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Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

NCT02930252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2016-10-12

No results posted yet for this study

Summary

The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.

Conditions

  • Biliary Cancer

Interventions

DEVICE

Niti-S Biliary ComVi Stent

Endoscopic placement of biliary fully covered metal stents

DEVICE

Niti-S stent (D type)

Endoscopic placement of biliary uncovered metal stent

Sponsors & Collaborators

  • Ospedali Riuniti Marche Nord, Pesaro, Italy

    collaborator UNKNOWN

  • NOCSAE Hospital, Modena, Italy

    collaborator UNKNOWN

  • University of Siena, Italy

    collaborator UNKNOWN

  • Papa Giovanni XXIII Hospital

    collaborator OTHER

  • Azienda USL 1 Imperiese

    lead OTHER

Principal Investigators

  • Massimo Conio, MD · General Hospital Sanremo, Sanremo, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930252 on ClinicalTrials.gov