UnknownNot Applicable

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

Italy700 participantsStarted 2017-09-11

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pathologically proven malign tumor of the stomach * age of 18 to 80 years, * no history of other cancers * no history of radiotherapy in supra-mesocolic space * total or distal gastrectomy without anastomosis with the duodenum Exclusion Criteria: * emergency surgery * American Society of Anesthesiologists class \> 3 * need for combined resection of other organs * laparoscopic/robotic access * severe heart disease * liver cirrhosis * T stage \>cT4a * citology positive at preoperative laparoscopy * cM+ (clinical suspicion of distant metastasis) * cD+ (clinical suspicion of duodenal involvment)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

incidence of duodenal stump leak

Timeframe: within 30/60 days from operation

Trial details

NCT IDNCT03277144

SponsorUniversity of Turin, Italy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-11

Contact for this trial

Rossella Reddavid, MD

+393479848651 rossella.reddavid@gmail.com

View on ClinicalTrials.gov More Gastric Cancer trials