UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045281 |
|---|---|
| Receipt number | R000051719 |
| Scientific Title | The impact of the intraoperative intact PTH monitoring and whole PTH monitoring on parathyroidectomy for hyperparathyroidism |
| Date of disclosure of the study information | 2021/08/28 |
| Last modified on | 2021/08/27 13:56:09 |
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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
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
thira@nagoya2.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051719
