NCT05600803

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 26, 2022

Last Update Submit

November 23, 2023

Conditions

CholangiocarcinomaBile Duct Neoplasms

Outcome Measures

Primary Outcomes (1)

  • detection rate

    detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy

    Until the end of the single-operator cholangioscopy session (up to 20 minutes)

Secondary Outcomes (4)

  • Technical success of cholangioscopy

    Up to 15 minutes from the time the endoscope passes through the oral cavity

  • Technical success of cholangioscopy-guided biopsy

    Until the end of the single-operator cholangioscopy session (up to 20 minutes)

  • Adverse events

    From the start of endoscopy to the end of the study observation period (at least 12 months)

  • Number needed to screen

    From the start of endoscopy to the end of the study observation period (at least 12 months)

Study Arms (1)

DSOC group

Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy.

Procedure: Single-operator cholangioscopy

Interventions

Single-operator cholangioscopyPROCEDURE

SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions

DSOC group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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%)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of biliary tract cancer
  • Presence of distal CBD stricture
  • Bleeding tendency (INR\>1.5 or platelets \<50000 mm3)
  • Contraindications of ERCP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

RECRUITING

Related Publications (7)

  • 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.

    PMID: 23127575BACKGROUND

  • Siddiqui 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.

    PMID: 22178463BACKGROUND

  • Chen 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.

    PMID: 21762903BACKGROUND

  • Cotton 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.

    PMID: 20189503BACKGROUND

  • Imperiale 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.

    PMID: 12050337BACKGROUND

  • Saraiva 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.

    PMID: 34508767BACKGROUND

  • Shin 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.

    PMID: 33865838RESULT

MeSH Terms

Conditions

CholangiocarcinomaBile Duct Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Jong Ho Moon, MD,PhD,FASGE,FJGES

CONTACT

+82-32-62-5094jhmoonsch@gmail.com

Il Sang Shin, MD,PhD

CONTACT

+82-32-62-5094110554@schmc.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FASGE, FJGES

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 1, 2022

Study Start

October 30, 2022

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

KR(1)