Clinical trial NCT00653978: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cholangiocarcinoma
Keywords: ERCP
cholangiocarcinoma
hilar stricture
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2008-04-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Early complications
timeFrame: 30 days within treatment
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days within treatment
measure: Late complications
timeFrame: 30 days after treatment
measure: Median survival
timeFrame: From stent insertion to the death of the patient
measure: Successful drainage
timeFrame: One month after stent insertion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
city: Astrova
country: Slovakia
facility: Department of Surgery and Transplant Center
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References: