Biliary StonesNCT05210322
Percutaneous Cholangiopancreatoscopy Registry
An observational study of Biliary Stones and Cholangiocarcinoma, Intrahepatic, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stones, Cholangiocarcinoma, Intrahepatic, Biliary Stricture
- What is being tested?
- Percutaneous cholangiopancreatoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 679 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 30 Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients with clinical indication for the cholangiopancreatoscopy procedure.
Who may be able to join
- 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.
Who cannot join
- Pregnant women
- Children (< 18 years of age)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Biliary Stones, Cholangiocarcinoma, Intrahepatic, Biliary Stricture, Cholelithiasis, Choledocholithiasis
- Being tested
- Percutaneous cholangiopancreatoscopy
- Medical subject headings
- Cholecystolithiasis, Cholangiocarcinoma, Cholelithiasis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous cholangiopancreatoscopyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (5)
Technical success
Technical success is defined as successful access with cholangioscope and visualization of the stones or a lesion to be biopsied.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StonesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 679 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Holly, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210322
- Sponsor's protocol ID
- IRB00219877
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Percutaneous Cholangiopancreatoscopy Registry
- ClinicalTrials.gov ID
- NCT05210322
- Acronym / sponsor ID
- IRB00219877
- Conditions
- Biliary Stones, Cholangiocarcinoma, Intrahepatic, Biliary Stricture, Cholelithiasis, Choledocholithiasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with clinical indication for the cholangiopancreatoscopy procedure.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women
- Children (< 18 years of age)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous cholangiopancreatoscopyPer 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. | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
Technical success
Time frame: At the time of the procedure
Procedural success
Time frame: At the time of the procedure
Clinical success
Time frame: At the time of the procedure
Complication rate
Time frame: At the time of the procedure
Complication rate
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Holly, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stones and Cholangiocarcinoma, Intrahepatic, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tube free survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.