UMIN-CTR Clinical Trial

Basic information
Public title	The impact of the intraoperative intact PTH monitoring and whole PTH monitoring on parathyroidectomy for hyperparathyroidism
Acronym	The impact of the intraoperative intact PTH monitoring and whole PTH monitoring on parathyroidectomy for hyperparathyroidism
Scientific Title	The impact of the intraoperative intact PTH monitoring and whole PTH monitoring on parathyroidectomy for hyperparathyroidism
Scientific Title:Acronym	The impact of the intraoperative intact PTH monitoring and whole PTH monitoring on parathyroidectomy for hyperparathyroidism
Region	Japan

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

Objectives
Narrative objectives1	The aim is to make the criteria for the intraoperative intact PTH and whole PTH monitoring during parathyroidectomy and compare the efficacy between these methods.
Basic objectives2	Others
Basic objectives -Others	The other aims are to investigate the ratio of whole PTH in the intact PTH, the difference of measured levels in the plasma and the serum, and the impact of intact PTH and whole PTH monitoring on the persistent and recurrent hyperparathyroidism.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Intact PTH levels, whole PTH levels, calcium levels, phosphorus levels, kidney function, and liver function will be measured during perioperative period.
Key secondary outcomes	Intact PTH levels, whole PTH levels, calcium levels, phosphorus levels, kidney function, liver function, and reoperation due to persistent and recurrent hyperparathyroidism will be investigated within 5 years after operation.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who consent with the enrollment of this study.
Key exclusion criteria	The patients who do not consent with the enrollment of this study.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name TAKAHISA Middle name Last name HIRAMITSU
Organization	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name	Transplant and Endocrine Surgery
Zip code	466-8650
Address	2-9 Myokencho Showaku Nagoya Aichi466-8650 Japan
TEL	+81528321121
Email	thira@nagoya2.jrc.or.jp

Public contact
Name of contact person	1st name TAKAHISA Middle name Last name HIRAMITSU
Organization	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name	Transplant and Endocrine Surgery
Zip code	466-8650
Address	2-9 Myokencho Showaku Nagoya Aichi466-8650 Japan
TEL	+81528321121
Homepage URL
Email	thira@nagoya2.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Institute
Department

Funding Source
Organization	Roche Diagnostics K.K.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Address	2-9 Myokencho Showaku Nagoya Aichi466-8650 Japan
Tel	09058745291
Email	thira@nagoya2.jrc.or.jp

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	2021 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 15 Day
Date of IRB	2021 Year 07 Month 15 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2031 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In the patients who undergo parathyroidectomy for hyperparathyroidism, blood sampling for intact PTH and whole PTH will be added at admission, pre-operation, 5 min, 10mim, 15min, 20 min after the removal of parathyroid glands, and postoperative day1. And at every visit to the outpatient clinic, blood sampling for intact PTH and whole PTH will be added. The persistent and recurrent hyperparathyroidism will be investigated.

Management information
Registered date	2021 Year 08 Month 27 Day
Last modified on	2021 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051719