臨床研究等提出・公開システム

Japanese

Date of registration	May. 08, 2024
Last modified on	Jan. 27, 2025
Trial ID	jRCT1032240067

Scientific Title	A randomized controlled trial of superior understanding of puncture reliability measurement in endoscopic ultrasound-guided tissue acquisition for pancreatic tumors using puncture needles with different tip geometries (SUPREME-TA study)
Public Title	A RCT of evaluating performance of puncture needles in EUS-TA for pancreatic tumors (SUPREME-TA study)

Contact for Scientific Queries	Name	Hiroshi Ohyama
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	ohyama.hiroshi@chiba-u.jp
Contact for Public Queries	Name	Hiroshi Ohyama
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	ohyama.hiroshi@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 08, 2024
Actual date of first enrollment
Target sample size		42
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	crossover assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet all of the following conditions are eligible 1) Persons who are 20 years of age or older at the time of obtaining consent 2) Patients with pancreatic mass lesions eligible for EUS-TA 3) Patients who have been fully informed of the study and given written consent of their own free will based on a thorough understanding of the study.
	Exclusion Criteria	Patients who meet any of the following conditions are not eligible 1) ECOG Performance Status 3 or higher 2) Bleeding risk with HAS-BLED score of 3 or higher or platelet count less than 50,000/mm3 3) Receiving two or more antithrombotic agents 4) Presence of a pancreatic mass undetectable by EUS 5) Pregnancy 6) Refusal to participate 7) Patients deemed by the study investigator or sub-investigator to be unsuitable for the safe conduct of this study.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic tumors
Intervention(s)		The order of puncture needles to be used will be randomly assigned in endoscopic ultrasound-guided tissue sampling (EUS-TA) of pancreatic mass lesions as follows: (1) 1st: novel puncture needle (Century Medical, Trident), 2nd: conventional puncture needle (Boston Scientific, Acquire S) (2) 1st: conventional puncture needle, 2nd: novel puncture needle
Health Condition(s) Keyword		Pancreatic Neoplasms
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percentage of tissue scores of 5 for both conventional and novel puncture needle specimens, following a previous report that defined a tissue score of 5 as one of high quality and sufficient for histological assessment (total tissue sample > x10 power field in length)
Secondary Outcome(s)		-Tissue area of each specimen obtained with the conventional and novel puncture needle -Percentage of tumor cells in each of the conventional and novel puncture needles -Blood contamination rate of conventional and novel puncture needles -Puncture performance of the conventional and novel puncture needles -Treatment time for the conventional and novel puncture needles -Frequency of adverse events after testing with the conventional and novel puncture needles

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Chiba University Hospital
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, Chiba, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	May. 01, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 27, 2025	(this page)	Changes
1	May. 08, 2024	Detail

List of change history