UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053338 |
|---|---|
| Receipt number | R000060881 |
| Scientific Title | Development of fat removal technology to optimize lymph node retrieval after surgery |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/12 19:04:08 |
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Basic information
Public title
Development of fat removal technology to optimize lymph node retrieval after surgery
Acronym
Optimization of lymph node retrieval after surgery
Scientific Title
Development of fat removal technology to optimize lymph node retrieval after surgery
Scientific Title:Acronym
Optimization of lymph node retrieval after surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Information regarding lymph node metastasis of malignant disease is important for accurate staging and treatment decisions. In Japan, the surgeons manually search for lymph nodes in the fat of resected specimen after surgery. Identification of lymph node depends on the judgment of each surgeon, so subjectivity and technical differences are unavoidable. It has been reported that there are large differences in the number of lymph nodes retrieved by each sergeon. In addition, the processing requires a lot of effort and time from the surgeon. Optimization of the lymph node retrieval can simplify the surgeon's work, and is expected to improve the chances of oversight and accidental exposure to infected tissue. The purpose of this research is to establish an efficient lymph node retrieval technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue weight change after fat removal processing
Key secondary outcomes
Pathological evaluation of lymph node degeneration
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
1. Patients who underwent colorectal cancer surgery at Tsukuba Gastrointestinal Hospital
2. Patients who consented using the "Consent Form Regarding Storage and Use of Surplus Specimens"
Key exclusion criteria
Patients judged ineligible by the research director
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigehiro |
| Middle name | |
| Last name | Kojima |
Organization
Tsukuba Gastrointestinal Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
300-1252
Address
1-2-39 Takamihara, Tsukuba, Ibaraki, Japan
TEL
029-874-3321
oshige113gou1212@gmail.com
Public contact
Name of contact person
| 1st name | Shigehiro |
| Middle name | |
| Last name | Kojima |
Organization
Tsukuba Gastrointestinal Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
300-1252
Address
1-2-39 Takamihara, Tsukuba, Ibaraki, Japan
TEL
029-874-3321
Homepage URL
oshige113gou1212@gmail.com
Sponsor or person
Institute
Tsukuba Gastrointestinal Hospital
Institute
Department
Personal name
Shigehiro Kojima
Funding Source
Organization
TERUMO LIFE SCIENCE FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Gastrointestinal Hospital
Address
1-2-39 Takamihara, Tsukuba, Ibaraki, Japan
Tel
029-874-3321
s.kojima@tsukubaichou.com
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
筑波胃腸病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 15 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a proof of concept study using surplus samples.
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060881
