CholangiocarcinomaNCT05600803
Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions
An observational study of Cholangiocarcinoma and Bile Duct Neoplasms, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Bile Duct Neoplasms
- What is being tested?
- Single-operator cholangioscopy
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2022to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We plan to recruit a total of 239 patients, assuming that the detection rate of neoplastic bile duct is about 3.5% by referring to the preceding literature. (one-sample inference for binomial proportions, one-sided test, significance 5%, power 80%)
Who may be able to join
- Aged > 18 years
- Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
- Patients who undergo ERCP for confirmation of CBD clearance
- Dilated common bile duct (> 10 mm)
- Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation
Who cannot join
- Presence of biliary tract cancer
- Presence of distal CBD stricture
- Bleeding tendency (INR>1.5 or platelets <50000 mm3)
- Contraindications of ERCP
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Jong Ho Moon, MD, PhD, FASGE, FJGES, +82-32-621-5094, jhmoonsch@gmail.com
Il Sang Shin, MD, PhD, +82-32-62-5094, 110554@schmc.ac.kr
About this study
Official title: Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones
This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.
Read the detailed description
It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma, Bile Duct Neoplasms
- Being tested
- Single-operator cholangioscopy
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-operator cholangioscopyProcedure or surgery
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions
| Study group | Role | What they receive |
|---|---|---|
| DSOC group | Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy. Receives: Procedure: Single-operator cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate
detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy
Measured: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Secondary outcomes (4)
Technical success of cholangioscopy
successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree
Measured: Up to 15 minutes from the time the endoscope passes through the oral cavity
Technical success of cholangioscopy-guided biopsy
successful tissue sampling of intraductal superficial lesions under direct visualization
Measured: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Adverse events
all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria
Measured: From the start of endoscopy to the end of the study observation period (at least 12 months)
Number needed to screen
the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients
Measured: From the start of endoscopy to the end of the study observation period (at least 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start30 Oct 2022
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Moon, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600803
- Sponsor's protocol ID
- screeningsoc
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By sharing and conducting research, we try to share pain and optimize performance through cooperation. Details have not been decided yet.
Publications
Moon JH, Terheggen G, Choi HJ, Neuhaus H. Peroral cholangioscopy: diagnostic and therapeutic applications. Gastroenterology. 2013 Feb;144(2):276-282. doi: 10.1053/j.gastro.2012.10.045. Epub 2012 Nov 2. No abstract available.
PubMed 23127575Siddiqui AA, Mehendiratta V, Jackson W, Loren DE, Kowalski TE, Eloubeidi MA. Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection. Clin Gastroenterol Hepatol. 2012 May;10(5):466-71; quiz e48. doi: 10.1016/j.cgh.2011.12.021. Epub 2011 Dec 16.
PubMed 22178463Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
PubMed 21762903Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Results of screening colonoscopy among persons 40 to 49 years of age. N Engl J Med. 2002 Jun 6;346(23):1781-5. doi: 10.1056/NEJM200206063462304.
PubMed 12050337Saraiva MM, Ribeiro T, Ferreira JPS, Boas FV, Afonso J, Santos AL, Parente MPL, Jorge RN, Pereira P, Macedo G. Artificial intelligence for automatic diagnosis of biliary stricture malignancy status in single-operator cholangioscopy: a pilot study. Gastrointest Endosc. 2022 Feb;95(2):339-348. doi: 10.1016/j.gie.2021.08.027. Epub 2021 Sep 8.
PubMed 34508767Shin IS, Moon JH, Lee YN, Kim HK, Lee TH, Yang JK, Cha SW, Cho YD, Park SH. Use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones (with videos). Gastrointest Endosc. 2021 Oct;94(4):776-785. doi: 10.1016/j.gie.2021.03.997. Epub 2021 Apr 15.
PubMed 33865838Shin IS, Moon JH, Lee YN, Park JW, Chung JC, Kim HK, Lee TH, Yang JK, Cho YD, Park SH. Diagnostic Utility of Digital Single-Operator Cholangioscopy for Risk-Enriched Detection and Surveillance of Intraductal Neoplasms of the Bile Duct: SPY-SCREEN Study (with Videos). Dig Dis Sci. 2026 Apr 27. doi: 10.1007/s10620-026-09863-0. Online ahead of print.
PubMed 42043470
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones
- ClinicalTrials.gov ID
- NCT05600803
- Acronym / sponsor ID
- screeningsoc
- Conditions
- Cholangiocarcinoma, Bile Duct Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 1 Nov 2022 (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.
This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.
Detailed description
It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSOC group | – | Procedure: Single-operator cholangioscopyStudy subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit a total of 239 patients, assuming that the detection rate of neoplastic bile duct is about 3.5% by referring to the preceding literature. (one-sample inference for binomial proportions, one-sided test, significance 5%, power 80%)
Key inclusion criteria (5 listed)
- Aged > 18 years
- Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
- Patients who undergo ERCP for confirmation of CBD clearance
- Dilated common bile duct (> 10 mm)
- Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation
Key exclusion criteria (4 listed)
- Presence of biliary tract cancer
- Presence of distal CBD stricture
- Bleeding tendency (INR>1.5 or platelets <50000 mm3)
- Contraindications of ERCP
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 |
|---|---|---|
| Single-operator cholangioscopySpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions | Procedure or surgery | DSOC group |
Primary outcome
detection rate
Time frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy
4 secondary outcomes
Technical success of cholangioscopy
Time frame: Up to 15 minutes from the time the endoscope passes through the oral cavity
Technical success of cholangioscopy-guided biopsy
Time frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Adverse events
Time frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
Number needed to screen
Time frame: From the start of endoscopy to the end of the study observation period (at least 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 23127575Moon JH, Terheggen G, Choi HJ, Neuhaus H. Peroral cholangioscopy: diagnostic and therapeutic applications. Gastroenterology. 2013 Feb;144(2):276-282. doi: 10.1053/j.gastro.2012.10.045. Epub 2012 Nov 2. No abstract available.
- Background: PubMed 22178463Siddiqui AA, Mehendiratta V, Jackson W, Loren DE, Kowalski TE, Eloubeidi MA. Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection. Clin Gastroenterol Hepatol. 2012 May;10(5):466-71; quiz e48. doi: 10.1016/j.cgh.2011.12.021. Epub 2011 Dec 16.
- Background: PubMed 21762903Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Background: PubMed 12050337Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Results of screening colonoscopy among persons 40 to 49 years of age. N Engl J Med. 2002 Jun 6;346(23):1781-5. doi: 10.1056/NEJM200206063462304.
- Background: PubMed 34508767Saraiva MM, Ribeiro T, Ferreira JPS, Boas FV, Afonso J, Santos AL, Parente MPL, Jorge RN, Pereira P, Macedo G. Artificial intelligence for automatic diagnosis of biliary stricture malignancy status in single-operator cholangioscopy: a pilot study. Gastrointest Endosc. 2022 Feb;95(2):339-348. doi: 10.1016/j.gie.2021.08.027. Epub 2021 Sep 8.
- Results publication: PubMed 33865838Shin IS, Moon JH, Lee YN, Kim HK, Lee TH, Yang JK, Cha SW, Cho YD, Park SH. Use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones (with videos). Gastrointest Endosc. 2021 Oct;94(4):776-785. doi: 10.1016/j.gie.2021.03.997. Epub 2021 Apr 15.
- Derived from this study: PubMed 42043470Shin IS, Moon JH, Lee YN, Park JW, Chung JC, Kim HK, Lee TH, Yang JK, Cho YD, Park SH. Diagnostic Utility of Digital Single-Operator Cholangioscopy for Risk-Enriched Detection and Surveillance of Intraductal Neoplasms of the Bile Duct: SPY-SCREEN Study (with Videos). Dig Dis Sci. 2026 Apr 27. doi: 10.1007/s10620-026-09863-0. Online ahead of print.
- Individual participant dataSharing planned: Undecided. By sharing and conducting research, we try to share pain and optimize performance through cooperation. Details have not been decided yet.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Bile Duct Neoplasms, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Ho Moon, MD,PhD,FASGE,FJGES (+82-32-62-5094, jhmoonsch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate (time frame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)). 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 NCT05600803, 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 27 Nov 2023.