Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome of Quality of Life.
2 1/2 years
Jacob R Izbicki, MD
Germany: Ethics Commission
1 - mtachezy