Percutaneous Cholangiopancreatoscopy Registry

NCT05210322 | Active Not Recruiting FDA Device

• 1 other identifier: IRB00219877
• Study Type: observational
• Target: 679
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Technical success

  At the time of the procedure

• Procedural success

  At the time of the procedure

• Clinical success

  At the time of the procedure

• Complication rate

  At the time of the procedure

• Complication rate

  1 month

Interventions

Percutaneous cholangiopancreatoscopy PROCEDURE

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.

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

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

You may qualify if:

• Male or female adults
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cholecystolithiasis; Cholangiocarcinoma; Cholelithiasis; Choledocholithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Holly, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)