Clinical trial NCT01887041: Quality of Life After Biliodigestive Anastomosis (BDA) or Stents to Treat Biliary Obstruction in Pancreas Cancer
Official title: Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Local Tumor Spread
Advanced Cancer
Metastasized
Pancreatic Cancer Non-resectable
Jaundice
Keywords: Advanced, metastasising pancreatic head carcinoma
Jaundice
Biliodigestive anastomosis
Endoscopically inserted biliary tract drainage
Quality of Life
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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-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-operatively, 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 operation, to be used as co-variant.

Eligibility criteria: 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 10´/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

Primary outcomes:
measure: Outcome of Quality of Life.
timeFrame: 2 1/2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 1/2 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universtätsklinik Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinik Hamburg
name: Jacob R Izbicki, MD
role: PRINCIPAL_INVESTIGATOR
References: