Ultrasound-guided Percutaneous Biliary Drainage Versus Endoscopic Ultrasound-guided Biliary Drainage
Germany216 participantsStarted 2018-12-01
Plain-language summary
Prospective multi-site study of ultrasound-guided percutaneous biliary drainage and endoscopic ultrasound-guided biliary drainage with implantation of a self-expanding metal stent in patients with malignant, distal bile duct obstruction (PUMa-study)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inoperable, malignant disease with extrahepatic bile duct obstruction (infra- hilar)
* ERCP was not successful or wasn´t possible due to anatomical reasons (for example status post-gastrectomy)
* At least twofold elevated bilirubin level (\> 2mg/dl)
* Histologically verified malignant disease
* Abdominal ultrasound was performed
* Computed tomography or magnetic resonance imaging of the abdomen was performed
* A written consent was given
Exclusion Criteria:
* Relevant blood coagulation disorder (Quick \< 50%, Partial thromboplastin time \> 50 sec., thrombocytes \< 50/nl)
* Extrahepatic cholangiocellular carcinoma (Klatskin tumor) Bismuth II-IV or intrahepatic cholangiocellular carcinoma
* Operable, malignant disease or disease which can be cured by chemotherapy (for example aggressive Non Hodgkin-lymphoma)
* Pregnancy or breastfeeding
* Participation in another trial concerning PTBD or EUBD
What they're measuring
1
Technical success
Timeframe: 1 minute after injection of a radiocontrast agent into the expanded metal stent
Trial details
NCT IDNCT03546049
SponsorTheresienkrankenhaus und St. Hedwig-Klinik GmbH