CholangiocarcinomaNCT07064447
Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator
An observational study of Cholangiocarcinoma and Cholangiopathy, run by Germans Trias i Pujol Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Cholangiopathy, Biliary Stricture
- What is being tested?
- Cholangiopancreatoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biliopancreatic pathology fo whom a cholangiopancreatoscopy is performed in hospitals in Spain.
Who may be able to join
- Patients undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.
- Be over 18 years of age.
- Provide signed informed consent.
Who cannot join
- Age under 18 years.
- Lack of availability of signed informed consent.
- Impossibility of follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator
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.
Read more
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.
Read the 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.
- Conditions
- Cholangiocarcinoma, Cholangiopathy, Biliary Stricture, Choledocholithiasis, Pancreatic Cancer
- Being tested
- Cholangiopancreatoscopy
- Keywords
- Cholangiopancreatoscopy, indeterminate biliary stricture, choledocholitiasis, pancreatic cancer, cost-effectiveness, algorithm
- Medical subject headings
- Cholangiocarcinoma, Choledocholithiasis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholangiopancreatoscopyProcedure or surgery
Direct cholangiopancreatoscopy by single operator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Cholangiopancreatoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
Diagnostic and therapeutic success rate in cholangioscopy.
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.
Measured: Through study completion, an average of 1 year
Incidence of procedure-related adverse events following cholangioscopy.
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.
Measured: 1 month
Incremental cost-effectiveness ratio of early cholangioscopy compared to repeated ERCPs.
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Responsible party
- Sponsor
- Investigators
- Eloi Nuñez-Garcia, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064447
- Sponsor's protocol ID
- Pl-24-022
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in cholangiopancreatoscopy and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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.
PubMed 34804204Sljivic 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.
PubMed 36118645Deprez 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.
PubMed 29172216Wen 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.
PubMed 32887436Turowski 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.
PubMed 29532224Korrapati 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.
PubMed 27004242Kim 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.
PubMed 17945223Navaneethan 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.
PubMed 25440678
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prospective Registry of Direct Cholangiopancreatoscopy by Single Operator
- ClinicalTrials.gov ID
- NCT07064447
- Acronym / sponsor ID
- Pl-24-022
- Conditions
- Cholangiocarcinoma, Cholangiopathy, Biliary Stricture, Choledocholithiasis, Pancreatic Cancer
- Keywords
- Cholangiopancreatoscopy, indeterminate biliary stricture, choledocholitiasis, pancreatic cancer, cost-effectiveness, algorithm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy | – | Procedure: CholangiopancreatoscopyPatients with biliopancreatic pathology who undergo cholangiopancreatoscopy, are over 18 years of age, and have signed the informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biliopancreatic pathology fo whom a cholangiopancreatoscopy is performed in hospitals in Spain.
Key inclusion criteria (3 listed)
- Patients undergoing cholangiopancreatoscopy at the participating centers from 1 June 2025 will be included.
- Be over 18 years of age.
- Provide signed informed consent.
Key exclusion criteria (3 listed)
- Age under 18 years.
- Lack of availability of signed informed consent.
- Impossibility of follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholangiopancreatoscopyDirect cholangiopancreatoscopy by single operator | Procedure or surgery | Patients with biliopancreatic pathology undergoing cholangiopancreatoscopy |
Primary outcome
Timing of cholangioscopy in the management of complex biliary pathologies.
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 34804204Alrajhi 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.
- Background: PubMed 36118645Sljivic 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.
- Background: PubMed 29172216Deprez 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.
- Background: PubMed 32887436Wen 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.
- Background: PubMed 29532224Turowski 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.
- Background: PubMed 27004242Korrapati 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.
- Background: PubMed 17945223Kim 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.
- Background: PubMed 25440678Navaneethan 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.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in cholangiopancreatoscopy and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eloi Nuñez-Garcia, MD principal investigator
Germans Trias i Pujol Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Cholangiopathy, run by Germans Trias i Pujol Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloi Nuñez-Garcia, MD (+34660396345, enunezg.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of cholangioscopy in the management of complex biliary pathologies. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07064447, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.