An observational study in Bile Duct Obstruction, Extrahepatic, sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Observational
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.
When Endoscopic Retrograde Cholangiopancreaticography (ERCP) is not successful or is not possible to be performed due to anatomical reasons (altered anatomy after abdominal surgery) in patients with malignant extrahepatic bile duct obstruction, an alternative method is necessary for biliary drainage. 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 considering technical and clinical success, access route, procedure time, fluoroscopic time, radiation exposure, adverse events and survival probability in an observation time of six months.
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's enrollment of 66 is below the median of 100 across 65 observational 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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All patients which met the mentioned inclusion and exclusion criteria were enrolled in the study consecutively
Exclusion Criteria:
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.
technical success
metal stent was implanted successfully bridging the tumor stenosis
Time frame: 1 minute after injection of a radiocontrast agent into the expanded metal stent
clinical success
decrease of Serum Bilirubin level \>50%
Time frame: 7 days
adverse events
the report of any adverse events after the procedure, grading of adverse events according to the ASGE lexicon's severity grading system
Time frame: Up to 30 days after the intervention
re-interventions
Number of re-interventions (ERCP or PTCD) that are necessary after successful PTBD (for example due to stent migration or stent occlusion)
Time frame: 6 months
overall survival
death in the follow up afterperformed PTBD
Time frame: 2 years
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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