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Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

NCT ID: NCT05600803

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-30

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Cholangiocarcinoma Bile Duct Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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DSOC group

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

Single-operator cholangioscopy

Intervention Type PROCEDURE

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

Interventions

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Single-operator cholangioscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Aged \> 18 years
2. Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)
3. Patients who undergo ERCP for confirmation of CBD clearance
4. Dilated common bile duct (\> 10 mm)
5. Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation

Exclusion Criteria

1. Presence of biliary tract cancer
2. Presence of distal CBD stricture
3. Bleeding tendency (INR\>1.5 or platelets \<50000 mm3)
4. Contraindications of ERCP
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Moon

MD, PhD, FASGE, FJGES

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Ho Moon, MD,PhD,FASGE,FJGES

Role: CONTACT

[email protected]
+82-32-62-5094

Il Sang Shin, MD,PhD

Role: CONTACT

[email protected]
+82-32-62-5094

Facility Contacts

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Jong Ho Moon, MD, PhD, FASGE, FJGES

Role: primary

[email protected]
+82-32-621-5094

Il Sang Shin, MD, PhD

Role: backup

[email protected]
+82-32-62-5094

References

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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.

Reference Type BACKGROUND
PMID: 23127575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22178463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21762903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20189503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12050337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34508767 (View on PubMed)

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.

Reference Type RESULT
PMID: 33865838 (View on PubMed)

Other Identifiers

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screeningsoc

Identifier Type: -

Identifier Source: org_study_id