Percutaneous Cholangiopancreatoscopy Registry

NCT ID: NCT05210322

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 679 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Biliary Stones; Cholangiocarcinoma, Intrahepatic; Biliary Stricture; Cholelithiasis; Choledocholithiasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

Percutaneous cholangiopancreatoscopy

Per standard treatment protocol for percutaneous cholangiopancreatoscopy, access will be gained into the biliary system using the biliary tube or into the gallbladder using the cholecystostomy tube. After access has been secured, through a peel-away sheath a Spy Glass Discover Digital Catheter will be introduced. Next, either, the stones will then be removed from the biliary system or gallbladder using a combination of baskets, and lithotripsy equipment as required, or in case of biliary strictures, a clamshell biopsy will be taken from the stricture site as identified on endoscopic visualization and cross-sectional imaging. Further intervention maybe performed for the stricture based on operator preference. After the complete stone removal/ stricture management the cholecystostomy/ biliary tube will be removed after the patient passes a clinical capping trial.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Holly, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00219877

Identifier Type: -

Identifier Source: org_study_id