CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Percutaneous transhepatic biliary drainageprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03541590
NCT03541590N/ACompleted

Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction

Theresienkrankenhaus und St. Hedwig-Klinik GmbH·observational·Posted May 30, 2018·Updated May 30, 2018

In Brief

An observational study evaluating Percutaneous transhepatic biliary drainage for Bile Duct Obstruction, Extrahepatic. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2018
Enrollment StartDec 1, 2008
Primary CompletionOct 30, 2017
Study CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 8.1 years ago

Interventions

Percutaneous transhepatic biliary drainageprocedure

When ERCPs failed or was not possible to be performed due to an altered anatomy in patients with malignant extrahepatic bile duct obstruction, PTBD was performed next in all patients. Percutaneous bile duct puncture was guided by Color Doppler ultrasound. The further procedure was guided by fluoroscopy. A self-expandable metal stent (SEMS) was inserted into the obstructed bile duct by endoscopic luminal guidance in the first session. After successful SEMS implantation, the percutaneous external catheter was removed at the end of the procedure.