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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with biliopancreatic pathology fo whom a cholangiopancreatoscopy is performed in hospitals in Spain.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cholangiopancreatoscopy
Procedure/SurgeryDirect cholangiopancreatoscopy by single operator
Treatment groups
260 Participants
are divided into 1 treatment groupGroup A: Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy1 intervention
Trial outcomes
Primary outcomes
1
Timing of cholangioscopy in the management of complex biliary pathologies.
To determine the optimal timing for the use of direct cholangiopancreatoscopy in the management of complex choledocholithiasis and the evaluation of indeterminate biliary strictures.
Time frame
Through study completion, an average of 1 year.Secondary outcomes
1
Diagnostic and therapeutic success rate in cholangioscopy.
To assess whether the effectiveness of the main indications for direct cholangiopancreatoscopy in our setting (complex choledocholithiasis, evaluation of indeterminate strictures) aligns with the currently available evidence. The evaluation will include direct visualization of target lesions, diagnostic accuracy, number and usefulness of the biopsies, diagnosis achieved and stone clearance rate.
Time frame
Through study completion, an average of 1 year2
Incidence of procedure-related adverse events following cholangioscopy.
To evaluate the rate of adverse events associated with direct cholangiopancreatoscopy for its main indications in our setting (complex choledocholithiasis, evaluation of indeterminate strictures) and to assess whether these findings align with the currently available evidence. The evaluation will include post-ERCP pancreatitis, cholangitis, bleeding, perforation, mortality.
Time frame
1 month3
Incremental cost-effectiveness ratio of early cholangioscopy compared to repeated ERCPs.
To compare early cholangioscopy versus repeated ERCPs in both diagnostic and therapeutic indications for complex biliary pathologies, in terms of cost-effectiveness. The analysis will consider procedure-related expenses (ERCPs, Cholangioscopy), hospital admissions and length of hospitalization, ICU admission, number of outpatient visits, need for surgery, imaging studies, success rate and time until complete resolution or end of management.
Time frame
Through study completion, an average of 1 year.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Germans Trias i Pujol Hospital
Lead sponsor
Spanish Society of Digestive Endoscopy
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: