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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03277144 -
Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial
|
N/A |