Clinical Trial: Biliary Drainage in Patients With Duodenal Metal Stent

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Tokyo University

Current Primary Outcome: Time to recurrent biliary obstruction [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Tokyo University

Dates:
Date Received: February 19, 2015
Date Started: January 2010
Date Completion: September 2017
Last Updated: February 25, 2015
Last Verified: February 2015