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

NCT00653978 | Unknown Phase 3 DMC

• 1 other identifier: Changhai-080129
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Cholangiocarcinoma

Keywords

ERCP; cholangiocarcinoma; hilar stricture

Outcome Measures

Primary Outcomes (1)

• Early complications

  30 days within treatment

Secondary Outcomes (4)

• 30-day mortality

  30 days within treatment

• Late complications

  30 days after treatment

• Median survival

  From stent insertion to the death of the patient

• Successful drainage

  One month after stent insertion

Study Arms (2)

1

EXPERIMENTAL

patients receiving one stent

Procedure: ERCP plus one biliary stent

2

ACTIVE COMPARATOR

patients receiving two stents

Procedure: ERCP plus two biliary stents

Interventions

ERCP plus one biliary stent PROCEDURE

ERCP ＋ one biliary stent insertion

Also known as: endoscopic retrograde cholangiopancreatography

1

ERCP plus two biliary stents PROCEDURE

ERCP ＋ two biliary stents insertion

Also known as: endoscopic retrograde cholangiopancreatography

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Refuse to participate in this study.
• Refuse to provide informed consent.
• Refuse to be placed with plastic stents.
• Physically unfit for endoscopic treatment.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (2)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

Department of Surgery and Transplant Center

Astrova, Slovakia

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Zhaoshen Li, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

86-21-25070552; li.zhaoshen@hotmail.com

Yu Bai, MD

CONTACT

86-21-25074725; baiyu1998@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2009-07

Locations

CN (1); SL (1)