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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

patients receiving one stent

Group Type EXPERIMENTAL

ERCP plus one biliary stent

Intervention Type PROCEDURE

ERCP ＋ one biliary stent insertion

2

patients receiving two stents

Group Type ACTIVE_COMPARATOR

ERCP plus two biliary stents

Intervention Type PROCEDURE

ERCP ＋ two biliary stents insertion

Interventions

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ERCP plus one biliary stent

ERCP ＋ one biliary stent insertion

Intervention Type PROCEDURE

ERCP plus two biliary stents

ERCP ＋ two biliary stents insertion

Intervention Type PROCEDURE

Other Intervention Names

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endoscopic retrograde cholangiopancreatography endoscopic retrograde cholangiopancreatography

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No