Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

Official title

National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator

Overview

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.

Interventions

• Procedure Cholangiopancreatoscopy
  Direct cholangiopancreatoscopy by single operator

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Alrajhi S, Barkun A, Adam V, Callichurn K, Martel M, Brewer O, Khashab MA, Forbes N, Almadi MA, Chen YI. Early cholangioscopy-assisted electrohydraulic lithotripsy in difficult biliary stones is cost-effective. Ther Adv Gastroenterol. 2021 Jul 23;14:17562848211031388. doi: 10.1177/17562848211031388. eCollection 2021. PMID 34804204
• Sljivic I, Trasolini R, Donnellan F. Cost-effective analysis of preliminary single-operator cholangioscopy for management of difficult biliary stones. Endosc Int Open. 2022 Sep 14;10(9):E1193-E1200. doi: 10.1055/a-1873-0884. eCollection 2022 Sep. PMID 36118645
• Deprez PH, Garces Duran R, Moreels T, Furneri G, Demma F, Verbeke L, Van der Merwe SW, Laleman W. The economic impact of using single-operator cholangioscopy for the treatment of difficult bile duct stones and diagnosis of indeterminate bile duct strictures. Endoscopy. 2018 Feb;50(2):109-118. doi: 10.1055/s-0043-121268. Epub 2017 Nov 24. PMID 29172216
• Wen LJ, Chen JH, Xu HJ, Yu Q, Liu K. Efficacy and Safety of Digital Single-Operator Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures by Targeted Biopsies: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2020 Sep 2;10(9):666. doi: 10.3390/diagnostics10090666. PMID 32887436
• Turowski F, Hugle U, Dormann A, Bechtler M, Jakobs R, Gottschalk U, Notzel E, Hartmann D, Lorenz A, Kolligs F, Veltzke-Schlieker W, Adler A, Becker O, Wiedenmann B, Burgel N, Troger H, Schumann M, Daum S, Siegmund B, Bojarski C. Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS: results of a multicenter retrospective cohort study. Surg Endosc. 2018 Sep;32(9):3981-3 PMID 29532224
• Korrapati P, Ciolino J, Wani S, Shah J, Watson R, Muthusamy VR, Klapman J, Komanduri S. The efficacy of peroral cholangioscopy for difficult bile duct stones and indeterminate strictures: a systematic review and meta-analysis. Endosc Int Open. 2016 Mar;4(3):E263-75. doi: 10.1055/s-0042-100194. Epub 2016 Feb 4. PMID 27004242
• Kim HJ, Choi HS, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Choi SH. Factors influencing the technical difficulty of endoscopic clearance of bile duct stones. Gastrointest Endosc. 2007 Dec;66(6):1154-60. doi: 10.1016/j.gie.2007.04.033. Epub 2007 Oct 22. PMID 17945223
• Navaneethan U, Njei B, Lourdusamy V, Konjeti R, Vargo JJ, Parsi MA. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan;81(1):168-76. doi: 10.1016/j.gie.2014.09.017. Epub 2014 Nov 1. PMID 25440678

Identifiers

NCT: NCT07064447 · Pl-24-022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗