Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistu… (NCT03742752) | Clinical Trial Compass
TerminatedNot Applicable
Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery
Stopped: default inclusion
France6 participantsStarted 2019-06-07
Plain-language summary
The incidence of clinically significant anastomotic leaks (AL) after upper gastrointestinal (GI) surgery is approximately 4 % - 20 %, and the associated mortality can be as high as 80 % . Nutritional support is a key component of therapy in such cases, related to high prevalence of malnutrition and nil per month required for leak treatment.
In the prophylactic setting, before the occurrence of any AL, a literature review based on seven randomised trials showed that enteral nutrition (EN) is associated with shorter hospital stay, lower incidence of severe of infectious complications, lower severity of complications and decreased cost compared to parenteral nutrition (TPN) following major upper GI surgery .
In the curative setting, after the AL occurrence, very few evidence is available. Only one randomized clinical trial suggested the superiority of EN versus TPN after pancreatic surgery with a increase of the 30-day fistula closure rate from 37% in the TPN group to 60% in the EN group .
This sole randomised study available did not include all postoperative upper GI AL (PUGIAL) that can occur after esophageal, gastric, duodenal, pancreatic surgery (including obesity surgery), whereas the concept of enteral nutritional support is highly relevant for all these situations.
However surgeons are usually reluctant to provide EN in case of AL. A randomized study suggested the feasibility of EN in 47 patients with upper GI AL but no randomized study to date has been designed to test the superiority of EN versus TPN in PUGIAL.
The study aim is to demonstrate the superiority of EN versus TPN to accelerate AL healing after upper GI surgery.
Hypothesis:
EN increases the 30-day fistula closure rate in PUGIAL, allowing better HRQOL without increasing morbi-mortality.
Who can participate
Age range
18 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:
* 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…
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.