Quality of Life After BDA or Stents to Treat Biliary Obstruction in Pancreas Cancer (BYPAPA)
|Local Tumor Spread Advanced Cancer Metastasized Pancreatic Cancer Non-resectable Jaundice||Procedure: Stent Procedure: Biliodigestive anastomosis||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice|
- Outcome of Quality of Life. [ Time Frame: 2 1/2 years ]
- 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. [ Time Frame: 2 1/2 years ]
|Study Start Date:||January 2010|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Stent
Arm B, after randomisation the biliary tract stents shall remain. The patients in study arm B will also receive chemotherapy and gemcitabine, according to the recommended palliative therapy for a pancreas carcinoma.
Endoscopically inserted biliary tract drainage
Active Comparator: Biliodigestive anastomosis
Study arm A will, after randomisation, have a biliodigestive anastomosis inserted. After the healing of the wound (al least 14 days postoperative) the treatment using gemcitabine, according to the plan mentioned below.
Gemcitabine shall be administered on days 1, 8 and 15 of each 4 week cycle. The cycle is defined as a weekly, over a period of 3 consecutive weeks, applied infusions, followed by 1 week pause. On the day of therapy a dosage of 1000 mg/ml body surface shall be administered, intravenous, over a period of 30 minutes.
Procedure: Biliodigestive anastomosis
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-resectable pancreas head carcinoma and jaundice.
Before randomisation, all patients are fitted with an endoscopically inserted biliary tract drainage endoscopically inserted. When postoperatively ascertained that the pancreas head carcinoma is non-resectable, the patient shall be electronically registered and randomly assigned to one of the palliative strategies. Group 1 will be fitted with a biliodigestive anastomosis. Group 2 will continue with the endoscopically inserted drainage. Regardless of which group they belong to, all patients will receive a palliative chemotherapy.
The primary parameter is the average quality of life over a period of 6 months post-OP, to be analysed monthly using identical questionnaires. The comparison of the randomisation groups will be carried out using a co-variance analysis (ANCOVA) with the initial value, taken directly before the OP, to be used as co-variant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887041
|Hamburg, Germany, 20246|
|Principal Investigator:||Jacob R Izbicki, MD||Universitätsklinik Hamburg|