UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029448 |
|---|---|
| Receipt number | 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 | 2020/10/06 10:08:43 |
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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
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
Results
Using 37 matched patients from each group, we identified 20.6 (SD:7.2) LNs after the fat dissolution method compared to 13.5(SD:5.9) after the conventional method. Three patients among FD group received inappropriate LN examination in terms of number, while the number of the retrieved LN examination was less than 12 in 12 patients of Control group.
Results date posted
| 2020 | Year | 10 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay of acceptance
Date of the first journal publication of results
| 2020 | Year | 01 | Month | 07 | Day |
Baseline Characteristics
For fat dissolution group, 38 patients (19 female and 19 male patients) were analyzed.
Participant flow
Of the 40 patients, 2 were excluded because of peritoneal dissemination identified during the laparotomy in one case and tumor located in the lower rectum in the second case. Then, by using 4 factors with a significant impact on the number of retrieved LNs, 74 patients were extracted from each group in a 1:1 ratio
Adverse events
No
Outcome measures
The mean number of LNs identified in the FD group was 20.6(SD:7.19), compared to a mean of 13.5(SD:5.9) LNs using the conventional method (P less than 0.01; Table 2 and Figure 2), revealing the efficacy of the newly developed fat dissolution method.
Plan to share IPD
All data was provided in the manuscript
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033643
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