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

NCT01025414 | Completed Phase 4

• 2 other identifiers: Fistula-1CMUJ-FIS-1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure

  30 days

Secondary Outcomes (1)

• Rates of fistula and treatment-related complications, changes in quality of life

  30 days

Interventions

enteral nutrition DRUG

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

Also known as: Peptisorb, Nutricia Ltd, Netherlands

Parenteral nutrition DRUG

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

Also known as: intravenous feeding

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Nutrimed Medical Corporation

Krakow, Malopolska, 30-798, Poland

Location

Related Publications (1)

• Klek S, Sierzega M, Turczynowski L, Szybinski P, Szczepanek K, Kulig J. Enteral and parenteral nutrition in the conservative treatment of pancreatic fistula: a randomized clinical trial. Gastroenterology. 2011 Jul;141(1):157-63, 163.e1. doi: 10.1053/j.gastro.2011.03.040. Epub 2011 Mar 24.

  PMID: 21439962 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Enteral Nutrition; Parenteral Nutrition

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Stanislaw Klek, MD PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: July 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 3, 2009

Record last verified: 2009-12

Locations

PL (1)