Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

NCT00721175 | Completed Phase 4 Results

• 1 other identifier: HE500636
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Conditions

Hilar Cholangiocarcinoma

Keywords

biliary stent; plastic stent; metallic stent; Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)

  Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.

  at 2 weeks and 4 weeks after stent insertion

• Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)

  Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.

  at 2 weeks and 4 weeks after stent insertion

Secondary Outcomes (2)

• Patients Survival Times

  until patient died or 6 months after the last patient was enrolled

• Cost Effective Ratio of Metallic and Plastic Stent

  until the patients expire (Markov model)

Study Arms (2)

SEMS

EXPERIMENTAL

self-expandable metal stent group

Device: biliary stent (self expandable metallic stent)

PS

ACTIVE COMPARATOR

plastic stent group

Device: PS

Interventions

biliary stent (self expandable metallic stent) DEVICE

metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Also known as: self expandable metallic stent

SEMS

PS DEVICE

plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Also known as: Amsterdam type plastic stent

PS

Eligibility Criteria

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

You may qualify if:

• Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

You may not qualify if:

• Patients with ASA 4 or 5
• Patients with liver failure.
• Patients unable to comply with follow-up

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind Hospital. KhonKaen University.

Muang, KhonKaen, 40002, Thailand

Location

Related Publications (4)

• De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310.

  PMID: 12838220 BACKGROUND

• Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8. doi: 10.1055/s-2007-1010295.

  PMID: 7686100 BACKGROUND

• Freeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest Endosc. 2003 Jul;58(1):41-9. doi: 10.1067/mge.2003.292.

  PMID: 12838219 BACKGROUND

• Sangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15.

  PMID: 22595446 DERIVED

Related Links

• KhonKaen University Ethics Committee for Human Research

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Assist. Prof. Apichat Sangchan
• Organization: Khon Kaen University

apichaz@yahoo.com

66850004651

Study Officials

• apichat sangchan, MD

  Department of Medicine. Faculty of Medicine. KhonKaen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 23, 2011
• Results First Posted: December 23, 2011

Record last verified: 2011-11

Locations

TH (1)