Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Lum… (NCT03541590) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance
Germany66 participantsStarted 2008-12-01
Plain-language summary
In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more re-interventions than endoscopic ultrasound guided biliary drainage (EUBD) in patients with malignant, extrahepatic bile duct obstruction. The conclusion was, that EUBD should be prefered in this clinical setting in future.
An improved technique of PTBD may provide better results for coming comparative studies.
The investigators of this retrospective study therefore analyzed all PTBDs that were performed in a period of nine years in a tertiary referral hospital. In this cohort, the analysis focused on PTBDs with primary metal stent implantation by endoscopic luminal guidance.
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:
* age ≥ 18 years
* not curatively operable, malignant disease with proximal or distal bile duct obstruction
* elevated serum bilirubin level and/or elevated alkaline phosphatase to at least a twofold degree
* histologically verified diagnosis
* at least one cross-sectional imaging method like computed tomography or magnetic resonance imaging of the abdomen has to be performed
Exclusion Criteria:
* uncorrectable coagulopathy (prothrombin time \< 50%, platelet count \< 50.000/nl, partial thromboplastin time (PTT) \> 50 sec.
* advanced tumor disease with limited life expectancy (\< 1 month)
* diffuse liver metastasis
* pregnant or breast feeding women
* potentially curatively, operable, malignant bile duct obstruction
* diseases which can be cured by chemotherapy (for example aggressive non Hodgkin-lymphoma).
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
1
technical success
Timeframe: 1 minute after injection of a radiocontrast agent into the expanded metal stent
Trial details
NCT IDNCT03541590
SponsorTheresienkrankenhaus und St. Hedwig-Klinik GmbH