|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01025414 |
|
Date of registration:
|
02/12/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective Study
FIS-1 |
|
Scientific title:
|
The Use of Enteral Nutrition in the Treatment of Pancreatic Fistulas - A Prospective, Randomized Clinical Trial |
|
Date of first enrolment:
|
July 2006 |
|
Target sample size:
|
78 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01025414 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Poland
| | | | | | | |
|
Contacts
|
|
Name:
|
Stanislaw Klek, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Jagiellonian University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Pancreatic Fistula
|
|
Intervention(s)
|
|
Drug: enteral nutrition
|
|
Drug: Parenteral nutrition
|
|
Primary Outcome(s)
|
|
The ratio of pancreatic fistula closure after 30 days is selected as the primary outcome measure
[Time Frame: 30 days]
|
|
Secondary Outcome(s)
|
|
Rates of fistula and treatment-related complications, changes in quality of life
[Time Frame: 30 days]
|
|
Secondary ID(s)
|
|
CMUJ-FIS-1
|
|
Fistula-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|