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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009331
Receipt No. R000010956
Scientific Title A study of minimally invasive surgery combined with sentinel lymph node biopsy using an indocyanine green fluorescence method and transoral resection in laryngo-pharyngeal cancer
Date of disclosure of the study information 2012/11/13
Last modified on 2019/06/25

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Basic information
Public title A study of minimally invasive surgery combined with sentinel lymph node biopsy using an indocyanine green fluorescence method and transoral resection in laryngo-pharyngeal cancer
Acronym Sentinel lymph node biopsy using an ICG fluorescence method and transoral pharyngectomy
Scientific Title A study of minimally invasive surgery combined with sentinel lymph node biopsy using an indocyanine green fluorescence method and transoral resection in laryngo-pharyngeal cancer
Scientific Title:Acronym Sentinel lymph node biopsy using an ICG fluorescence method and transoral pharyngectomy
Region
Japan

Condition
Condition Laryngo-pharyngeal cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study clarifies that the combination with sentinel lymph node biopsy using an ICG fluorescence method and transoral pharyngectomy enables an optimum and minimally invasive surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes We focus on the rate of postoperative cervical node recurrence
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Sentinel lymph node biopsy using an ICG fluorescence method and transoral pharyngectomy
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 Previously untreated and resectable transorally supraglottic, oro- and hypopharyngeal squamous cell carcinoma patients with clinically negative neck are the candidates for our study
Key exclusion criteria 1)Previously treated patients
2)A history of radiation therapy for the neck
3)Pregnancy or lactating women, or women with suspected pregnancy
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Hasegawa
Organization Aichi Cancer Center
Division name Department of Head and Neck Surgery
Zip code
Address 1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL 052-764-2944
Email hasegawa@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhisa Hasegawa
Organization Aichi Cancer Center
Division name Department of Head and Neck Surgery
Zip code
Address 1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL 052-762-6111
Homepage URL
Email hasegawa@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grant for Clinical Cancer Research (H24-Gannorinshou-Ippan-006)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1)Graduate School of Medicine Kyoto University
2)National Defense Medical College
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
2012 Year 11 Month 13 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 Completed
Date of protocol fixation
2012 Year 09 Month 20 Day
Date of IRB
2012 Year 11 Month 02 Day
Anticipated trial start date
2012 Year 11 Month 14 Day
Last follow-up date
2015 Year 11 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 13 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010956

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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