Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance in Patients With Malignant Extrahepatic Bile Duct Obstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- technical success
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
technical success
Time Frame: 1 minute after injection of a radiocontrast agent into the expanded metal stent
metal stent was implanted successfully bridging the tumor stenosis
Secondary Outcomes
- clinical success(7 days)
- adverse events(Up to 30 days after the intervention)
- re-interventions(6 months)
- overall survival(2 years)
Investigators
Daniel Schmitz
Principal investigator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH