reduction (TORe) is a minimally invasive endoscopic revision procedure used to treat weight regain and dumping syndrome in patients who have previously undergone Roux-en-Y gastric bypass (RYGB).[1][2] The procedure narrows a dilated gastrojejunal anastomosis — the surgically created connection between the gastric pouch and the jejunum — using full-thickness endoscopic sutures placed through the mouth, without external incisions.[3]

TORe was developed by Christopher C. Thompson, a gastroenterologist at Brigham and Women's Hospital, Harvard Medical School professor, and co-founder of Everself, who first described peroral endoscopic reduction of the dilated gastrojejunal anastomosis in 2006.[4][1][5] A multicenter randomized, sham-controlled trial (the RESTORe trial) published in Gastroenterology in 2013 established the procedure's efficacy.[3] In July 2022, the U.S. Food and Drug Administration granted De Novo marketing authorization to the Apollo REVISE system specifically for performing TORe.[6][7]

Medical uses

TORe is indicated for adults with prior Roux-en-Y gastric bypass who experience clinically significant weight regain in the setting of a dilated gastrojejunal anastomosis (commonly defined as a diameter greater than approximately 15–20 mm).[2] A dilated outlet is associated with accelerated gastric emptying, reduced satiety, and weight regain.[3]

The procedure is also used to treat late-onset dumping syndrome refractory to dietary and medical therapy after RYGB, by slowing the transit of food from the gastric pouch into the small intestine.[2]

Technique

TORe is performed under general anesthesia as an outpatient procedure, typically lasting less than one hour.[1] A flexible endoscope is advanced through the mouth into the gastric pouch. The mucosal rim of the gastrojejunal anastomosis is first ablated using argon plasma coagulation to promote tissue adhesion.[2] A full-thickness endoscopic suturing device — historically the Apollo OverStitch (Apollo Endosurgery), and since 2022 the FDA-authorized Apollo REVISE system — is then used to place sutures around the outlet.[6]

Two principal stitch configurations have been described: an interrupted pattern, in which multiple individual sutures are placed circumferentially, and a purse-string pattern, in which a single running suture is cinched to create concentric narrowing.[8] The purse-string technique has been associated with greater and more durable weight loss in comparative studies.[8]

Outcomes

TORe was first described by Thompson and colleagues in a 2006 pilot series, which established the technical feasibility of peroral endoscopic reduction of the dilated gastrojejunal anastomosis in patients with weight regain after Roux-en-Y gastric bypass.[4] The pivotal multicenter, randomized, double-blind, sham-controlled RESTORe trial, published in Gastroenterology in 2013, enrolled 77 patients across eight U.S. academic centers and demonstrated that TORe with full-thickness endoscopic suturing produced statistically significantly greater weight loss than a sham endoscopic procedure at 6 months, establishing the first level-I evidence for endoscopic revision of gastric bypass.[3]

Suturing pattern

A 2025 Association for Bariatric Endoscopy systematic review and meta-analysis evaluating TORe against the American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) thresholds found that the purse-string suture pattern produced significantly greater weight loss than other suture configurations, with a pooled mean total body weight loss of 12.8% at 12 months across 5 studies and 687 patients (95% CI, 7.8%–17.8%). The pooled serious adverse event rate across the broader meta-analysis was 1.5%, meeting the PIVI safety threshold.[9]

A large community-practice cohort of 284 adults undergoing TORe for weight recurrence after RYGB, published in World Journal of Gastrointestinal Endoscopy in 2023, reported a mean total body weight loss of 17.3% at 12 months, with 81.2% of patients achieving ≥10% total body weight loss.[10]

Enhanced techniques

Two technique refinements have produced substantially greater weight loss than the average across earlier TORe series:

  • ESD-TORe replaces argon plasma coagulation with endoscopic submucosal dissection of the anastomotic rim prior to suturing, exposing the submucosa and allowing deeper, more durable tissue apposition. In a matched-cohort study published in Gastrointestinal Endoscopy in 2020 by Jirapinyo, Thompson and colleagues, ESD-TORe produced a mean total body weight loss of 13.4% at 6 months and 12.1% at 12 months.[11] Earlier work by Galvao Neto and colleagues describing a modified-ESD plus APC and suturing technique was published in Obesity Surgery in 2019.[12]
  • TORe with adjunctive anti-obesity medication (AOM). Initiation of an AOM — such as topiramate, phentermine/topiramate, or liraglutide — within 6 months of TORe produced a mean total body weight loss of 15.2% at 12 months, superior to either intervention alone and comparable to surgical revision.[13]

A 2023 systematic review also concluded that TORe is effective for treating dumping syndrome after RYGB, with most patients experiencing improvement in symptom scores after the procedure.[2]

Adverse events

TORe has a favorable safety profile. Reported adverse events are predominantly mild and self-limiting, including post-procedural nausea, vomiting, and epigastric pain.[3] Serious adverse events such as bleeding, perforation, or stenosis of the outlet are rare in published series.[2]

History

Endoscopic suturing for revision of gastric bypass was first performed in 2004, with the first peer-reviewed pilot series of peroral endoscopic gastrojejunal anastomotic reduction published by Thompson and colleagues at Brigham and Women's Hospital in 2006.[4][14] The introduction of full-thickness endoscopic suturing — particularly the Apollo OverStitch system, which received 510(k) clearance from the FDA in 2008 — enabled a reproducible, durable technique.[15][14]

In 2013, the RESTORe trial provided the first level-I evidence for the procedure.[3] In July 2022, the FDA granted De Novo marketing authorization to the Apollo REVISE and Apollo REVISE Sx systems, the first devices specifically cleared in the United States for endoscopic bariatric revision via TORe.[6][7]

Thompson, who developed and patented the technique, subsequently co-founded the endoscopic weight-care provider Everself (formerly Bariendo), which offers TORe — including the ESD-TORe variant — at its U.S. clinics.[5][16]

See also

References

  1. 1.0 1.1 1.2 "Transoral Outlet Reduction (TORe)". Brigham and Women's Hospital, Center for Weight Management and Wellness. Retrieved 2026-05-30.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 Jirapinyo, Pichamol; Thompson, Christopher C. (2023). "Transoral Outlet Reduction (TORe) for the Treatment of Weight Regain and Dumping Syndrome after Roux-en-Y Gastric Bypass". Current Obesity Reports. 12 (1): 83–94. doi:10.1007/s13679-023-00499-z. PMC 9865659 Check |pmc= value (help). PMID 36633812 Check |pmid= value (help).
  3. 3.0 3.1 3.2 3.3 3.4 3.5 Thompson, Christopher C.; Chand, Bipan; Chen, Yang K.; Demarco, Daniel C.; Miller, Larry; Schweitzer, Michael; Rothstein, Richard I.; Lautz, David B.; Slattery, Jeffrey; Ryan, Michele B.; Brethauer, Stacy; Schauer, Philip; Mitchell, Marc T.; Starpoli, Anthony; Haber, Gregory B.; Catalano, Marc F.; Edmundowicz, Steven; Fanelli, Robert D.; Hawes, Robert; Gostout, Christopher J. (July 2013). "Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery". Gastroenterology. 145 (1): 129–137.e3. doi:10.1053/j.gastro.2013.04.002. PMID 23567348.
  4. 4.0 4.1 4.2 Thompson, Christopher C.; Slattery, J.; Bundga, M. E.; Lautz, D. B. (November 2006). "Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain". Surgical Endoscopy. 20 (11): 1744–1748. doi:10.1007/s00464-006-0045-0. PMID 17024527.
  5. 5.0 5.1 "Dr. Christopher C. Thompson, MD MSc FASGE FACG AGAF". Everself. Retrieved 2026-05-30.
  6. 6.0 6.1 6.2 "DEN210045 — De Novo Classification Decision Summary" (PDF). U.S. Food and Drug Administration. 2022. Retrieved 2026-05-30.
  7. 7.0 7.1 "FDA grants de novo clearance for endoscopic sleeve gastroplasty, bariatric revision devices". Healio Gastroenterology. July 15, 2022. Retrieved 2026-05-30.
  8. 8.0 8.1 Jirapinyo, Pichamol; de Moura, Diogo Turiani Hourneaux; Thompson, Christopher C. (March 2018). "Transoral outlet reduction: a comparison of purse-string with interrupted stitch technique". Gastrointestinal Endoscopy. 87 (3): 786–792. doi:10.1016/j.gie.2017.10.034. PMC 5899924. PMID 29108984.
  9. Jirapinyo, Pichamol; Watson, Rabindra R.; Aihara, Hiroyuki; Bhatt, Amit; Bilal, Mohammad; Hwang, Joo Ha; Mishra, Girish; Sharma, Neil R.; Trindade, Arvind J.; Yang, Juliana; Lichtenstein, David R.; et al. (2025). "Association for Bariatric Endoscopy systematic review and meta-analysis assessing the American Society for Gastrointestinal Endoscopy preservation and incorporation of valuable endoscopic innovations thresholds for transoral outlet reduction". Gastrointestinal Endoscopy. 102 (4): 440–453.e6. doi:10.1016/j.gie.2025.06.039. PMID 40711436 Check |pmid= value (help).
  10. Deng, John; Blanco Montecino, Ronald; Ellis, Daniel J.; Tavakkoli, Anna (2023). "Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice". World Journal of Gastrointestinal Endoscopy. 15 (10): 602–610. doi:10.4253/wjge.v15.i10.602. PMC 10600692 Check |pmc= value (help). PMID 37900116 Check |pmid= value (help).
  11. Jirapinyo, Pichamol; Kumar, Nitin; Saumoy, Monica; Wang, Jenny Y.; AlSamman, Mohd A.; Thompson, Christopher C. (May 2020). "Endoscopic submucosal dissection with suturing for the treatment of weight regain after gastric bypass: outcomes and comparison with traditional transoral outlet reduction (with video)". Gastrointestinal Endoscopy. 91 (5): 1024–1032. doi:10.1016/j.gie.2019.12.029. PMC 7245570 Check |pmc= value (help). PMID 32007520 Check |pmid= value (help).
  12. Galvao Neto, Manoel; de Quadros, Luiz Gustavo; Grecco, Eduardo; Filho, Almino Cardoso Ramos; Souza, Thiago Ferreira; Marchetti, Igor Andrade; Mota, Eduardo Lemos; Marchesini, João Caetano; Zundel, Natan (July 2019). "Modified-ESD Plus APC and Suturing for Treatment of Weight Regain After Gastric Bypass: Feasibility and Short-Term Outcome". Obesity Surgery. 29 (7): 2189–2194. doi:10.1007/s11695-019-03808-5. PMID 30937873.
  13. Jirapinyo, Pichamol; Thompson, Christopher C. (2023). "Comparison of transoral outlet reduction with the addition of anti-obesity medications versus either intervention alone for weight regain after Roux-en-Y gastric bypass". Gastrointestinal Endoscopy. 98 (4): 540–548. doi:10.1016/j.gie.2023.04.2080. PMID 37150416 Check |pmid= value (help).
  14. 14.0 14.1 Kumar, Nitin; Abu Dayyeh, Barham K.; Lopez-Nava Breviere, Gontrand; Galvao Neto, Manoel P.; Sahdala, Nicole P.; Shaikh, Sohail N.; Hawes, Robert H.; Gostout, Christopher J.; Goenka, Mahesh K.; Orillac, Jorge R.; Alvarado, Alonso; Jirapinyo, Pichamol; Zundel, Natan; Thompson, Christopher C. (2018). "Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique". Surgical Endoscopy. 32 (4): 2159–2164. doi:10.1007/s00464-017-5869-2. PMC 5845469. PMID 29075966.
  15. "Apollo Endosurgery, Inc. Announces 510(k) Clearance for Its Flexible Endoscopic Suturing System". BioSpace. October 2, 2008. Retrieved 2026-05-30.
  16. "Gastric Bypass Revision". Everself. Retrieved 2026-05-30.

External links

Template:Bariatrics

Category:Bariatric surgery Category:Endoscopy


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