UMIN-CTR Clinical Trial

Basic information
Public title	Endoscopic surgery for thyroid and parathyroid
Acronym	Endoscopic surgery for thyroid and parathyroid
Scientific Title	Endoscopic surgery for thyroid and parathyroid
Scientific Title:Acronym	Endoscopic surgery for thyroid and parathyroid
Region	Japan

Condition
Condition	benign thyroid nodule, Graves disease, hyperparathyroidism
Classification by specialty	Endocrine surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify safety and efficacy of endoscopic surgery for thyroid and parathyroid.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	therapeutic efficacy of surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	endoscopic surgery
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients, who will have elective surgery for benign thyroid nodule or Graves disease or primary hyperparathyroidism.
Key exclusion criteria	Patients, who had neck surgery.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Kosho Middle name Last name Yamanouchi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Surgery
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7316
Email	ymanouch@gk9.so-net.ne.jp

Public contact
Name of contact person	1st name Kosho Middle name Last name Yamanouchi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Surgery
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL	095-819-7316
Homepage URL
Email	ymanouch@gk9.so-net.ne.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Center, Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki
Tel	095-819-7726
Email	ymanouch

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	2016 Year 10 Month 01 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	0
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	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Date of IRB	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 06 Month 28 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 28 Day
Last modified on	2019 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027875

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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