Feeding through a tube vs. vein: which heals gut leaks faster?
NCT ID NCT03742752
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compared two ways of feeding patients who developed a leak (fistula) after upper gastrointestinal surgery: feeding through a tube into the gut (enteral nutrition) versus feeding through a vein (parenteral nutrition). The goal was to see if enteral nutrition could help close the leak faster. The trial was stopped early after enrolling only 6 people, so no strong conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enteral nutrition and parenteral nutrition
- What this could lead to
- If successful, this could show that enteral nutrition helps close fistulas faster than parenteral nutrition, improving recovery after upper GI surgery.
- What could go wrong
- The trial was terminated early with only 6 participants, so results are very limited. It is unclear if enteral nutrition is truly better, and more research is needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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6 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Sep 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ≥ 18 years * Patients having received upper GI surgery for benign or malignant disease including, oesophageal, gastric, duodenal or pancreatic surgery or bariatric surgery * Diagnosis of an active postoperative fistula or persisting after a failure of surgical or endoscopic procedure dedicated to close the fistula * AL diagnosed from less than 72h AND confirmed on at least two criteria among the followings: * clinical symptoms of AL * ct scan / ultrason imaging and /or endoscopic diagnosis of AL * biologic/bacteriology diagnosis on fluid output * intraoperative diagnosis of AL at time of reoperation * Indication of nil per mouth * American society of anesthesiologist score 1, 2 or 3 * In case of neoplasm, absence of peritoneal carcinomatosis or distant metastasis * No severe concomitant uncontrolled disease * Life expectancy more than 6 months * No history of allergy or study product intolerance * Ongoing healthcare insurance Exclusion Criteria: * \- Scheduled surgical or endoscopic treatment with the aim to close the fistula (suture, prosthesis, clip or glue). In case of such treatment failure, patients are eligible to participate to the study. Endoscopic or surgical drainage are not exclusion criteria (meaning that drainage only is authorized before randomization) * History of or current severe uncontrolled cardiovascular, pulmonary, renal or liver failure * Uncontrolled sepsis related to the AL * Malnutrition requiring combined nutritional treatment with the enteral AND parenteral routes together * Untreated or persistent Peritoneal carcinomatosis or distant metastasis * Pregnant and/or lactating women * Freedom privacy
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Claude Huriez, CHU
Lille, France
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