NCT03085199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

March 15, 2017

Last Update Submit

March 15, 2017

Conditions

Duodenal Stump Leak

Keywords

gastric cancerlaparoscopic gastrectomylaparoscopic reinforcement suture (LARS)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Laparoscopic reinforcement suture

OTHER

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.

Procedure: Laparoscopic reinforcement suture

Interventions

Laparoscopic reinforcement suturePROCEDURE

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.

Laparoscopic reinforcement suture

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Inje College of Medicine, Haeundae Paik Hopsital

Busan, 612-030, South Korea

RECRUITING

Related 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. Epub 2016 Mar 31.

    PMID: 27104024RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • kwan woo kim, phd

    Dong-A University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kwan woo kim, phd

CONTACT

82-51-240-2905d002045@gmail.com

min chan kim, phd

CONTACT

82-51-240-2643mckim@dau.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 21, 2017

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)