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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Early complications
Secondary Outcome
30-day mortality
Condition
Cholangiocarcinoma
Intervention
ERCP plus one biliary stent
Study Arms / Comparison Groups
1
Description: patients receiving one stent
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
150
Start Date
May 2008
Completion Date
December 2011
Primary Completion Date
October 2011
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.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Zhaoshen Li, MD, 86-21-25070552, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00653978
Organization ID
Changhai-080129
Study Sponsor
Changhai Hospital
Study Sponsor
Zhaoshen Li, MD, Principal Investigator, Changhai Hospital
Verification Date
July 2009