Percutaneous Cholangiopancreatoscopy Registry

Cholelithiasis Clinical Trial

Official title:

The Percutaneous Cholangiopancreatoscopy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210322
• Other study ID #: IRB00219877
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: Harjit Singh, MD
• Phone: 4432872915
• Email: hsingh[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Biliary Stones
• Biliary Stricture
• Cholangiocarcinoma
• Cholangiocarcinoma, Intrahepatic
• Cholecystolithiasis
• Choledocholithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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