Status:
TERMINATED
Quality of Life After Biliodigestive Anastomosis (BDA) or Stents to Treat Biliary Obstruction in Pancreas Cancer
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Local Tumor Spread
Advanced Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs. endoscopical stenting for palliation of biliary obstruction due to locally unresectable or metastatic pancreat...
Detailed Description
The aim of this multi-centre, prospective-randomised study was to compare the effectiveness of palliative applications on patients suffering from a local, advanced and/or hepatic, metastasising, non-r...
Eligibility Criteria
Inclusion
- Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice.
- Performance-status of 50 or above on the Karnofsky-scale (see attachment).
- Adequate bone marrow reserves: leukocyte level \> 3.5 x 10´/l, thrombocyte level level \> 100 x 10/l; Haemoglobin\> 80g/l.
- Male or female patients, at least 18 years old.
- Women of child bearing age must be sufficient protected against pregnancy (contraception) during and for 3 months after the end of the study.
Exclusion
- Adult patients with focal, advanced adenocarcinoma of the pancreas head and no jaundice; also no jaundice in their anamnesis and with no endoscopic retrograde cholangio-pancreaticography (ERCP)-induced intervention.
- Pregnancy
- Breast feeding
- Contra-indication for gemcitabine
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01887041
Start Date
January 1 2010
End Date
December 1 2015
Last Update
July 5 2022
Active Locations (1)
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1
Universtätsklinik Hamburg-Eppendorf
Hamburg, Germany, 20246