Clinical trial NCT05600803: Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions
Official title: Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Bile Duct Neoplasms
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 236
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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%)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection rate
timeFrame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
Secondary outcomes:
measure: Technical success of cholangioscopy
timeFrame: Up to 15 minutes from the time the endoscope passes through the oral cavity
measure: Technical success of cholangioscopy-guided biopsy
timeFrame: Until the end of the single-operator cholangioscopy session (up to 20 minutes)
measure: Adverse events
timeFrame: From the start of endoscopy to the end of the study observation period (at least 12 months)
measure: Number needed to screen
timeFrame: From the start of endoscopy to the end of the study observation period (at least 12 months)
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
Study officials:
References:
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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.
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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/j.gie.2021.03.997. Epub 2021 Apr 15.