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

NCT03742752 | Terminated

• 2 other identifiers: 2016_742018-A01625-50
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Nutritional Support; Gastrointestinal Fistula

Keywords

enteral nutrition; parenteral nutrition; gastrointestinal fistula

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days after randomization

Secondary Outcomes (11)

• 6-month fistula closure rate

  at 6 months after randomization

• Time to first fistula closure

  at 6 months after randomization

• Treatment-related complications

  longitudinal evaluation during all the study duration (from randomization to 6 months)

• Postoperative mortality rate

  at 30 days after randomization

• Postoperative morbidity rate

  at 30 days after randomization

Study Arms (2)

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

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

Other: Parenteral nutrition

Interventions

Enteral nutrition OTHER

administration of enteral nutrition

Enteral Nutrition (EN)

Parenteral nutrition OTHER

administration of parenteral nutrition

Parenteral Nutrition (TPN)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 32487210 BACKGROUND

MeSH Terms

Conditions

Digestive System Fistula; Hyperphagia

Interventions

Enteral Nutrition; Parenteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Guillaume Piessen, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 15, 2018
• Study Start: June 7, 2019
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)