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

June 21, 2011 updated by: Changhai Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

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, 200433
        • Recruiting
        • Changhai Hospital, Second Military Medical University
        • Contact:
        • Principal Investigator:
          • Zhaoshen Li, M.D.
  • Slovakia
      • Astrova, Slovakia
        • Recruiting
        • Department of Surgery and Transplant Center
        • Contact:
        • Principal Investigator:
          • Rastislav KUNDA, M.D.

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
patients receiving one stent
Procedure: ERCP plus one biliary stent
ERCP ＋ one biliary stent insertion
Other Names:
  • endoscopic retrograde cholangiopancreatography
Active Comparator: 2
patients receiving two stents
Procedure: ERCP plus two biliary stents
ERCP ＋ two biliary stents insertion
Other Names:
  • endoscopic retrograde cholangiopancreatography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early complications
Time Frame: 30 days within treatment
30 days within treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day mortality
Time Frame: 30 days within treatment
30 days within treatment
Late complications
Time Frame: 30 days after treatment
30 days after treatment
Median survival
Time Frame: From stent insertion to the death of the patient
From stent insertion to the death of the patient
Successful drainage
Time Frame: One month after stent insertion
One month after stent insertion

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

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

May 1, 2008

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai-080129

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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