Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study (FIS-1)
Drug: enteral nutrition
Drug: Parenteral nutrition
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective, Randomized Clinical Trial|
- The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Rates of fistula and treatment-related complications, changes in quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Drug: enteral nutrition
The research into field of the role of enteral nutrition in the treatment of pancreatic fistulas is fully justified by the lower cost and complications' rate of EN compared to PN observed in clinical trials comparing enteral and parnetral route of feeding in pre- and postoperative period. Such authors as Braga, Torosian, Lewis or Sand et al. proved that use of enteral nutrition led to smaller amount of complication (especially infectious) and improved the outcome of surgery. The only method to verify the role of enteral nutrition is the prospective, randomized clinical trial.
STUDY OBJECTIVES 2.1 Primary Objective The primary objective of this study is to evaluate the effectives of enteral nutrition in the treatment of pancreatic fistulas. The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure with the null hypothesis assuming that enteral nutrition provides better results than parenteral nutrition as far as the closure ratio, time to closure and treatment-related complications are concerned.
2.2 Secondary Objectives
The secondary objectives are to:
- determine time to fistula closure (defined as time between initiation of treatment and confirmed fistula closure),
- determine rates of fistula and treatment-related complications,
- assess changes in quality of life (QoL),
- determine economic costs of therapy. (for such terms as: fistula closure, time to closure see definition on page 3) For QoL assessment the EORTC QLQ - PAN26 score in Polish version (translation was approved by EORTC) will be used.
Benefits of the study:
- the implementation of safer and less expensive conservative procedure. Basis: Costs of enteral nutrition are significantly lower than PN and EN is significantly safer than PN especially as far as infectious complications are concerned.
- the enhancement of indications for enteral nutrition.
The confirmation of the null hypothesis allows recommending enteral nutrition as a method of choice for pancreatic fistula treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025414
|Nutrimed Medical Corporation|
|Krakow, Malopolska, Poland, 30-798|
|Principal Investigator:||Stanislaw Klek, MD PhD||Jagiellonian University|