Biliary Drainage in Patients With Duodenal Metal Stent

Study Overview
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Brief Summary
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This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

Detailed Description
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This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.

Official Title
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Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction

Conditions
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Jaundice

Intervention / Treatment
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* Procedure: Biliary drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO. Patients who underwent endoscopic biliary drainage for nonresectable MBO. MBO was located ≥ 2 cm from the bifurcation. Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement. Age ≥20 years. Irrespective of sex and a primary disease. Exclusion Criteria: Patients who underwent surgical bypass for GOO. Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS. Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.). Patients who would not give a consent to the report of their own data. Patients considered ineligible for inclusion in the study by an investigator for other reasons.

Ages Eligible for Study
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Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUS-BD or ERCP with duodenal SEMS<br>Patients who underwent endoscopic placement of a duodenal self-expandable metal stent (SEMS) for nonresectable malignant GOO and endoscopic biliary drainage for nonresectable distal MBO. | Procedure: Biliary drainage<br>* EUS-BD or ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrent biliary obstruction | Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of recurrent biliary obstruction | Causes of recurrent biliary obstruction include sludge, food impaction, ingrowth, tumor overgrowth, hemobilia and others. | Up to 1 year | 
| Functional success rate of biliary drainage | Functional success is defined when bilirubin decreases < 50% or is normalized within 2 weeks. | 2 weeks | 
| Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity) | Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines. | 30 days | 
| Survival time | Survival time is defined as the period between biliary stent placement and death. | Up to 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, distal malignant biliary obstruction, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, gastric outlet obstruction