Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery (NUTRILEAK)

October 14, 2022 updated by: University Hospital, Lille

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 .

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral Nutrition (EN)

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
Other: Enteral nutrition
administration of enteral nutrition
Active Comparator: Parenteral Nutrition (TPN)
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
Other: Parenteral nutrition
administration of parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
30 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month fistula closure rate
Time Frame: at 6 months after randomization
Percentage of patients having their fistula closed according to the definition above within 6 months after randomization
at 6 months after randomization
Time to first fistula closure
Time Frame: at 6 months after randomization
Time to first fistula closure defined as time in days from randomization to first AL closure within 6 months after randomization
at 6 months after randomization
Treatment-related complications
Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
number of patients presenting at least one complication related to the nutritional support (catheter related infection or thrombosis, tube related complication)
longitudinal evaluation during all the study duration (from randomization to 6 months)
Postoperative mortality rate
Time Frame: at 30 days after randomization
rate of death after operation
at 30 days after randomization
Postoperative morbidity rate
Time Frame: at 30 days after randomization
rate of patients with a Clavien-Dindo grade 3-4-5 complications
at 30 days after randomization
Weight
Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months)
in kg
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)
in g/L
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)
mg/L
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)
muscular strength
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
Length of hospital stay in healthcare structure (including home hospitalization) based on the number of days of hospitalization
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
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.
at inclusion, day 30, day 60, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2019

Primary Completion (Actual)

September 14, 2021

Study Completion (Actual)

September 14, 2021

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_74
  • 2018-A01625-50 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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