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

Duodenal Stump Leak Clinical Trial

Official title:

Laparoscopic Reinforcement Suture (LARS) on Staple-line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Single Arm Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085199
• Other study ID #: DAUHIRB-16-010
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2017
• Last updated: March 15, 2017
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Inje University
• Contact: kwan woo kim, phd
• Phone: 82-51-240-2905
• Email: d002045[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Stump Leak

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	University of Inje College of Medicine, Haeundae Paik Hopsital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ali BI, Park CH, Song KY. Outcomes of Non-Operative Treatment for Duodenal Stump Leakage after Gastrectomy in Patients with Gastric Cancer. J Gastric Cancer. 2016 Mar;16(1):28-33. doi: 10.5230/jgc.2016.16.1.28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of duodenal stump fistula within postoperative 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.	30 days