NCT00653978

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	ERCP plus one biliary stent	ERCP ＋ one biliary stent insertion
PROCEDURE	ERCP plus two biliary stents	ERCP ＋ two biliary stents insertion

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2008-04-07
• Last updated: 2011-06-22

Locations

2 sites across 2 countries: China, Slovakia