Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.

Study Overview

• Status: Recruiting
• Conditions: Cholelithiasis; Choledocholithiasis; Biliary Stricture; Cholangiocarcinoma, Intrahepatic; Biliary Stones
• Intervention / Treatment: Procedure: Percutaneous cholangiopancreatoscopy

• Study Type: Observational
• Enrollment (Estimated): 540

Contacts and Locations

• Study Contact: Name: Harjit Singh, MD; Phone Number: 4432872915; Email: hsingh@jhmi.edu
• Study Contact Backup: Name: Hannatu Bwayili, BS; Phone Number: 4439299641; Email: hbwayil1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Harjit Singh, MD; Phone Number: 443-287-2915; Email: hsingh@jhmi.edu
      • Contact: Tushar Garg, MD; Phone Number: 443-287-2916; Email: tgarg3@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with clinical indication for the cholangiopancreatoscopy procedure.

Description

Inclusion Criteria:

• Male or female adults
• 18 years of age and older
• Patients undergoing clinically indicated percutaneous cholangiopancreatoscopy procedure at the Johns Hopkins Hospital or one of the registry sites.
• Willing and able to understand and sign a written informed consent document for the prospective component of the study.

Exclusion Criteria:

• Pregnant women
• Children (< 18 years of age)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tube free survival	Tube free survival will be calculated by estimating the number of patients who can undergo removal of the biliary/ cholecystostomy tube after the PCPS procedure until their last IR clinical follow-up or death.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success is defined as successful access with cholangioscope and visualization of the stones or a lesion to be biopsied.	At the time of the procedure
Procedural success	Procedural success in patients with calculi, is defined as either a) visualization of stones with at least partial stone removal, or b) visualization of biliary system demonstrating no need for further investigation; in patients with biliary stricture, defined as a) obtaining tissue for biopsy or b) successfully visualize and complete or partial treatment of the stricture.	At the time of the procedure
Clinical success	Clinical success is defined as improvement in clinical symptoms (e.g., abdominal pain, fever, jaundice, nausea and vomiting), laboratory values and/or imaging findings.	At the time of the procedure
Complication rate	Complication rate will be calculated by recording the adverse events that occur during the procedure in accordance with the Society of Interventional Radiology Classification System.	At the time of the procedure
Complication rate	Complication rate will be calculated by recording the adverse events that occur after the procedure in accordance with the Society of Interventional Radiology Classification System.	1 month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Harjit Singh, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Calculi; Cholangiocarcinoma; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: IRB00219877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes