Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

NCT ID: NCT05761496

Last Updated: 2024-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

871 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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Conditions

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Biliary Stricture Stent Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biliary stents insertion

Endoscopic placement of plastic and metal biliary stents

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Tringali Andrea, MD, PhD

Assitant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Tringali, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli IRCCS, Rome, Italy

Locations

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Fondazione Policlinico Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2767

Identifier Type: -

Identifier Source: org_study_id

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