Pancreatic Fistula Clinical Trial
Official title:
The Use of Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective, Randomized Clinical Trial
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.
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:
1. 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.
2. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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