NCT07064447Not yet recruiting
Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator
National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator
Source: ClinicalTrials.gov · Last updated 14 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 260 (estimated)
- First submitted
- 21 May 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Germans Trias i Pujol Hospital
- NCT number
- NCT07064447
What you commit to
- Study type: Observational
- Planned participants: 260
- From 1 Sept 2025 to the primary completion date, 30 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age under 18 years.
Other
- Lack of availability of signed informed consent.
- Impossibility of follow-up.
Who the study is looking for
- Patients undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.
- Be over 18 years of age.
- Provide signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.