Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures - Full Text View

Sponsored by:	Changhai Hospital
Information provided by:	Changhai Hospital
ClinicalTrials.gov Identifier:	NCT00653978

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 III

MedlinePlus related topics: Endoscopy

Drug Information available for: Bismuth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures: A Prospective, Multi-Center Randomized Controlled Trial

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 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients receiving one stent	Procedure: ERCP plus one biliary stent ERCP ＋ one biliary stent insertion
2: Active Comparator patients receiving two stents	Procedure: ERCP plus two biliary stents ERCP ＋ two biliary stents insertion

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

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

Responsible Party:	Changhai Hospital, Second Military Medical University ( Zhaoshen Li )
Study ID Numbers:	Changhai-080129
Study First Received:	April 2, 2008
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00653978
Health Authority:	China: State Food and Drug Administration

Keywords provided by Changhai Hospital:

ERCP
cholangiocarcinoma
hilar stricture

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Cholangiocarcinoma
Constriction, Pathologic
Adenocarcinoma

Bismuth
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009