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

Phase 2

• Conditions: Minimally Invasive Surgery; Stomach Neoplasms; Anastomosis
• Interventions: Procedure: Intracorporeal Roux-en-Y esophagojejunostomy; Procedure: Extracorporeal Roux-en-Y esophagojejunostomy

• Registration Number: NCT02085031
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Status Verified: 2014-04
• Study Start: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracorporeal Roux-en-Y esophagojejunostomy	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.
Extracorporeal Roux-en-Y esophagojejunostomy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reconstruction time	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	30 days	The early postoperative complication was defined as the event observed within 30 days after surgery.
Postoperative recovery course	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	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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China