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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Duodenal Stump Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Laparoscopic reinforcement suture

Intervention Type PROCEDURE

After cutting of duodenal stump of about 2 cm length using linear stapler, LARS 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.

Interventions

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Laparoscopic reinforcement suture

After cutting of duodenal stump of about 2 cm length using linear stapler, LARS 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No