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

NCT ID: NCT03742752

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-07
• Study Completion Date: 2021-09-14

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

Gastrointestinal Fistula; Enteral Nutritional Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Enteral nutrition

Intervention Type: OTHER

administration of enteral nutrition

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

Group Type: ACTIVE_COMPARATOR

Parenteral nutrition

Intervention Type: OTHER

administration of parenteral nutrition

Interventions

Enteral nutrition

administration of enteral nutrition

Intervention Type: OTHER

Parenteral nutrition

administration of parenteral nutrition

Intervention Type: OTHER

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Piessen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Claude Huriez, CHU

Lille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32487210 (View on PubMed)

Other Identifiers

2018-A01625-50

Identifier Type: OTHER

Identifier Source: secondary_id

2016_74

Identifier Type: -

Identifier Source: org_study_id