UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of methylene blue in surgery for primary hyperparathyroidism
Title of the study (Brief title)	Methylene blue in surgery for hyperparathyroidism
Region	Japan

Condition
Condition	Hyperparathyroidism
Classification by specialty	Endocrine surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the efficiency of methylene blue in surgery for hyperparathyroidism.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification rate for hyperparathyroid glands.
Key secondary outcomes	safty, time for surgery, blood loss, hospital stay, complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	methylene blue
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases with hyperparathyroidism who underwent surgery
Key exclusion criteria	Patients who do not give their informed consent.
Target sample size	200

Research contact person
Name of lead principal investigator	Takaaki Fujii
Organization	Graduate School of Medicine, Gunma University
Division name	Division of breast and endocrine surgery
Address	3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL	027-220-7111
Email	ftakaaki@gunma-u.ac.jp

Public contact
Name of contact person	Takaaki Fujii
Organization	Same as above
Division name	Same as above
Address	Same as above
TEL	027-220-7111
Homepage URL
Email	ftakaaki@gunma-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Gunma University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Gunma University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2000 Year 10 Month 01 Day
Anticipated trial start date	2000 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 06 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035596