Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance

Completed

• Conditions: Bile Duct Obstruction, Extrahepatic

• Registration Number: NCT03541590
• Lead Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-12-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-12-31
• Study First Submitted: 2018-04-23
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-17
• Last Update Submitted: 2018-05-17
• Study First Posted: 2018-05-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
technical success	1 minute after injection of a radiocontrast agent into the expanded metal stent	metal stent was implanted successfully bridging the tumor stenosis

Secondary Outcome Measures

Name	Time	Method
clinical success	7 days	decrease of Serum Bilirubin level \>50%
adverse events	Up to 30 days after the intervention	the report of any adverse events after the procedure, grading of adverse events according to the ASGE lexicon's severity grading system
re-interventions	6 months	Number of re-interventions (ERCP or PTCD) that are necessary after successful PTBD (for example due to stent migration or stent occlusion)
overall survival	2 years	death in the follow up afterperformed PTBD

Trial Locations

Locations (1)

Tertiary referral hospital: Theresienkrankenhaus und St. Hedwig Hospital, Academic; 🇩🇪 Mannheim, Germany