臨床研究等提出・公開システム

Date of registration	Mar. 17, 2026
Last modified on	Mar. 17, 2026
Trial ID	jRCT1030250817

Scientific Title	Safety of Combined Use of ARISTA AH and AdSpray on the Liver Resection Surface: A Clinical Study
Public Title	A study to evaluate the safety of using a hemostatic agent and an anti-adhesion material together after liver surgery

Contact for Scientific Queries	Name	Okamura Yukiyasu
	Affiliation	Nihon University School of Medicine, Itabashi Hospital
	Address	Ooyaguchikamicho 30-1, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	mitsuka.yusuke@nihon-u.ac.jp
Contact for Public Queries	Name	Mitsuka Yusuke
	Affiliation	Nihon University School of Medicine, Itabashi Hospital
	Address	Ooyaguchikamicho 30-1, Itabashi-ku, Tokyo
	Telephone	+81-3-3972-8111
	E-mail	mitsuka.yusuke@nihon-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 17, 2026
Actual date of first enrollment		Sept. 09, 2024
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet all of the following criteria will be included: 1. Patients with primary or metastatic liver tumors (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or metastatic liver cancer) who are clinically indicated for liver resection based on liver function and tumor characteristics 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 3.Age 18 years or older, regardless of sex
	Exclusion Criteria	Patients meeting any of the following criteria will be excluded: 1. Patients undergoing liver resection requiring vascular or biliary reconstruction 2. Patients with intrahepatic cholangiocarcinoma requiring lymph node dissection 3. Patients with impaired liver function (Child-Pugh class B or C) 4. Patients with tumor invasion to adjacent organs (excluding the gallbladder) 5. Patients with tumor invasion into the inferior vena cava 6. Patients deemed unsuitable for participation in this study by the principal investigator 7. Patients who decline to participate in this study
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		hepatocellular carcinoma and intrahepatic cholangiocarcinoma and metastatic liver cancer
Intervention(s)		Intervention: Application of ARISTA AH followed by AdSpray on the liver resection surface ARISTA AH is applied for hemostasis, followed by application of AdSpray. This study evaluates the safety of applying AdSpray to the liver resection surface, which is not described in the package insert.
Primary Outcome(s)		Incidence of postoperative complications associated with the combined use of a hemostatic agent and an anti-adhesion material on the liver resection surface
Secondary Outcome(s)		Postoperative laboratory abnormalities. WBC, CRP, T-Bil, AST, ALT, Cre, eGFR Imaging findings around the resection surface , scored 0-2 based on severity Adhesion score at repeat hepatectomy

Primary Sponsor	None (investigator-initiated study)

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board, Nihon University School of Medicine, Itabashi Hospital
Address	Ooyaguchikamicho 30-1, Itabashi-ku, Tokyo, Tokyo
Telephone	+81-3-3972-8111
E-Mail	med.itabashi.clinicalresearch@nihon-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 09, 2024

Countries of Recruitment（Except Japan）	none