臨床研究等提出・公開システム

Scientific Title	Utility of methylene blue in surgery for primary hyperparathyroidism ( Methylene blue in surgery for hyperparathyroidism)
Public Title	Utility of methylene blue in surgery for primary hyperparathyroidism ( Methylene blue in surgery for hyperparathyroidism)

Contact for Scientific Queries	Name	Obayashi Sayaka
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma, JAPAN
	Telephone	+81-27-220-8224
	E-mail	sayakaobayashi@gmail.com
Contact for Public Queries	Name	Obayashi Sayaka
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma, JAPAN
	Telephone	+81-27-220-8224
	E-mail	sayakaobayashi@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 01, 2000
Actual date of first enrollment		Oct. 11, 2000
Target sample size		200
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	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Cases with hyperparathyroidism who underwent surgery
	Exclusion Criteria	Patients with a history of hypersensitivity to the ingredients of this drug, phenothiazine compounds and analogs.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary and secondory parathyroidism
Intervention(s)		Methylene blue (5 mg/kg) is infused intravenously in 30 minutes immediately after introduction of general anesthesia intraoperatively.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Intraoperative identification rate of parathyroid
Secondary Outcome(s)		Safety

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, , Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 13, 2019

Secondary ID(s)	UMIN 000031174
Issuing Authority	UMIN Clinical Trial Registry (UMIN-CTR)

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history