Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jagiellonian University
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