The Percutaneous Cholangiopancreatoscopy Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Biliary Stones
- Sponsor
- Johns Hopkins University
- Enrollment
- 679
- Locations
- 1
- Primary Endpoint
- Tube free survival
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Tube free survival
Time Frame: Up to 3 years
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.
Secondary Outcomes
- Complication rate(1 month)
- Procedural success(At the time of the procedure)
- Technical success(At the time of the procedure)
- Clinical success(At the time of the procedure)
- Complication rate(At the time of the procedure)