Biliary Drainage in Patients With Duodenal Metal Stent

Sponsor

Tokyo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02376907

Collaborator

(none)

200

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Jaundice	Procedure: Biliary drainage

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Causes of recurrent biliary obstruction [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 [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) [30 days]
Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines.
Survival time [Up to 2 year]
Survival time is defined as the period between biliary stent placement and death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Eastern Hepatobiliary Hospital, Second Military Medical University	Shanghai	China	200438
2	The Prince of Wales Hospital	Shatin	Hong Kong
3	Asian Institute of Gastroenterology	Hyderabad	India	500082
4	Fukushima Medical University	Fukushima	Japan	960-1295
5	Gifu University	Gifu	Japan	501-1194
6	Onomichi General Hospital	Hiroshima	Japan	722-8508
7	Teine-Keijinkai Hospital	Hokkaido	Japan	006-8555
8	Sapporo Medical University	Hokkaido	Japan	060-8543
9	Hokkaido University School of Medicine	Hokkaido	Japan	060-8648
10	Kinki University	Osaka	Japan	589-8511
11	Saitama Medical University International Medical Center	Saitama	Japan	350-1298
12	Graduate School of Medicine, The University of Tokyo	Tokyo	Japan	113-8655
13	Japanese Red Cross Medical Center	Tokyo	Japan	150-8935
14	Toho University Ohashi Medical Center	Tokyo	Japan	153-8515
15	Kanto Central Hospital	Tokyo	Japan	158-0098
16	Tokyo Medical University	Tokyo	Japan	160-0023
17	Tokyo Metropolitan Police Hospital	Tokyo	Japan	164-8541
18	Asan Medical Center	Seoul	Korea, Republic of	138-736
19	Soon Chun Hyang University School of Medicine	Seoul	Korea, Republic of	140-887
20	Prince Court Medical Center	Kuala Lumpur	Malaysia	50450
21	Singapore General Hospital	Outram Road	Singapore	169608
22	Changi General Hospital	Simei	Singapore	529889
23	National Taiwan University Hospital	Taipei	Taiwan	10048
24	Chulalongkorn University	Bangkok	Thailand	10330
25	Rajavithi Hospital	Bangkok	Thailand	10400