Primary Versus Secondary Metal Stent Implantation in PTBD

Study Overview
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Brief Summary
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The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.

Detailed Description
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Percutaneous transhepatic biliary interventions (PBI) are used in biliary tract diseases when endoscopic access was not successful or not possible due to anatomical changes after abdominal surgery. Self-expandible metal stents (SEMS) can be applied percutaneously in patients with malignant extrahepatic bile duct obstruction. In this setting, PTBD is usually performed as a two step-procedure with primary drainage of the accumulated bile fluid by an external or an external/internal plastic stent and a secondary metal stent implantation at an interval of a few days. PTBD with primary metal stent implantation might shorten the hospital stay and is therefore equal to the increasingly used method of endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD offers a one step-procedure with primary metal stent implantation which is probably associated with lesser adverse events (AE) than PTBD with secondary metal stent implantation. However, it is not clear whether PTBD with primary metal stent implantation shows fewer adverse events than PTBD with secondary stent implantation. The aim of this study is to retrospectively analyze the prospectively collected data of PTBDs with primary or secondary metal stent implantation in patients with proximal and distal malignant bile duct obstruction. The focus of this single center study will be to compare the two approaches in terms of adverse events. Adverse events in PTBD might range from very mild to fatal. Therefore, the severity of the adverse events has been considered in the calculation.

Official Title
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Primary Versus Secondary Metal Stent Implantation in PTBD in Patients With Extrahepatic Malignant Bile Duct Obstruction

Conditions
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Bile Duct Obstruction, Extrahepatic Cholestasis

Intervention / Treatment
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* Device: Percutaneous transhepatic implantation of self-expandable metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PTBD with metal stent implantation into the extrahepatic bile duct malignant and non-resectable extrahepatic bile duct obstruction Exclusion Criteria: benign extrahepatic bile duct obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospective comparison of two similar interventions with small modification
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTBD with primary metal stent implantation<br>PTBD with primary metal stent implantation is performed in the same session as a one step-procedure | Device: Percutaneous transhepatic implantation of self-expandable metal stent<br>* A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease<br>|
| Active Comparator: PTBD with secondary metal stent implantation<br>PTBD with secondary metal stent implantation is performed as a two step-procedure with metal stent implantation 3 to 7 days after previous percutaneous transhepatic biliary drainage and insertion of a plastic catheter | Device: Percutaneous transhepatic implantation of self-expandable metal stent<br>* A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All adverse events which have been documented in the medical record were analyzed and classified as mild, moderate, severe or fatal/death according to the AE severity grading system of the American Society of Gastrointestinal Endoscopy (ASGE) | From the intervention until 30 days after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile Duct Obstruction, Self Expandable Metallic Stents