Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03742752
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Fistula Enteral Nutritional Support Other: Enteral nutrition Other: Parenteral nutrition Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. Postoperative mortality rate [ Time Frame: at 30 days after randomization ]
    rate of death after operation

  5. Postoperative morbidity rate [ Time Frame: at 30 days after randomization ]
    rate of patients with a Clavien-Dindo grade 3-4-5 complications

  6. Weight [ Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months) ]
    in kg

  7. Albumin and prealbumin [ Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months) ]
    in g/L

  8. C reactive protein [ Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months) ]
    mg/L

  9. Grip test [ Time Frame: longitudinal evaluation during all the study duration (from randomization to 6 months) ]
    muscular strength

  10. 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

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Peritoneal carcinomatosis or distant metastasis
  • Pregnant and/or lactating women
  • Freedom privacy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742752


Contacts
Layout table for location contacts
Contact: Guillaume Piessen, MD,PhD 3 20 44 44 07 ext +33 guillaume.piessen@chru-lille.fr
Contact: Caroline Gronnier, MD caroline.gronnier@hotmail.fr

Locations
Layout table for location information
France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Principal Investigator: Guillaume Piessen, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Layout table for investigator information
Principal Investigator: Guillaume Piessen, MD,PhD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03742752     History of Changes
Other Study ID Numbers: 2016_74
2018-A01625-50 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
enteral nutrition
parenteral nutrition
gastrointestinal fistula

Additional relevant MeSH terms:
Layout table for MeSH terms
Fistula
Digestive System Fistula
Pathological Conditions, Anatomical
Digestive System Diseases