Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator

NCT07064447 | Not Yet Recruiting DMC

• 1 other identifier: Pl-24-022
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cholangiocarcinoma; Cholangiopathy; Biliary Stricture; Choledocholithiasis; Pancreatic Cancer

Keywords

Cholangiopancreatoscopy; indeterminate biliary stricture; choledocholitiasis; pancreatic cancer; cost-effectiveness; algorithm

Outcome Measures

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.

  Through study completion, an average of 1 year.

Secondary Outcomes (3)

• Diagnostic and therapeutic success rate in cholangioscopy.

  Through study completion, an average of 1 year

• Incidence of procedure-related adverse events following cholangioscopy.

  1 month

• Incremental cost-effectiveness ratio of early cholangioscopy compared to repeated ERCPs.

  Through study completion, an average of 1 year.

Study Arms (1)

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

Procedure: Cholangiopancreatoscopy

Interventions

Cholangiopancreatoscopy PROCEDURE

Direct cholangiopancreatoscopy by single operator

Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biliopancreatic pathology fo whom a cholangiopancreatoscopy is performed in hospitals in Spain.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Spanish Society of Digestive Endoscopy: collaborator

Related Publications (8)

• 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. Therap Adv Gastroenterol. 2021 Jul 23;14:17562848211031388. doi: 10.1177/17562848211031388. eCollection 2021.

  PMID: 34804204 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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):3981-3988. doi: 10.1007/s00464-018-6141-0. Epub 2018 Mar 12.

  PMID: 29532224 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma; Choledocholithiasis; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Eloi Nuñez-Garcia, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloi Nuñez-Garcia, MD

CONTACT

+34660396345; enunezg.germanstrias@gencat.cat

Juan Colán-Hernández, MD-PhD

CONTACT

+34629022059; jacolanh.germanstrias@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 14, 2025
• Study Start: September 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 10 months and ending 2 years after the publication of results.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.