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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023892
Receipt No. R000027444
Scientific Title The efficacy of ImofullyTM in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Date of disclosure of the study information 2016/09/01
Last modified on 2019/04/02

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Basic information
Public title The efficacy of ImofullyTM in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Acronym The efficacy of ImofullyTM in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Scientific Title The efficacy of ImofullyTM in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Scientific Title:Acronym The efficacy of ImofullyTM in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of Imofully in lymph node retrieval for pathological examination after surgical resection of colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The number of the additionally retrieved lymph nodes after fat dissolution
Key secondary outcomes 1)Rate of positive lymph node among additional lymph nodes.
2)Influence of the additional lymph nodes on the treatment decision.
3)Maximum diameter of additionally examined lymph nodes
4)Stainability of tumor specific antigens

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 Prevention
Type of intervention
Other
Interventions/Control_1 After lymph node retrieval with conventional method, lymph node retrieval was performed again after fat dissolution with Imofully
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. Planned surgical resection and lymph node dissection for colorectal cancer.
2. The age of 20 or more
3. Providing written informed consent before enrollment.
Key exclusion criteria Failing to meet the inclusion criteria.
Target sample size 20

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 7838505
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 Oko-chi Kohasu 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 高知大学医学部附属病院(高知県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/acrt/25/2/25_90/_pdf
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777345/pdf/ol-15-02-2495.pdf
Number of participants that the trial has enrolled 20
Results
The median number of LNs identified at the initial and second assessments was 13 and 6, respectively, producing a significant increase in total LNs evaluated (13 vs. 20, P<0.01, paired t-test)
Results date posted
2019 Year 04 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 20 patients participated in this study between
September 2016 and January 2017. The clinical features of
the participating patients are presented in Table I. One patient
was excluded from the analysis because LN dissection was
not performed due to an oncological reason (Table I). Of the
remaining 19 patients, 7 were male, 6 had rectal cancer, and
17 underwent laparoscopic surgery. The mean age of the patients
was 69.1 years and their mean BMI was 22.1 kg/m2
 (Table I)
Participant flow
One patient was excluded from the analysis because LN dissection was not performed due to an oncological reason 
Adverse events
none
Outcome measures
The LNs identified at the initial search was 13 (ranging from 3 - 31), while the second search identified a median of 6 additional LNs (1-13).

Plan to share IPD not planned
IPD sharing Plan description N/A

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
2016 Year 08 Month 29 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 01 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027444

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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