Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGermans Trias i Pujol Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.

Be over 18 years of age.

Provide signed informed consent.

Disqualifiers

Age under 18 years.

Lack of availability of signed informed consent.

Impossibility of follow-up.

Trial design

Treatments tested in this trial

  • Cholangiopancreatoscopy

Treatment groups

260 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Germans Trias i Pujol Hospital

Lead sponsor

Spanish Society of Digestive Endoscopy

Collaborator