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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032677
Receipt No. R000037021
Scientific Title Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Date of disclosure of the study information 2018/06/01
Last modified on 2020/11/23

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Basic information
Public title Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Acronym Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Scientific Title Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Scientific Title:Acronym Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Region
Japan

Condition
Condition Colon Cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy of methylene blue-assisted lymph node technique for LN assessment in colon cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the number of harvested lymph nodes
Key secondary outcomes the ratio of the number of the harvested lymph nodes per time(minute)
the ratio of the cases with over 12 harvested lymph nodes

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
90 years-old >=
Gender Male and Female
Key inclusion criteria (1)Aged over 20 years old at registration.
(2)Histologically proven adenocarcinoma of the colon and clinical stage 1-3 according to Japanese Classification of Colorectal Carcinoma, the 8th edition.
(3)Colectomy with D2 or D3 lymphadenectomy.
(4)Provided written informed consent.
Key exclusion criteria (1)Transverse colectomy.
(2)R2 resection.
(3)Clinical stgae 4 disease.
(4)Malignant colon obstruction or abscess.
(5)Preoperative chemotherapy or radiotherapy.
(6)Inappropriate for this study by the doctor's decision.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Rino
Organization Yokohama City University
Division name Department of Surgery
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2645
Email rino@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Sho
Middle name
Last name Sawazaki
Organization Yokohama City University
Division name Department of Surgery
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2645
Homepage URL
Email sho-sawady18@hotmail.co.jp

Sponsor
Institute Yokohama City University, Department of Surgery
Institute
Department

Funding Source
Organization Yokohama City University, Department of Surgery
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 Yokohama City University Center for Novel and Exploratory Clinical Trials
Address 1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel 045-370-7629
Email nextjim1@yokohama-cu.ac.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 横浜市立大学

Other administrative information
Date of disclosure of the study information
2018 Year 06 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 24 Day
Date of IRB
2018 Year 04 Month 11 Day
Anticipated trial start date
2018 Year 06 Month 11 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 08 Month 31 Day
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information If the methylene blue assisted technique is superior to the standard approach using the fresh sample in harvesting LNs by surgeons after colectomy for colon cancer, the results contribute to prevention of stage migration and the standardization of therapy for colon cancer, not influenced by the size of the medical facility, the number of doctors and the experienced of harvesting LNs.

Management information
Registered date
2018 Year 05 Month 22 Day
Last modified on
2020 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037021

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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