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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bile Duct Obstruction, Extrahepatic

Intervention / Treatment
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* Procedure: Percutaneous transhepatic biliary drainage


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous transhepatic biliary drainage|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success | metal stent was implanted successfully bridging the tumor stenosis | 1 minute after injection of a radiocontrast agent into the expanded metal stent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success | decrease of Serum Bilirubin level >50% | 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 | 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) | 6 months | 
| overall survival | death in the follow up afterperformed PTBD | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous biliary drainage