Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07064447 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 14, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) remain fundamental tools for the diagnosis and treatment of many pancreatobiliary diseases. However, there are situations in which these procedures face limitations, such as the evaluation of indeterminate ductal strictures or the management of complex choledocholithiasis. Direct visualization of the biliary and pancreatic ducts has proven to be a useful and effective alternative in such cases. It also has a safety profile comparable to conventional ERCP, with only a slight increase in the incidence of adverse events. Nevertheless, due to the associated increase in costs, most centers have adopted a stepwise approach in their diagnostic and therapeutic algorithms, using this technique only after multiple ERCPs. Although the evidence is still limited, recent studies suggest that early use of direct cholangiopancreatoscopy could be a cost-effective strategy due to its increased efficacy. In this regard, collecting data on direct cholangiopancreatoscopy would be of interest to generate robust conclusions on cost-effectiveness in routine clinical practice. This study aims to objectively assess the real-world use of direct cholangiopancreatoscopy in our setting, with the goal of confirming technical aspects, efficacy, and safety, and ultimately conducting cost-effectiveness evaluations to determine the optimal point in the algorithm at which this technique should be introduced.
Trial Details
NCT Number NCT07064447
Lead Sponsor Germans Trias i Pujol Hospital
Collaborators: Spanish Society of Digestive Endoscopy
Conditions
(from sponsor)
Cholangiocarcinoma, Cholangiopathy, Biliary Stricture, Choledocholithiasis, Pancreatic Cancer
Related terms Cholangiocarcinoma, Choledocholithiasis, Pancreatic Neoplasms
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov