Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional
Phase: Phase 4

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 description: 
      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.
    

Intervention name(s): enteral nutrition; Parenteral nutrition
Intervention type(s): Drug; Drug
Intervention description(s): Group A - enteral feeding was started 2 to 4 hours after catheter placement via enteral tube inserted via endoscope below the Treitz's ligament into first intestinal loop (location of the tip) (Nutricial Ltd. Flocare). The initial flow rate was 10 ml/ hour, final 125 ml/ hour. Energy requirements was calculated using following rule: 0.15-0.2 gN/ kg and 130-170 kcal/ gN. Diet: Peptisorb (Nutricia Ltd.) - oligopeptide diet well tolerated by intestines; Parenteral nutrition was started 2 to 4 hours after venous catheter placement (standard Arrow type, the tip located 5 cm over right vestibule, the location confirmed on chest X-ray) and continued until oral diet covering at least 60% of daily caloric and protein demand. The energy requirements were calculated using following rule: 0.15-0.2 gN/ kg and 130-170 kcal/ gN. Parenteral diets: Aminoplasmal 10%, Lipofundin LCT/MCT 10 and 20%, 40% Glucose, Tracutil (microelements and trace elements), Cernevit (vitamins), electrolytes
Other intervention name(s): Peptisorb, Nutricia Ltd, Netherlands; intravenous feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic fistula