UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032677 |
|---|---|
| Receipt number | R000037021 |
| Scientific Title | Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2024/11/25 10:10:35 |
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Basic information
Public title
Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Acronym
Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Scientific Title
Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Scientific Title:Acronym
Methylene Blue-Assisted Lymph Node Dissection in Colon Cancer Specimens
Region
| Japan |
Condition
Condition
Colon Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of methylene blue-assisted lymph node technique for LN assessment in colon cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
the number of harvested lymph nodes
Key secondary outcomes
the ratio of the number of the harvested lymph nodes per time(minute)
the ratio of the cases with over 12 harvested lymph nodes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Aged over 20 years old at registration.
(2)Histologically proven adenocarcinoma of the colon and clinical stage 1-3 according to Japanese Classification of Colorectal Carcinoma, the 8th edition.
(3)Colectomy with D2 or D3 lymphadenectomy.
(4)Provided written informed consent.
Key exclusion criteria
(1)Transverse colectomy.
(2)R2 resection.
(3)Clinical stgae 4 disease.
(4)Malignant colon obstruction or abscess.
(5)Preoperative chemotherapy or radiotherapy.
(6)Inappropriate for this study by the doctor's decision.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Rino |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2645
rino@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Sawazaki |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2645
Homepage URL
sho-sawady18@hotmail.co.jp
Sponsor or person
Institute
Yokohama City University, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University, Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Center for Novel and Exploratory Clinical Trials
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-370-7629
nextjim1@yokohama-cu.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
横浜市立大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.micenavi.jp/jss121/search/detail_program/id:2157
Publication of results
Published
Result
URL related to results and publications
https://www.micenavi.jp/jss121/search/detail_program/id:2157
Number of participants that the trial has enrolled
35
Results
The number of lymph nodes retrieved was 22 (10-36) in the standard group and 28 (12-56) in the stained group, with a tendency for more lymph nodes to be retrieved in the stained group (P=0.123). 1.90 (0.38-4.73) and 1.86 (0.59-3.04) nodes per minute were retrieved in the standard group and stained group, respectively, without significant difference (P=0.889). The percentages of 12 or more lymph nodes removed were 94.1% (16 cases) and 100% (18 cases), respectively, with no difference (P=0.977).
Results date posted
| 2024 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There was no difference in age, gender, preoperative ESD, preoperative tattooing, tumor localization, surgical technique, approach, lymph node dissection, operative time, or blood loss between the standard and stained groups, with a trend toward higher BMI in the standard group (P = 0.061).
Participant flow
Stratified randomization method of allocation
Allocation Adjustment Factors
Tumor localization: right-sided colon/left-sided colon
Right side: cecum to right sided transverse colon
Left side: left transverse colon to sigmoid colon
Degree of lymph node dissection: D2/D3
Adverse events
none
Outcome measures
Primary endpoint: number of lymph nodes removed
Secondary endpoints: number of lymph nodes removed/preoperative time (minutes), percentage of patients with 12 or more nodes removed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 25 | Day |
Other
Other related information
If the methylene blue assisted technique is superior to the standard approach using the fresh sample in harvesting LNs by surgeons after colectomy for colon cancer, the results contribute to prevention of stage migration and the standardization of therapy for colon cancer, not influenced by the size of the medical facility, the number of doctors and the experienced of harvesting LNs.
Management information
Registered date
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037021
