Gastrointestinal FistulaNUTRILEAKNCT03742752
Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery
A study testing Enteral nutrition and Parenteral nutrition in people with Gastrointestinal Fistula and Enteral Nutritional Support, run by University Hospital, Lille at 1 site in France.
Trial 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 % . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Fistula, Enteral Nutritional Support
- What is being tested?
- Enteral nutrition and Parenteral nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2019to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label
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 .
Read more
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.
- Being tested
- Enteral nutrition, Parenteral nutrition
- Keywords
- enteral nutrition, parenteral nutrition, gastrointestinal fistula
- Medical subject headings
- Digestive System Fistula, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutritionOther
administration of enteral nutrition
Parenteral nutritionOther
administration of parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition (EN) | Experimental | To demonstrate the superiority of EN versus TPN in the treatment of postoperative upper GI anastomotic leak (PUGIAL) after upper GI surgery (including esophageal, gastric, duodenal, pancreatic and obesity surgery).
Patients will be randomized to receive EN through jejunostomy or nasojejunal tube until oral diet covering at least 60% of their daily requirement Receives: Other: Enteral nutrition |
| Parenteral Nutrition (TPN) | Active comparator | Patients will be randomized to receive TPN through central venous access, piccline or totally implantable venous access port tube until oral diet covering at least 60% of their daily requirement Receives: Other: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day fistula closure rate
Fistula closure will be defined as an output of no fluid for at least 48 hours in wound or drainage AND absence of any fluid collection on imaging (Computed Tomography scan with injection of contrast product).
Measured: 30 days after randomization
Secondary outcomes (11)
6-month fistula closure rate
Percentage of patients having their fistula closed according to the definition above within 6 months after randomization
Measured: at 6 months after randomization
Time to first fistula closure
Time to first fistula closure defined as time in days from randomization to first AL closure within 6 months after randomization
Measured: at 6 months after randomization
Treatment-related complications
number of patients presenting at least one complication related to the nutritional support (catheter related infection or thrombosis, tube related complication)
Measured: longitudinal evaluation during all the study duration (from randomization to 6 months)
Postoperative mortality rate
rate of death after operation
Measured: at 30 days after randomization
Postoperative morbidity rate
rate of patients with a Clavien-Dindo grade 3-4-5 complications
Measured: at 30 days after randomization
Weight
in kg
Measured: longitudinal evaluation during all the study duration (from randomization to 6 months)
Albumin and prealbumin
in g/L
Measured: longitudinal evaluation during all the study duration (from randomization to 6 months)
C reactive protein
mg/L
Measured: longitudinal evaluation during all the study duration (from randomization to 6 months)
Grip test
muscular strength
Measured: longitudinal evaluation during all the study duration (from randomization to 6 months)
Length of hospital stay in healthcare structure
Length of hospital stay in healthcare structure (including home hospitalization) based on the number of days of hospitalization
Measured: from the randomization until the end of hospitalization, up to 6 months
Short form questionnaire 36 (SF-36)
Patient's Health-related quality of life (HRQOL) score. The SF-36 includes a single-item measure of health transition or change. he SF-36® Health Survey items and scales were constructed using the Likert method of summated ratings.4 Answers to each question are scored (some items need to be recoded). These scores are then summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale. Thie higher the score is, the better the quality of life is.
Measured: at inclusion, day 30, day 60, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start7 Jun 2019
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Why it stopped: default inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal FistulaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Piessen, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742752
- Sponsor's protocol ID
- 2016_74
- Other IDs
- 2018-A01625-50
- Acronym
- NUTRILEAK
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gronnier C, Chambrier C, Duhamel A, Dervaux B, Collet D, Vaudoyer D, Regimbeau JM, Jougon J, Thereaux J, Lebreton G, Veziant J, Valverde A, Ortega-Deballon P, Pattou F, Mathonnet M, Perinel J, Beyer-Berjot L, Fuks D, Rouanet P, Lefevre JH, Cattan P, Deguelte S, Meunier B, Tuech JJ, Pessaux P, Carrere N, Salame E, Benaim E, Dousset B, Msika S, Mariette C, Piessen G; FRENCH association. Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study). Trials. 2020 Jun 2;21(1):448. doi: 10.1186/s13063-020-04366-3.
PubMed 32487210
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label
- ClinicalTrials.gov ID
- NCT03742752
- Acronym / sponsor ID
- NUTRILEAK / 2016_74
- Keywords
- enteral nutrition, parenteral nutrition, gastrointestinal fistula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: default inclusion
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition (EN) | Experimental | Other: Enteral nutritionTo demonstrate the superiority of EN versus TPN in the treatment of postoperative upper GI anastomotic leak (PUGIAL) after upper GI surgery (including esophageal, gastric, duodenal, pancreatic and obesity surgery). Patients will be randomized to receive EN through jejunostomy or nasojejunal tube until oral diet covering at least 60% of their daily requirement |
| Parenteral Nutrition (TPN) | Active comparator | Other: Parenteral nutritionPatients will be randomized to receive TPN through central venous access, piccline or totally implantable venous access port tube until oral diet covering at least 60% of their daily requirement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral nutritionadministration of enteral nutrition | Other | Enteral Nutrition (EN) |
| Parenteral nutritionadministration of parenteral nutrition | Other | Parenteral Nutrition (TPN) |
Primary outcome
30-day fistula closure rate
Time frame: 30 days after randomization
Fistula closure will be defined as an output of no fluid for at least 48 hours in wound or drainage AND absence of any fluid collection on imaging (Computed Tomography scan with injection of contrast product).
11 secondary outcomes
6-month fistula closure rate
Time frame: at 6 months after randomization
Time to first fistula closure
Time frame: at 6 months after randomization
Treatment-related complications
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Postoperative mortality rate
Time frame: at 30 days after randomization
Postoperative morbidity rate
Time frame: at 30 days after randomization
Weight
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Albumin and prealbumin
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
C reactive protein
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Grip test
Time frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
Length of hospital stay in healthcare structure
Time frame: from the randomization until the end of hospitalization, up to 6 months
Short form questionnaire 36 (SF-36)
Time frame: at inclusion, day 30, day 60, 3 months and 6 months
Results and safety
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 32487210Gronnier C, Chambrier C, Duhamel A, Dervaux B, Collet D, Vaudoyer D, Regimbeau JM, Jougon J, Thereaux J, Lebreton G, Veziant J, Valverde A, Ortega-Deballon P, Pattou F, Mathonnet M, Perinel J, Beyer-Berjot L, Fuks D, Rouanet P, Lefevre JH, Cattan P, Deguelte S, Meunier B, Tuech JJ, Pessaux P, Carrere N, Salame E, Benaim E, Dousset B, Msika S, Mariette C, Piessen G; FRENCH association. Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study). Trials. 2020 Jun 2;21(1):448. doi: 10.1186/s13063-020-04366-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Piessen, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition and Parenteral nutrition in people with Gastrointestinal Fistula and Enteral Nutritional Support, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: default inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day fistula closure rate (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03742752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.