An interventional study of Percutaneous transhepatic implantation of self-expandable metal stent in Bile Duct Obstruction and Extrahepatic Cholestasis, sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Not applicable, Interventional, and Treatment
The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.
Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. PTBD with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (AE) than PTBD with secondary metal stent implantation. However, it is not clear whether PTBD with primary metal stent implantation shows fewer adverse events than PTBD with secondary stent implantation. The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. The focus of this single center study will be to compare the two approaches in terms of adverse events. Adverse events in PTBD might range from very mild to fatal. Therefore, the severity of the adverse events has been considered in the calculation.
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's enrollment of 40 is below the median of 55 across 135 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →Theresienkrankenhaus und St. Hedwig-Klinik GmbH is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
PTBD with primary metal stent implantation is performed in the same session as a one step-procedure
Device: Percutaneous transhepatic implantation of self-expandable metal stent
PTBD with secondary metal stent implantation is performed as a two step-procedure with metal stent implantation 3 to 7 days after previous percutaneous transhepatic biliary drainage and insertion of a plastic catheter
Device: Percutaneous transhepatic implantation of self-expandable metal stent
A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease
Adverse events
All adverse events which have been documented in the medical record were analyzed and classified as mild, moderate, severe or fatal/death according to the AE severity grading system of the American Society of Gastrointestinal Endoscopy (ASGE)
Time frame: From the intervention until 30 days after
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Theresienkrankenhaus und St. Hedwig-Klinik GmbH