Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
18 Years
90 Years
Both
Cholangiocarcinoma
Trial Information
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Early complications
Outcome Time Frame:
30 days within treatment
Safety Issue:
No
Principal Investigator
Zhaoshen Li, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Changhai Hospital, Second Military Medical University
Authority:
China: Food and Drug Administration
Study ID:
Changhai-080129
NCT ID:
NCT00653978
Start Date:
May 2008
Completion Date:
December 2011
Related Keywords:
- Cholangiocarcinoma
- ERCP
- cholangiocarcinoma
- hilar stricture
- Cholangiocarcinoma
- Constriction, Pathologic
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