Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

Sponsor
Germans Trias i Pujol Hospital
Study ID
NCT07064447
Status
Not Yet Recruiting

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Conditions

  • Biliary Stricture
  • Cholangiocarcinoma
  • Cholangiopathy
  • Choledocholithiasis
  • Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cholangiopancreatoscopy — PROCEDURE
    Direct cholangiopancreatoscopy by single operator

Study Details

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.

Key Dates

First listed
Jul 14, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
260 participants (estimated)

Arms

  • Arm: Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy
    Patients with biliopancreatic pathology who undergo cholangiopancreatoscopy, are over 18 years of age, and have signed the informed consent

Primary Outcome Measure

Timing of cholangioscopy in the management of complex biliary pathologies. [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

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