TerminatedPhase 4

Quality of Life After Biliodigestive Anastomosis (BDA) or Stents to Treat Biliary Obstruction in Pancreas Cancer

Stopped: Recruiting problems

Germany24 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Outcome of Quality of Life.

Timeframe: 2 1/2 years

Trial details

NCT IDNCT01887041

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

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