Clinical trial · Observational
Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator
National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiopathy | — | UNRESOLVED | — |
| Choledocholithiasis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholangiopancreatoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy
- description
- Patients with biliopancreatic pathology who undergo cholangiopancreatoscopy, are over 18 years of age, and have signed the informed consent
- interventionNames
- Procedure: Cholangiopancreatoscopy
Primary outcomes (1)
- measure
- Timing of cholangioscopy in the management of complex biliary pathologies.
- timeFrame
- Through study completion, an average of 1 year.
- description
- 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 outcomes (3)
- measure
- Diagnostic and therapeutic success rate in cholangioscopy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDAlrajhi 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
- BACKGROUNDSljivic 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
- BACKGROUNDDeprez 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
- BACKGROUNDWen 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
- BACKGROUNDTurowski 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
- BACKGROUNDKorrapati 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.