Advanced Cancer Clinical Trial
— BYPAPAOfficial title:
Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice
Verified date | June 2022 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 pancreatic cancer. In the past, endoscopy seems to have been favoured based on older studies, but with new chemotherapeutic regimens available, the likelihood to experience stent complications has increased. Therefore, the issue as to which palliation should be favoured has to be reconsidered.
Status | Terminated |
Enrollment | 24 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice. 2. Performance-status of 50 or above on the Karnofsky-scale (see attachment). 3. Adequate bone marrow reserves: leukocyte level > 3.5 x 10ยด/l, thrombocyte level level > 100 x 10/l; Haemoglobin> 80g/l. 4. Male or female patients, at least 18 years old. 5. Women of child bearing age must be sufficient protected against pregnancy (contraception) during and for 3 months after the end of the study. Exclusion Criteria: 1. 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. 2. Pregnancy 3. Breast feeding 4. Contra-indication for gemcitabine |
Country | Name | City | State |
---|---|---|---|
Germany | Universtätsklinik Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Outcome of Quality of Life. | 2 1/2 years | ||
Secondary | The incidence of surgical complications and complications, with regard to the endo-scopic stent insertion, are further aspects that shall be examined in this study. | 2 1/2 years |
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