Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study (FIS-1)

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01025414
First received: December 2, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pancreatic Fistula
Drug: enteral nutrition
Drug: Parenteral nutrition
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Rates of fistula and treatment-related complications, changes in quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: July 2006
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: enteral nutrition
    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
    Other Name: Peptisorb, Nutricia Ltd, Netherlands
    Drug: Parenteral nutrition
    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 Name: intravenous feeding
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the presence of pancreatic fistula (PF) (verification of serum lipase concentration in drained fluid, findings on imaging modalities: endoscopic retrograde cholangiopancreatography (ERCP), helical computed tomography(hCT), magnetic reissonance imaging (MRI), ultrasonography (USG) or intraoperative surgeon's verification - any or some or all of them)
  • good general status (Karnoffsky > 80, Eastern Cooperative Oncology Group (ECOG) scale 0 or 1; see Appendix 2);
  • NRS and MUST evaluation - low/ medium risk patients not requiring parenteral nutrition as the essence treatment option,
  • no PF's complication requiring special treatment present, such as intraabdominal abscess formation, pleuropneumonia, bleeding, paralytic ileus, etc. Complications will be diagnosed and treated according to generally accepted medical knowledge, standards and procedures.
  • age below 80 and over 18;
  • in case of neoplastic patients: no confirmed neoplastic dissemination nor distant metastases;
  • no severe concomitant disease (heart failure, COPD, CABG, etc.);
  • no history of known allergies or drug intolerance;
  • informed consent

Exclusion Criteria:

  • PF diagnosis uncertain;
  • poor general status (Karnoffsky <80, ECOG > 1);
  • the presence of serious complications; see above
  • recent history of severe heart, lung, kidney or liver failure;
  • the history of allergies or drug intolerance;
  • confirmed neoplastic spread;
  • severe malnutrition requiring combined treatment (PN+EN)
  • withdrawal of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025414

Locations
Poland
Nutrimed Medical Corporation
Krakow, Malopolska, Poland, 30-798
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Stanislaw Klek, MD PhD Jagiellonian University
  More Information

No publications provided by Jagiellonian University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanislaw Klek MD PhD, Jagiellonian University
ClinicalTrials.gov Identifier: NCT01025414     History of Changes
Other Study ID Numbers: Fistula-1, CMUJ-FIS-1
Study First Received: December 2, 2009
Last Updated: December 2, 2009
Health Authority: Poland: Ethics Committee

Keywords provided by Jagiellonian University:
pancreatic fistula

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014