Biliary Drainage in Patients With Duodenal Metal Stent

February 25, 2015 updated by: Hiroyuki Isayama, MD, PhD, Tokyo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200438
        • Eastern Hepatobiliary Hospital, Second Military Medical University
  • Hong Kong
      • Shatin, Hong Kong
        • The Prince of Wales Hospital
  • India
      • Hyderabad, India, 500082
        • Asian institute of Gastroenterology
  • Japan
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University
      • Gifu, Japan, 501-1194
        • Gifu University
      • Hiroshima, Japan, 722-8508
        • Onomichi General Hospital
      • Hokkaido, Japan, 006-8555
        • Teine-Keijinkai Hospital
      • Hokkaido, Japan, 060-8543
        • Sapporo Medical University
      • Hokkaido, Japan, 060-8648
        • Hokkaido University School of Medicine
      • Osaka, Japan, 589-8511
        • Kinki University
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University
      • Tokyo, Japan, 153-8515
        • Toho University Ohashi Medical Center
      • Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center
      • Tokyo, Japan, 113-8655
        • Graduate School of Medicine, The University of Tokyo
      • Tokyo, Japan, 158-0098
        • Kanto Central Hospital
      • Tokyo, Japan, 164-8541
        • Tokyo Metropolitan Police Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 140-887
        • Soon Chun Hyang University School of Medicine
  • Malaysia
      • Kuala Lumpur, Malaysia, 50450
        • Prince Court Medical Center
  • Singapore
      • Outram Road, Singapore, 169608
        • Singapore General Hospital
      • Simei, Singapore, 529889
        • Changi General Hospital
  • Taiwan
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent the initial duodenal SEMS between Jan/1/2010 and Jun/30/2014 are included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUS-BD or ERCP with duodenal SEMS
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
EUS-BD or ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year
Functional success rate of biliary drainage
Time Frame: 2 weeks
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)
Time Frame: 30 days
Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines.
30 days
Survival time
Time Frame: Up to 2 year
Survival time is defined as the period between biliary stent placement and death.
Up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo University

Investigators

  • Principal Investigator: Hiroyuki Isayama, MD, PhD, Graduate School of Medicine, The University of Tokyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (ESTIMATE)

March 3, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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