Covered Versus Uncovered Biliary Stents for Biliary Malignancies

Biliary Tract Cancer Clinical Trial

Official title:

Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102984
• Other study ID #: 242/13
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: March 29, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Nuovo Ospedale Civile S.Agostino Estense
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.

Description:

Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree

• not eligible for surgical intervention

• able to provide informed consent

Exclusion Criteria:

• benign biliary obstruction

• previous surgery of the biliary tract

• life expectancy < 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Device:
• covered biliary stents
endoscopic placement of covered biliary stents
• uncovered biliary stents
endoscopic placement of uncovered biliary stents

Locations

Country	Name	City	State
Italy	NOCSAE - Viale Giardini 1355	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Nuovo Ospedale Civile S.Agostino Estense

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Isayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gallbladder in situ	Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used	6 months	Yes
Primary	Relief of malignant biliary obstruction	Clinical assessment	six months	Yes
Secondary	cost/effecacy	cost and effectiveness of covered versus uncovered biliary stents	6 months	Yes