臨床研究等提出・公開システム

Date of registration	April. 28, 2026
Last modified on	April. 28, 2026
Trial ID	jRCT1030260094

Scientific Title	Utility of Cholangioscopy After Stone Removal for Common Bile Duct Stones in Patients with Surgically Altered Anatomy: A Single-Center Prospective Exploratory Study
Public Title	Utility of Cholangioscopy After Stone Removal for Common Bile Duct Stones in Patients with Surgically Altered Anatomy

Contact for Scientific Queries	Name	Watanabe Masafumi
	Affiliation	Kitasato University Hospital
	Address	1-15-1 Kitasato Minami Sagamihara Kanagawa
	Telephone	+81-42-778-8111
	E-mail	m.wata@kitasato-u.ac.jp
Contact for Public Queries	Name	Watanabe Masafumi
	Affiliation	Kitasato University Hospital
	Address	1-15-1 Kitasato Minami Sagamihara Kanagawa
	Telephone	+81-42-778-8111
	E-mail	m.wata@kitasato-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 28, 2026
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients in whom common bile duct stones were identified on pre-procedural imaging (computed tomography, magnetic resonance cholangiopancreatography, ultrasonography, endoscopic ultrasonography, or balloon enteroscopy-assisted ERCP) and who were considered to require endoscopic stone removal. Patients with surgically altered anatomy (excluding Billroth I reconstruction). Patients with a distal bile duct diameter >=8 mm. Patients with a modified American Society of Anesthesiologists physical status (mASA-PS) classification of II or lower. Patients aged >=18 years who provided written informed consent to participate in the study.
	Exclusion Criteria	Patients in whom discontinuation of antithrombotic agents was considered difficult. Patients with cholangitis, severe jaundice (total bilirubin >5 mg/dL), or pancreatitis. Patients in whom single-session stone removal was considered difficult, including those with stacked stones, stones >15 mm in diameter, Mirizzi syndrome, or concomitant biliary stricture. Patients with a history of pancreatitis following balloon enteroscopy-assisted ERCP (BE-ERCP). Patients who were pregnant or possibly pregnant. Patients who were deemed unsuitable for participation in this study by the principal investigator or sub-investigators for medical or safety reasons.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Common bile duct stone
Intervention(s)		Use of cholangioscopy to confirm residual stones after stone removal
Health Condition(s) Code		D042882
Primary Outcome(s)		Detection rate of residual stones by cholangioscopy
Secondary Outcome(s)		BE-ERCP-related adverse events

Primary Sponsor	None

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kitasato University Institutional Ethics Committee
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa, Kanagawa, Kanagawa
Telephone	+81-42-778-8111
E-Mail	rinrib@med.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	April. 27, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none