Status:
UNKNOWN
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures
Lead Sponsor:
Changhai Hospital
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 endos...
Eligibility Criteria
Inclusion
- 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
- Refuse to participate in this study.
- Refuse to provide informed consent.
- Refuse to be placed with plastic stents.
- Physically unfit for endoscopic treatment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00653978
Start Date
May 1 2008
End Date
December 1 2011
Last Update
June 22 2011
Active Locations (2)
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1
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
2
Department of Surgery and Transplant Center
Astrova, Slovakia