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Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

Primary Purpose

Cholangiocarcinoma

Status

Unknown status

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ERCP plus one biliary stent

ERCP plus two biliary stents

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring ERCP, cholangiocarcinoma, hilar stricture

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP.
Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up.
All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent.
Full and informed consent is obtained.

Exclusion Criteria:

Refuse to participate in this study.
Refuse to provide informed consent.
Refuse to be placed with plastic stents.
Physically unfit for endoscopic treatment.

Sites / Locations

Changhai Hospital, Second Military Medical UniversityRecruiting
Department of Surgery and Transplant CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patients receiving one stent

patients receiving two stents

Outcomes

Primary Outcome Measures

Early complications

Secondary Outcome Measures

30-day mortality

Late complications

Median survival

Successful drainage

Full Information

NCT ID

NCT00653978

First Posted

April 2, 2008

Last Updated

June 21, 2011

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00653978

Brief Title

Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

Official Title

Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Changhai Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.

Detailed Description

Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma

Keywords

ERCP, cholangiocarcinoma, hilar stricture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients receiving one stent

Arm Title

Arm Type

Active Comparator

Arm Description

patients receiving two stents

Intervention Type

Procedure

Intervention Name(s)

ERCP plus one biliary stent

Other Intervention Name(s)

endoscopic retrograde cholangiopancreatography

Intervention Description

ERCP ＋ one biliary stent insertion

Intervention Type

Procedure

Intervention Name(s)

ERCP plus two biliary stents

Other Intervention Name(s)

endoscopic retrograde cholangiopancreatography

Intervention Description

ERCP ＋ two biliary stents insertion

Primary Outcome Measure Information:

Title

Early complications

Time Frame

30 days within treatment

Secondary Outcome Measure Information:

Title

30-day mortality

Time Frame

30 days within treatment

Title

Late complications

Time Frame

30 days after treatment

Title

Median survival

Time Frame

From stent insertion to the death of the patient

Title

Successful drainage

Time Frame

One month after stent insertion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP. Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up. All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent. Full and informed consent is obtained. Exclusion Criteria: Refuse to participate in this study. Refuse to provide informed consent. Refuse to be placed with plastic stents. Physically unfit for endoscopic treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaoshen Li, MD

Phone

86-21-25070552

li.zhaoshen@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Bai, MD

Phone

86-21-25074725

baiyu1998@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoshen Li, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital, Second Military Medical University

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaoshen Li, M.D.

Phone

86-21-25070552

li.zhaoshen@hotmail.com

First Name & Middle Initial & Last Name & Degree

Zhaoshen Li, M.D.

Facility Name

Department of Surgery and Transplant Center

City

Astrova

Country

Slovakia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rastislav KUNDA, M.D.

Phone

+421-48-4413000, 4412988

rkunda@hotmail.com

First Name & Middle Initial & Last Name & Degree

Rastislav KUNDA, M.D.

12. IPD Sharing Statement

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Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

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