Overview

This trial is active, not recruiting.

Condition jaundice
Treatment biliary drainage
Sponsor Tokyo University
Start date January 2010
End date June 2014
Trial size 200 participants
Trial identifier NCT02376907, 10639

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
biliary drainage
EUS-BD or ERCP

Primary Outcomes

Measure
Time to recurrent biliary obstruction
time frame: Up to 1 year

Secondary Outcomes

Measure
Causes of recurrent biliary obstruction
time frame: Up to 1 year
Functional success rate of biliary drainage
time frame: 2 weeks
Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)
time frame: 30 days
Survival time
time frame: Up to 2 year

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction
Principal investigator Hiroyuki Isayama, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Tokyo University.