臨床研究等提出・公開システム

Date of registration	June. 07, 2019
Last modified on	June. 01, 2020
Trial ID	jRCTs062190005

Scientific Title	Measurement of liver and splenic stiffness by US-fusion method (MLSStrial)
Public Title	measurement of liver and splenic stiffness by ultrasound (MLSStrial)

Completion date	Mar. 31, 2020
Result actual enrolment	292
Baseline Characteristics	There were total of 292 patients. Because they could not be measured only in the XL probe, 92 people became excluded. 130 patients were assigned to the training set and 70 to the validation set. Was further targeted by such success rate, final training set is 102 people, verification group became 50 people.
Participant flow	Patients were excluded from this study because TE image could not be obtained by the M probe due to severe obesity and after splenectomy.
Adverse events	There was no occurrence of related diseases and adverse events in the study.
Outcome measures	Median spleen volume was 245 mL. Median TE success rates were 76.9 percents and 55.6 percents in the training set and 76.9 percents and 35.0 percents in patients without splenomegaly with and without the new device, respectively. To predict EGVs, the area under the receiver operator characteristic curve was 0.921 and 0.858 with and without the new device, respectively.
Brief summary	By using new device with TE and ultrasound-fusion method, SSM can be examined precisely. Moreover, the risk of bleeding due to EGVs was estimated by the method.
Date of posting of results summaries	June. 01, 2020

Plan to share IPD	Undecided
Plan description	N/A
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs062190005

Contact for Scientific Queries	Name	Hiasa Yoichi
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5308
	E-mail	hiasa@m.ehime-u.ac.jp
Contact for Public Queries	Name	Hirooka Masashi
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5308
	E-mail	masashih@m.ehime-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		June. 01, 2019
Target sample size		200
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	crossover assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who can perform abdominal ultrasonography after obtaining written informed consent (1) Age more than 20 years old (2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
	Exclusion Criteria	(1) Pregnant, unwilling to practice contraception during the study or lactating female (2) After splenectomy (3) After open surgery (4) Inappropriate to participate in this trial
	Age Minimum	20age old over
	Age Maximum	90age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		portal hypertension
Intervention(s)		When liver and spleen stiffness measurement is performed by ultrasound elastography, position of liver and spleen is confirmed using US-fusion method. We will try a self-made attachment to attach the position recognition sensor to use US-fusion.
Health Condition(s) Code		D06.552.494
Intervention(s) Code		E01.370.350.850
Primary Outcome(s)		Success rate of elastography
Secondary Outcome(s)		examination time, examination accuracy, Diagnostic value for esophageal varices

Name of Certified Review Board	Certificated Review board, Ehime University
Address	Shitsukawa, Toon, Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Approval
Date of approval	May. 27, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 01, 2020	(this page)	Changes
1	June. 07, 2019	Detail

List of change history