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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05761496
• Collaborator: (none)
• Enrollment: 750
• Location: 1
• Anticipated Duration (Months): 47.8
• Patients Per Site Per Month: 15.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Biliary Stricture; Stent Stenosis	Device: Biliary stents insertion

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.
• Actual Study Start Date: Jan 7, 2020
• Actual Primary Completion Date: Feb 25, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Outcome Measures

Primary Outcome Measures

1. Evaluation of the potency of biliary stents (plastic and metal) [through study completion, an average of 1 year]

   Time to occurrence of jaundice/cholangitis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli IRCCS	Roma		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tringali Andrea, MD, PhD, Assitant Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05761496
• Other Study ID Numbers: 2767
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tringali Andrea, MD, PhD, Assitant Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS: Biliary stricture; Plastic stent; Self Expandable Metal stent
• Additional relevant MeSH terms: Cholestasis; Constriction, Pathologic

Study Results

No Results Posted as of Mar 9, 2023