Laparoscopic Reinforcement Suture (LARS) of Duodenal Stump A Prospective Single Arm Phase II Study

Not Applicable

• Conditions: Duodenal Stump Leak
• Interventions: Procedure: Laparoscopic reinforcement suture

• Registration Number: NCT03085199
• Lead Sponsor: Inje University

Brief Summary

Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted.

We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.

Detailed Description

As the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in Korea, Japan and China.

However, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. The incidence of duodenal stump leakage is reportedly between 1.6% to 5% in Billroth II or Roux en Y reconstruction after gastrectomy for gastric cancer. According to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach.

Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. I already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2017-03
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-15
• Last Update Submitted: 2017-03-15
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and B-II or Roux en Y reconstruction and age of above 19 years

Exclusion Criteria

• history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. And also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic reinforcement suture	Laparoscopic reinforcement suture	After cutting of duodenal stump of about 2 cm length using linear stapler, laparoscopic reinforcement suture commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures.

Primary Outcome Measures

Name	Time	Method
the incidence of duodenal stump fistula within postoperative 30 days	30 days	Duodenal stump fistula was defined as clinical suspicion, laboratory finding of fluid from drain or radiologic finding such as CT scan or fistulogram.

Trial Locations

Locations (1)

University of Inje College of Medicine, Haeundae Paik Hopsital; 🇰🇷 Busan, Korea, Republic of