– 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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
- 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
- Anastomosis-related early complication rate
- Time Frame: 30 days
- Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication.
- 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
- 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
- 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, firstname.lastname@example.org
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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.
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