Covered Versus Uncovered Biliary Stents for Biliary Malignancies

March 29, 2016 updated by: Rita Conigliaro, MD, Nuovo Ospedale Civile S.Agostino Estense

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41126
        • NOCSAE - Viale Giardini 1355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: covered stents
endoscopic placement of covered biliary stents
Device: covered biliary stents
endoscopic placement of covered biliary stents
Other Names:
  • Taewoong Medical NITI-S Covered
Active Comparator: uncovered biliary stents
endoscopic placement of uncovered biliary stents
Device: uncovered biliary stents
endoscopic placement of uncovered biliary stents
Other Names:
  • Taewoong Medical NITI-S Uncovered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of malignant biliary obstruction
Time Frame: six months
Clinical assessment
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost/effecacy
Time Frame: 6 months
cost and effectiveness of covered versus uncovered biliary stents
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gallbladder in situ
Time Frame: 6 months
Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuovo Ospedale Civile S.Agostino Estense

Investigators

  • Principal Investigator: Rita Conigliaro, MD, Digestive Endoscopy Unit-NOCSAE- Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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