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Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial

NCT03277144 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2017-09-18

No results posted yet for this study

Summary

The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal resection during open gastrectomy for cancer is safer than the use of other conventional methods of resection/closure of the duodenum and that the incidence of duodenal fistula can be decreased to that observed after the use of this technology in Laparoscopic and robotic gastrectomy, therefore almost three times lower than that currently reported in literature.

Participating centres must have an annual volume of at least 20 gastrectomies per year.

Conditions

Interventions

DEVICE

TST-TriStaple(3lines stapler)Technology

Duodenal stump closed using a Tristaple ( three-lines linear stapler) device

OTHER

other conventional techniques

Duodenal stump closed using other conventional techniques entailing manual suture or mechanical devices with only two lines of sutures.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Maurizio Degiuli, MD Prof · University of Turin, San Luigi University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2018-09-11
Completion
2019-10-01
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277144 on ClinicalTrials.gov