UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001100
Receipt number R000001333
Scientific Title Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma
Date of disclosure of the study information 2008/04/01
Last modified on 2012/03/28 16:14:08

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Basic information

Public title

Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma

Acronym

Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma

Scientific Title

Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma

Scientific Title:Acronym

Clinical reseach of video assisted neck surgery for papillary thyroid carcinoma

Region

Japan


Condition

Condition

papillary thyroid carcinoma

Classification by specialty

Endocrine surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Confirmation of the efficacy and the safety about the video assisted surgery for papillary thyroid carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The width of lymph nodes dissection

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

video assisted surgery

Interventions/Control_2

open surgery

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

15 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

papillary thyroid carcinoma

Key exclusion criteria

poorly or undifferentiated carcinoma

Target sample size

26


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisato Hara

Organization

Tsukuba Univesity Hospital

Division name

Department of Breast Thyroid Endocrine Surgery

Zip code


Address

2-1-1 Amakubo Tsukuba Ibaraki

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tsukuba University Hospital

Division name

Department of Breast Thyroid Endocrine Surgery

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Tsukuba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2008 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

There was no significant difference between the video-assisted group and the non video-assisted group in the comparison of operative time, blood loss, and range of lymph node dissection. On the other hand, the length of skin incision in the video-assisted group was significantly smaller than those in the non video-assisted group.Video-assisted thyroidectomy and modified radical neck dissection might be an acceptable procedure for the surgery of the papillary thyroid carcinoma.

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

2008 Year 03 Month 27 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2009 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 02 Month 01 Day

Date trial data considered complete

2011 Year 02 Month 01 Day

Date analysis concluded

2011 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 03 Month 27 Day

Last modified on

2012 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name