Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. (PROTESIED)

March 7, 2023 updated by: Tringali Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.

Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Gemelli IRCCS
        • Contact:

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring for the first time drainage of malignant distal biliary stricture

Description

Inclusion Criteria:

  • Malignant distal biliary stricture
  • Need for Palliative and pre-operative biliary drainage
  • Age > 18
  • Signature of the informed consent

Exclusion Criteria:

  • Previous endoscopic/radiological biliary drainage
  • Stricture close to the main hepatic confluence(< 2 cm)
  • Duodenal stenosis
  • Post- surgical altered anatomy
  • Benign disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the potency of biliary stents (plastic and metal)
Time Frame: through study completion, an average of 1 year
Time to occurrence of jaundice/cholangitis
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 (Actual)

January 7, 2020

Primary Completion (Actual)

February 25, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2767

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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