NCT05761496

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
871

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

February 25, 2023

Last Update Submit

November 12, 2024

Conditions

Biliary StrictureStent Stenosis

Keywords

Biliary stricturePlastic stentSelf Expandable Metal stent

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the potency of biliary stents (plastic and metal)

    Time to occurrence of jaundice/cholangitis

    through study completion, an average of 1 year

Interventions

Biliary stents insertionDEVICE

Endoscopic placement of plastic and metal biliary stents

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location

Study Officials

  • Andrea Tringali, MD, PhD

    Fondazione Policlinico Gemelli IRCCS, Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 9, 2023

Study Start

January 7, 2020

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations

IT(1)