Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Calculi

Constriction, Pathologic

Gallstones

Cholelithiasis

Cholecystolithiasis

Choledocholithiasis

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Bile Duct Diseases

Common Bile Duct Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Bile Duct Cancer

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.

Percutaneous cholangiopancreatoscopy

Harjit Singh, MD

Hannatu Bwayili, BS

Tushar Garg, MD

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.

Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy Registry

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.

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

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.

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University
Percutaneous Cholangiopancreatoscopy Registry	NCT05210322	Biliary Stones Cholangiocarcin... Biliary Strictu... Cholelithiasis Choledocholithi...	Percutaneous ch...	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for percutaneous cholangiopancreatoscopy