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Active, Not Recruiting

NCT Number: NCT05210322

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Biliary Stones Adenocarcinoma Bile Duct Diseases Biliary Stricture Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholangiocarcinoma, Intrahepatic Cholecystolithiasis Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Technical success

    Time frame: At the time of the procedure

    Technical success is defined as successful access with cholangioscope and visualization of the stones or a lesion to be biopsied.

  2. Procedural success

    Time frame: At the time of the procedure

    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.

  3. Clinical success

    Time frame: At the time of the procedure

    Clinical success is defined as improvement in clinical symptoms (e.g., abdominal pain, fever, jaundice, nausea and vomiting), laboratory values and/or imaging findings.

  4. Complication rate

    Time frame: At the time of the procedure

    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.

  5. Complication rate

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

The Percutaneous Cholangiopancreatoscopy Registry

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 27, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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