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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Changhai Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00653978
First received: April 2, 2008
Last updated: June 21, 2011
Last verified: July 2009

April 2, 2008
June 21, 2011
May 2008
October 2011   (final data collection date for primary outcome measure)
Early complications [ Time Frame: 30 days within treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653978 on ClinicalTrials.gov Archive Site
  • 30-day mortality [ Time Frame: 30 days within treatment ] [ Designated as safety issue: No ]
  • Late complications [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: From stent insertion to the death of the patient ] [ Designated as safety issue: No ]
  • Successful drainage [ Time Frame: One month after stent insertion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cholangiocarcinoma
  • Procedure: ERCP plus one biliary stent
    ERCP + one biliary stent insertion
    Other Name: endoscopic retrograde cholangiopancreatography
  • Procedure: ERCP plus two biliary stents
    ERCP + two biliary stents insertion
    Other Name: endoscopic retrograde cholangiopancreatography
  • Experimental: 1
    patients receiving one stent
    Intervention: Procedure: ERCP plus one biliary stent
  • Active Comparator: 2
    patients receiving two stents
    Intervention: Procedure: ERCP plus two biliary stents
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Zhaoshen Li, MD 86-21-25070552 li.zhaoshen@hotmail.com
Contact: Yu Bai, MD 86-21-25074725 baiyu1998@hotmail.com
China,   Slovakia
 
NCT00653978
Changhai-080129
Yes
Zhaoshen Li, Changhai Hospital, Second Military Medical University
Changhai Hospital
Not Provided
Principal Investigator: Zhaoshen Li, MD Changhai Hospital, Second Military Medical University
Changhai Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP