臨床研究等提出・公開システム

Date of registration	June. 11, 2026
Last modified on	June. 11, 2026
Trial ID	jRCT1042260061

Scientific Title	A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Public Title	A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

Contact for Scientific Queries	Name	Okuno Mitsuru
	Affiliation	Matsunami General Hospital
	Address	Dendai 185-1, Kasamatsu-cho, Hashima-gun
	Telephone	+81-58-388-0111
	E-mail	mkobdkl@yahoo.co.jp
Contact for Public Queries	Name	Okuno Mitsuru
	Affiliation	Matsunami General Hospital
	Address	Dendai 185-1, Kasamatsu-cho, Hashima-gun
	Telephone	+81-58-388-0111
	E-mail	mkobdkl@yahoo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 03, 2026
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with unresectable malignant hilar biliary obstruction Patients with a pathological diagnosis of malignancy Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP The criteria for abnormal values are as follows: Total bilirubin > 2 mg/dL AST > 45 IU/L ALT > 45 IU/L ALP > 450 IU/L g-GTP > 75 IU/L Patients undergoing initial bilateral inside plastic stent placement Patients expected to have a prognosis of at least 2 months Patients with Bismuth type II-IV (requiring bilateral biliary drainage) Age > 18 years
	Exclusion Criteria	Patients with concomitant distal biliary obstruction Patients with surgically altered anatomy (excluding Billroth I reconstruction) Patients with severe comorbidities affecting other organs Patients in whom biliary cannulation (transpapillary approach) is not feasible Patients with concomitant duodenal
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Malignant hilar biliary stricture cases
Intervention(s)		Trans-papillary biliary stenting
Health Condition(s) Keyword		Malignant hilar biliary stricture
Intervention(s) Keyword		Trans-papillary biliary stenting
Primary Outcome(s)		Stent patency duration and stent occlusion rates at 30, 60, and 90 days.
Secondary Outcome(s)		Technical and clinical success rates of stent placement Adverse events associated with stent placement Overall survival Details of reintervention at the time of stent occlusion Stent removal success rate Types of stents used during reintervention, and technical and clinical success rates of reintervention Stent patency duration after reintervention

Name of Certified Review Board	Ethics Review Committee of the Graduate School of Medicine, Gifu University
Address	Yanagido 1-1, Gifu city, Gifu
Telephone	+81-58-230-6000
E-Mail	mkobdkl@yahoo.co.jp
Approval Status	Approval
Date of approval	June. 03, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none