Biliary Drainage in Patients With Duodenal Metal Stent

• Conditions: Jaundice

• Registration Number: NCT02376907
• Lead Sponsor: Tokyo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrent biliary obstruction	Up to 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (25)

Eastern Hepatobiliary Hospital, Second Military Medical University; 🇨🇳 Shanghai, China

The Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India

Fukushima Medical University; 🇯🇵 Fukushima, Japan

Gifu University; 🇯🇵 Gifu, Japan

Onomichi General Hospital; 🇯🇵 Hiroshima, Japan

Teine-Keijinkai Hospital; 🇯🇵 Hokkaido, Japan

Sapporo Medical University; 🇯🇵 Hokkaido, Japan

Hokkaido University School of Medicine; 🇯🇵 Hokkaido, Japan

Kinki University; 🇯🇵 Osaka, Japan

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