Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction

NCT00453076 | Completed Phase 3 DMC

• 1 other identifier: 2007-11
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct stricture. The secondary goals are to assess reinterventions, complications, technical difficulties, and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metallic stent.

Conditions

Bile Duct Obstruction

Keywords

Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct stricture.

  Two year

Secondary Outcomes (1)

• The secondary goals are to assess reinterventions, complications, technical difficulties, and physician graded ease of placement and to assess toxicity of paclitaxel eluting covered self expandable metalic stent.

  Two year

Study Arms (2)

Paclitaxel eluting covered metal stent

EXPERIMENTAL

Paclitaxel eluting covered metal stent group

Device: Paclitaxel eluting covered metal stent and control covered metal stent

Control covered metal stent

ACTIVE COMPARATOR

Control covered metal stent group

Device: Paclitaxel eluting covered metal stent and control covered metal stent

Interventions

Paclitaxel eluting covered metal stent and control covered metal stent DEVICE

Paclitaxel eluting covered metal stent and control covered metal stent are inserted with standard ERCP technique

Control covered metal stent; Paclitaxel eluting covered metal stent

Eligibility Criteria

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

You may qualify if:

• Unresectable malignancy of the extrahepatic bile duct
• Age \>= 18 years and above
• Estimated life expectancy of more than 3 months
• ECOG performance status of 2 or lower
• Adequate bone marrow function
• WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL
• Hemoglobin \>9.0 g/dL
• Platelets \> 100,000/µL
• Adequate kidney function (creatinine\<1.5 mg/dL)
• No serious medical or psychological condition that would preclude study treatment
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

• Age below 18 years
• Pregnancy
• Active alcohol or drug abuse
• Simultaneously participating in another investigational drug or device study
• Allergy to stainless steel or nitinol
• Allergy to paclitaxel

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Cholestasis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Myung-Hwan Kim, MD,PhD

  Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2009
• Last Updated: June 11, 2010

Record last verified: 2006-11

Locations

KR (1)