UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023892 |
|---|---|
| Receipt number | 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 16:56:22 |
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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
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
hmaeda@kochi-u.ac.jp
Sponsor or person
Institute
Cancer Treatment Center, Kochi Medical School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027444
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