Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

Not yet recruiting

• Conditions: Cholangiocarcinoma; Cholangiopathy; Biliary Stricture; Choledocholithiasis; Pancreatic Cancer

• Registration Number: NCT07064447
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

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.

Detailed Description

Endoscopic procedures, more specifically endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP), remain fundamental in the study and/or treatment of many pancreatic and biliary tract diseases.

However, there are certain situations in which these procedures face limitations, whether due to the characteristics of the pathology itself or the technique's constraints. This is the case, for example, in the evaluation of indeterminate ductal strictures or the management of complex choledocholithiasis, where the diagnostic or therapeutic yield is often suboptimal.

Direct visualization of the biliary and pancreatic ducts has been shown to be a useful and effective alternative in such scenarios. Its safety profile is similar to that of conventional ERCP, with only a slight increase in the incidence of adverse events.

Despite this, the increased costs associated with this technique have led most centers to adopt a stepwise approach in their clinical algorithms. In general, conventional ERCP is used initially, and direct cholangiopancreatoscopy is only considered after several failed ERCPs.

While the economic evidence remains limited, recent studies suggest that early implementation of this technique could be a cost-effective solution, due to its high efficacy and the potential reduction in the total number of procedures required.

In this context, collecting data on the use of direct cholangiopancreatoscopy would be valuable to generate robust conclusions regarding the real-world efficacy and cost-effectiveness of the technique in routine clinical practice data that is currently lacking.

This study aims to objectively assess the real-world use of direct cholangiopancreatoscopy in our setting, to confirm technical, efficacy, and safety data for both its diagnostic and therapeutic indications, and ultimately to perform cost-effectiveness analyses to help determine the optimal point within the clinical algorithm at which this technique should be introduced.

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-09-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Patients undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.
• Be over 18 years of age.
• Provide signed informed consent.

Exclusion Criteria

• Age under 18 years.
• Lack of availability of signed informed consent.
• Impossibility of follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timing of cholangioscopy in the management of complex biliary pathologies.	Through study completion, an average of 1 year.	To determine the optimal timing for the use of direct cholangiopancreatoscopy in the management of complex choledocholithiasis and the evaluation of indeterminate biliary strictures.

Secondary Outcome Measures

Name	Time	Method
Diagnostic and therapeutic success rate in cholangioscopy.	Through study completion, an average of 1 year	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.
Incidence of procedure-related adverse events following cholangioscopy.	1 month	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.
Incremental cost-effectiveness ratio of early cholangioscopy compared to repeated ERCPs.	Through study completion, an average of 1 year.	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.