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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028815
Receipt No. R000032984
Scientific Title Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Date of disclosure of the study information 2017/09/06
Last modified on 2019/05/23

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Basic information
Public title Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Acronym Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Scientific Title Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Scientific Title:Acronym Lymph node mapping for determination of optimum lymph node dissection for surgical treatment of colorectal cancer
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to support determination of the optimal lymph node dissection range by grasping detailed distribution status of lymph flow and metastatic lymph nodes in colorectal cancer.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of extent of lymph node metastasis (distance in axial direction of the intestinal tract, relationship with feeding vessel, central side)
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Primary colon cancer patient diagnosed histologically as adenocarcinoma.
Preoperative StageII-IV Colorectal Cancer Patient.
Key exclusion criteria Have double cancer. However, only for metachronous double cancer with a disease-free period longer than 5 years, registration is permitted.
Those with a history of operation affecting the colorectal cancer operation.
Those with a history of hypersensitivity to ICG and iodine.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryohei Sakamoto
Organization Fukuoka University School of Medicine
Division name Gastroenterological surgery
Zip code
Address 7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL 092-801-1101
Email skmt19790907@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryohei Sakamoto
Organization Fukuoka University School of Medicine
Division name Gastroenterological surgery
Zip code
Address 7 - 45 - 1 Nagakuma, Seongnam-gu, Fukuoka city, Fukuoka prefecture
TEL 092-801-1101
Homepage URL
Email skmt19790907@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Fukuoka University School of Medicine
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
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
2017 Year 09 Month 06 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
2017 Year 09 Month 06 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 09 Month 06 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032984

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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