Endoscopy and Primary Sclerosing Cholangitis

NCT06686810 | Completed

• 1 other identifier: 3893
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Sclerosing Cholangitis (PSC) is a chronic, cholestatic, immune-mediated liver disease characterized by segmental inflammation, fibrosis and destruction of the intra and / or extrahepatic biliary tree. Patients suffering from PSC can develop biliary strictures and symptoms (jaundice, itching, cholangitis) requiring endoscopic therapy by Endoscopic Retrograde Cholangiopancreatography (ERCP). ERCP can play an important role in symptoms control, cholangiocarcinoma diagnosis. PSC can lead to liver failure and subsequent need for liver transplantation, ERCP can therefore delay the time for liver transplantation. With this work the investigators want to report our thirty years of experience in the endoscopic treatment of PSC.

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

ERCP; Primary sclerosis cholangitis; biliary stricture; dominant biliary stricture; liver transplantation; balloon dilatation; cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Effectiveness of long-term endoscopic treatment

  PSC can lead to liver failure and need for liver transplantation. Endoscopic therapy can have a positive impact to delay the need for liver transplantation

  From Enrollment to the last follow-up, 3 years

Secondary Outcomes (3)

• Need for Endoscopic retreatment

  From Enrollment to the last follow-up, 3 years

• Occurrence of Cholangiocarcinoma

  From Enrollment to the last follow-up, 3 years

• Adverse events

  From Enrollment to the last follow-up, 3 years

Study Arms (1)

Patients undergoing Endoscopic Retrograde CholangioPancreatyopgraphy for PSC

Patients undergoing Endoscopic Retrograde CholangioPancreatyopgraphy (ERCP) to dilate dominant biliary strictures related to Primary Sclerosing cholangitis (PSC)

Procedure: Endoscopic Retrogradade CholangioPancreatography (ERCP)

Interventions

Endoscopic Retrogradade CholangioPancreatography (ERCP) PROCEDURE

ERCP is an endoscopic therapeutic procedure to drain the bile ducts in case of stones or biliary strictures that can be treated by balloon dilatation or stents (plastic or metal) insertion

Patients undergoing Endoscopic Retrograde CholangioPancreatyopgraphy for PSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from primary sclerosis cholangitis and dominant biliary strictures with jaundice, cholangitis, suspicious of malignancy requiring endoscopic biliary drainage (balloon dilatation, scenting) and stricture sampling by ERCP

You may qualify if:

• Patients diagnosed with PSC and biliary tract stenosis with indication for endoscopic treatment.

You may not qualify if:

• Patients with unclear diagnosis of PSC.
• Patients ineligible for endoscopic therapy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Endoscopia Digestiva

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Andrea Tringali, MD, PhD

  Fondazione Policlinico A. Gemelli IRCCS Roma, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: July 1, 2021
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IT (1)