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

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

Detailed Description
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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.

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

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Procedure: ERCP plus one biliary stent
* Procedure: ERCP plus two biliary stents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients receiving one stent | Procedure: ERCP plus one biliary stent<br>* ERCP ＋ one biliary stent insertion<br>* Other names: endoscopic retrograde cholangiopancreatography;|
| Active Comparator: 2<br>patients receiving two stents | Procedure: ERCP plus two biliary stents<br>* ERCP ＋ two biliary stents insertion<br>* Other names: endoscopic retrograde cholangiopancreatography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early complications |  | 30 days within treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, cholangiocarcinoma, hilar stricture