UnknownNot Applicable

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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

Contact for this trial

Daniel Schmitz, Dr.med.

00496214245575 d.schmitz@theresienkrankenhaus.de

View on ClinicalTrials.gov More Bile Duct Obstruction, Extrahepatic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.