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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029448
Receipt No. R000033643
Scientific Title Lymph node retrieval using fat dissolution technique after surgical resection of colorectal cancer
Date of disclosure of the study information 2017/10/09
Last modified on 2019/10/02

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Basic information
Public title Lymph node retrieval using fat dissolution technique after surgical resection of colorectal cancer
Acronym Lymph node retrieval using fat dissolution technique after surgical resection of colorectal cancer
Scientific Title Lymph node retrieval using fat dissolution technique after surgical resection of colorectal cancer
Scientific Title:Acronym Lymph node retrieval using fat dissolution technique after surgical resection of colorectal cancer
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Surgery in general Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of the number of retrieved lymph nodes obtained by conventional method and that obtained by new method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the number of retrieved lymph nodes obtained by conventional method and that obtained by new method
Key secondary outcomes The difference of retrieved lymph nodes number between institutes, reporting microscopic observation of retrieved lymph nodes, stainability of metastatic tumors to tumor specific markers, the diameters of positive lymph nodes.
As explorative study, the remnant mesentery will be further incubated with fat dissolution liquid. Lymph nodes, if any, will be microscopically observed to clarify the effect of longer incubation at 40 degree.

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Application of fat dissociation method on the resected mesentery of colon and rectum.
Lymph nodes will be searched for after fat dissolution.
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 (1) A patient has diagnosis of colorectal (Rb rectal cancer is excluded) cancer via endoscopic and/or pathological examination.
(2) Distant metastasis is absent.
(3) A patient is 20 years old or older.
(4) A patient is able to fully understand the present study, and provide written informed consent.
Key exclusion criteria When the investigator consider it inappropriate to include the patient into this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kobayashi
Middle name
Last name Michiya
Organization Kochi Medical School Hospital
Division name Cancer Treatment Center
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku, Kochi, Japan, 783-8505
TEL +81-888-80-2182
Email kobayasm@kochi-u.ac.jp

Public contact
Name of contact person
1st name Maeda
Middle name
Last name Hiromichi
Organization Kochi Medical School Hospital
Division name Cancer Treatment Center
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku, Kochi, Japan, 783-8505
TEL +81-888-80-2182
Homepage URL
Email hmaeda@kochi-u.ac.jp

Sponsor
Institute Cancer Treatment Center, Kochi Medical School Hospital
Institute
Department

Funding Source
Organization Sysmex Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kochi Medical School Hospital
Address Nankoku
Tel 088-880-2226
Email rinri21@kochi-u.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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 38
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason The manuscript is not accepted yet.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
2017 Year 09 Month 29 Day
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
2018 Year 08 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033643

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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