Back to resultsCovered Versus Uncovered Biliary Stents for Biliary Malignancies
Primary Purpose
Biliary Tract Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
covered biliary stents
uncovered biliary stents
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
Eligibility Criteria
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
Sites / Locations
- NOCSAE - Viale Giardini 1355
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
covered stents
uncovered biliary stents
Arm Description
endoscopic placement of covered biliary stents
endoscopic placement of uncovered biliary stents
Outcomes
Primary Outcome Measures
Relief of malignant biliary obstruction
Clinical assessment
Secondary Outcome Measures
cost/effecacy
cost and effectiveness of covered versus uncovered biliary stents
Full Information
NCT ID
NCT02102984
First Posted
March 26, 2014
Last Updated
March 29, 2016
Sponsor
Nuovo Ospedale Civile S.Agostino Estense
1. Study Identification
Unique Protocol Identification Number
NCT02102984
Brief Title
Covered Versus Uncovered Biliary Stents for Biliary Malignancies
Official Title
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nuovo Ospedale Civile S.Agostino Estense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
covered stents
Arm Type
Active Comparator
Arm Description
endoscopic placement of covered biliary stents
Arm Title
uncovered biliary stents
Arm Type
Active Comparator
Arm Description
endoscopic placement of uncovered biliary stents
Intervention Type
Device
Intervention Name(s)
covered biliary stents
Other Intervention Name(s)
Taewoong Medical NITI-S Covered
Intervention Description
endoscopic placement of covered biliary stents
Intervention Type
Device
Intervention Name(s)
uncovered biliary stents
Other Intervention Name(s)
Taewoong Medical NITI-S Uncovered
Intervention Description
endoscopic placement of uncovered biliary stents
Primary Outcome Measure Information:
Title
Relief of malignant biliary obstruction
Description
Clinical assessment
Time Frame
six months
Secondary Outcome Measure Information:
Title
cost/effecacy
Description
cost and effectiveness of covered versus uncovered biliary stents
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
gallbladder in situ
Description
Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Conigliaro, MD
Organizational Affiliation
Digestive Endoscopy Unit-NOCSAE- Modena
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOCSAE - Viale Giardini 1355
City
Modena
ZIP/Postal Code
41126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23617653
Citation
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.
Results Reference
background
PubMed Identifier
29653120
Citation
Conio 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.
Results Reference
derived
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Covered Versus Uncovered Biliary Stents for Biliary Malignancies
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