Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions

Cholangiocarcinoma Clinical Trial

Official title:

Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600803
• Other study ID #: screeningsoc
• Status: Recruiting
• Start date: October 30, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: November 2023
• Source: Soonchunhyang University Hospital
• Contact: Jong Ho Moon, MD,PhD,FASGE,FJGES
• Phone: +82-32-62-5094
• Email: jhmoonsch[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma

Intervention

Procedure:
• Single-operator cholangioscopy
SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical success of cholangioscopy	successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree	Up to 15 minutes from the time the endoscope passes through the oral cavity
Secondary	Technical success of cholangioscopy-guided biopsy	successful tissue sampling of intraductal superficial lesions under direct visualization	Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Secondary	Adverse events	all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria	From the start of endoscopy to the end of the study observation period (at least 12 months)
Secondary	Number needed to screen	the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients	From the start of endoscopy to the end of the study observation period (at least 12 months)