Clinical Trial: Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective, Randomized Clinical Trial

Brief Summary: 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.

Detailed Summary:

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.

B
Sponsor: Jagiellonian University

Current Primary Outcome: The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure [ Time Frame: 30 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Rates of fistula and treatment-related complications, changes in quality of life [ Time Frame: 30 days ]

Original Secondary Outcome: Same as current

Information By: Jagiellonian University

Dates:
Date Received: December 2, 2009
Date Started: July 2006
Date Completion:
Last Updated: December 2, 2009
Last Verified: December 2009