Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Overview

– 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.

Full Title of Study: “Randomized Controlled Trial on Surgical Safety of Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Procedure: Intracorporeal Roux-en-Y esophagojejunostomy
    • During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
  • Procedure: Extracorporeal Roux-en-Y esophagojejunostomy
    • During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.

Arms, Groups and Cohorts

  • Experimental: Intracorporeal Roux-en-Y esophagojejunostomy
    • 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.
  • Active Comparator: Extracorporeal Roux-en-Y esophagojejunostomy
    • During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed for the patients assigned to this arm.

Clinical Trial Outcome Measures

Primary Measures

  • Anastomosis-related early complication rate
    • Time Frame: 30 days
    • Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.

Secondary Measures

  • Reconstruction time
    • Time Frame: During operation
    • Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed. Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed.
  • Morbidity and mortality rates
    • Time Frame: 30 days
    • The early postoperative complication was defined as the event observed within 30 days after surgery.
  • Postoperative recovery course
    • Time Frame: 2 weeks
    • Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course.
  • Postoperative quality of life
    • Time Frame: 6 months
    • EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanfang Hospital of Southern Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guoxin Li, M.D., Ph.D. – Nanfang Hospital of Southern Medical University
  • Overall Official(s)
    • Guoxin Li, M.D., Ph.D., Principal Investigator, Nanfang Hospital, Southern Medical University, China
  • Overall Contact(s)
    • Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com

References

Marangoni 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.

Jeong 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.

Kunisaki 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.

Jeong 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.

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