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

Gastrointestinal Fistula Clinical Trial

— NUTRILEAK  

Official title:

Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03742752
• Other study ID #: 2016_74
• Secondary ID: 2018-A01625-50
• Status: Terminated
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: September 14, 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 % . 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Fistula
• Enteral Nutritional Support
• Fistula
• Gastrointestinal Fistula

Intervention

Other:
• Enteral nutrition
administration of enteral nutrition
• Parenteral nutrition
administration of parenteral nutrition

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-month fistula closure rate	Percentage of patients having their fistula closed according to the definition above within 6 months after randomization	at 6 months after randomization
Secondary	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	at 6 months after randomization
Secondary	Treatment-related complications	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)
Secondary	Postoperative mortality rate	rate of death after operation	at 30 days after randomization
Secondary	Postoperative morbidity rate	rate of patients with a Clavien-Dindo grade 3-4-5 complications	at 30 days after randomization
Secondary	Weight	in kg	longitudinal evaluation during all the study duration (from randomization to 6 months)
Secondary	Albumin and prealbumin	in g/L	longitudinal evaluation during all the study duration (from randomization to 6 months)
Secondary	C reactive protein	mg/L	longitudinal evaluation during all the study duration (from randomization to 6 months)
Secondary	Grip test	muscular strength	longitudinal evaluation during all the study duration (from randomization to 6 months)
Secondary	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	from the randomization until the end of hospitalization, up to 6 months
Secondary	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.	at inclusion, day 30, day 60, 3 months and 6 months