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
  Purpose

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


Condition Intervention Phase
Cholangiocarcinoma
Procedure: ERCP plus one biliary stent
Procedure: ERCP plus two biliary stents
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-center Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Early complications [ Time Frame: 30 days within treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: May 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients receiving one stent
Procedure: ERCP plus one biliary stent
ERCP + one biliary stent insertion
Other Name: endoscopic retrograde cholangiopancreatography
Active Comparator: 2
patients receiving two stents
Procedure: ERCP plus two biliary stents
ERCP + two biliary stents insertion
Other Name: endoscopic retrograde cholangiopancreatography

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653978

Contacts
Contact: Zhaoshen Li, MD 86-21-25070552 li.zhaoshen@hotmail.com
Contact: Yu Bai, MD 86-21-25074725 baiyu1998@hotmail.com

Locations
China
Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: Zhaoshen Li, M.D.    86-21-25070552    li.zhaoshen@hotmail.com   
Principal Investigator: Zhaoshen Li, M.D.         
Slovakia
Department of Surgery and Transplant Center Recruiting
Astrova, Slovakia
Contact: Rastislav KUNDA, M.D.    +421-48-4413000, 4412988    rkunda@hotmail.com   
Principal Investigator: Rastislav KUNDA, M.D.         
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: Zhaoshen Li, MD Changhai Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00653978     History of Changes
Other Study ID Numbers: Changhai-080129
Study First Received: April 2, 2008
Last Updated: June 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
ERCP
cholangiocarcinoma
hilar stricture

Additional relevant MeSH terms:
Cholangiocarcinoma
Constriction, Pathologic
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014