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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00653978
• Other study ID #: Changhai-080129
• Status: Recruiting
• Phase: Phase 3
• First received: April 2, 2008
• Last updated: June 21, 2011
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2009
• Source: Changhai Hospital
• Contact: Zhaoshen Li, MD
• Phone: 86-21-25070552
• Email: li.zhaoshen[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Procedure:
• ERCP plus one biliary stent
ERCP + one biliary stent insertion
• ERCP plus two biliary stents
ERCP + two biliary stents insertion

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai
Slovakia	Department of Surgery and Transplant Center	Astrova

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Countries where clinical trial is conducted

China,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early complications		30 days within treatment	No
Secondary	30-day mortality		30 days within treatment	No
Secondary	Late complications		30 days after treatment	No
Secondary	Median survival		From stent insertion to the death of the patient	No
Secondary	Successful drainage		One month after stent insertion	No