Skip to main content
OpenTrials
Completed

NCT Number: NCT02102984

Covered Versus Uncovered Biliary Stents for Biliary Malignancies

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NOCSAE - Viale Giardini 1355

Modena, 41126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

covered biliary stents

Device

endoscopic placement of covered biliary stents

Other names: Taewoong Medical NITI-S Covered

uncovered biliary stents

Device

endoscopic placement of uncovered biliary stents

Other names: Taewoong Medical NITI-S Uncovered

Primary outcomes

  1. Relief of malignant biliary obstruction

    Time frame: six months

    Clinical assessment

Secondary outcomes

  1. cost/effecacy

    Time frame: 6 months

    cost and effectiveness of covered versus uncovered biliary stents

Other outcomes

  1. gallbladder in situ

    Time frame: 6 months

    Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used

Sponsors and collaborators

Lead sponsor

Nuovo Ospedale Civile S.Agostino Estense

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.