Clinical trial · Interventional
Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed. * To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently. * However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomosis | — | UNRESOLVED | — |
| Minimally Invasive Surgery | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracorporeal Roux-en-Y esophagojejunostomy | Procedure | — | UNRESOLVED |
| Intracorporeal Roux-en-Y esophagojejunostomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intracorporeal Roux-en-Y esophagojejunostomy
- description
- During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed for the patients assigned to this arm.
- interventionNames
- Procedure: Intracorporeal Roux-en-Y esophagojejunostomy
- type
- ACTIVE_COMPARATOR
- label
- Extracorporeal Roux-en-Y esophagojejunostomy
- description
- During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm.
- interventionNames
- Procedure: Extracorporeal Roux-en-Y esophagojejunostomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Age from over 18 to under 75 years * Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy * Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery * Tumor invasion is less than 3cm above the esophagogastric junction * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) score class I, II, or III * Written informed consent Exclusion Criteria: * Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * Conversion to open surgery before reconstruction
References
Publications (4)
- BACKGROUNDMarangoni G, Villa F, Shamil E, Botha AJ. OrVil-assisted anastomosis in laparoscopic upper gastrointestinal surgery: friend of the laparoscopic surgeon. Surg Endosc. 2012 Mar;26(3):811-7. doi: 10.1007/s00464-011-1957-x. Epub 2011 Oct 13. PMID 21993942
- BACKGROUNDJeong O, Park YK. Intracorporeal circular stapling esophagojejunostomy using the transorally inserted anvil (OrVil) after laparoscopic total gastrectomy. Surg Endosc. 2009 Nov;23(11):2624-30. doi: 10.1007/s00464-009-0461-z. Epub 2009 Apr 3. PMID 19343421
- BACKGROUNDKunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17. PMID 20953884
- BACKGROUNDJeong O, Jung MR, Kim GY, Kim HS, Ryu SY, Park YK. Comparison of short-term surgical outcomes between laparoscopic and open total gastrectomy for gastric carcinoma: case-control study using propensity score matching method. J Am Coll Surg. 2013 Feb;216(2):184-91. doi: 10.1016/j.jamcollsurg.2012.10.014. Epub 2012 Dec 2. PMID 23211117