Covered Versus Uncovered Biliary Stents for Biliary Malignancies
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 30, 2016
March 1, 2016
1.4 years
March 26, 2014
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relief of malignant biliary obstruction
Clinical assessment
six months
Secondary Outcomes (1)
cost/effecacy
6 months
Other Outcomes (1)
gallbladder in situ
6 months
Study Arms (2)
covered stents
ACTIVE COMPARATORendoscopic placement of covered biliary stents
uncovered biliary stents
ACTIVE COMPARATORendoscopic placement of uncovered biliary stents
Interventions
endoscopic placement of covered biliary stents
endoscopic placement of uncovered biliary stents
Eligibility Criteria
You may qualify if:
- adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree
- not eligible for surgical intervention
- able to provide informed consent
You may not qualify if:
- benign biliary obstruction
- previous surgery of the biliary tract
- life expectancy \< 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NOCSAE - Viale Giardini 1355
Modena, 41126, Italy
Related Publications (2)
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.
PMID: 23617653BACKGROUNDConio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11.
PMID: 29653120DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Conigliaro, MD
Digestive Endoscopy Unit-NOCSAE- Modena
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief - Endoscopy Unit
Study Record Dates
First Submitted
March 26, 2014
First Posted
April 3, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
March 30, 2016
Record last verified: 2016-03