UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011974 |
|---|---|
| Receipt number | R000013987 |
| Scientific Title | The significance of the state of muscularis mucosae (MM grade) as a new risk factor for nodal metastasis in considering the indication for additional surgical colectomy with lymph node dissection among submucosal-invasive (T1) colorectal carcinomas after endoscopic treatment |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2016/04/09 11:39:09 |
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Basic information
Public title
The significance of the state of muscularis mucosae (MM grade) as a new risk factor for nodal metastasis in considering the indication for additional surgical colectomy with lymph node dissection among submucosal-invasive (T1) colorectal carcinomas after endoscopic treatment
Acronym
The significance of the state of muscularis mucosae (MM grade) as a risk factor for nodal metastasis in considering the indication for additional surgical colectomy among T1 colorectal carcinomas after endoscopic treatment
Scientific Title
The significance of the state of muscularis mucosae (MM grade) as a new risk factor for nodal metastasis in considering the indication for additional surgical colectomy with lymph node dissection among submucosal-invasive (T1) colorectal carcinomas after endoscopic treatment
Scientific Title:Acronym
The significance of the state of muscularis mucosae (MM grade) as a risk factor for nodal metastasis in considering the indication for additional surgical colectomy among T1 colorectal carcinomas after endoscopic treatment
Region
| Japan |
Condition
Condition
Colorectal carcinomas
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to confirm the significance of the state of muscularis mucosae (MM grade) as a new risk factor for nodal metastasis, to clarify pathological risk factors for lymph node metastasis of T1 colorectal cancers, and to establish the indication for additional surgical colectomy with nodal dissection after endoscopic treatment.
Basic objectives2
Others
Basic objectives -Others
Retrospective study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify pathological risk factors for lymph node metastasis of T1 colorectal cancers, confirming the significance of the state of muscularis mucosae (MM grade).
Key secondary outcomes
To establish the indication for additional surgical colectomy with lymph node dissection, based on the pathological risk factors of the excised specimen after endoscopic treatment.
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
A total of more than 20000 colorectal neoplasms excluding advanced cancers have been resected endoscopically or surgically at Showa University Northern Yokohama Hospital from 2001 to 2013. Of these, approximately 800 T1 colorectal cancers were included.
Key exclusion criteria
People not grown up
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Miyachi |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama 224-8503, Japan
TEL
045-949-7265
miyachi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Miyachi |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama 224-8503, Japan
TEL
045-949-7265
Homepage URL
miyachi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Northern Yokohama Hospital
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
Address
Tel
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
| 2013 | Year | 10 | Month | 07 | 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
Results
Results:
MM grade was associated with nodal metastasis (p = 0.026), and no patients with MM grade 1 lesions had nodal metastasis. Significant risk factors for nodal metastasis in patients with MM grade 2 lesions were attribution of female (p = 0.006), lymphovascular infiltration (p < 0.001), tumor budding (p = 0.045), and poorly differentiated adenocarcinoma or mucinous carcinoma (p = 0.007). Nodal metastasis occurred in 1.06% of lesions without any of these pathological factors, but in 10.3% and 20.1% of lesions with at least one factor in male and female patients, respectively. There was good inter-observer agreement for MM grade evaluation, with a kappa value of 0.67.
Conclusions:
Stratification using MM grade, pathological factors and patient sex provided more appropriate indication for additional surgery with lymph node dissection after endoscopic treatment for T1 colorectal carcinomas.
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background and Aim:
Recent advances in endoscopic technology have allowed many T1 colorectal carcinomas to be resected endoscopically with negative margins. However, the criteria for curative endoscopic resection remain unclear. We aimed to identify risk factors for nodal metastasis in T1 carcinoma patients and hence establish the indication for additional surgery with lymph node dissection.
Methods: Initial or additional surgery with nodal dissection was performed in 653 T1 carcinoma cases. Clinicopathological factors were retrospectively analyzed with respect to nodal metastasis. The status of the muscularis mucosae (MM grade) was defined as grade 1 (maintenance) or grade 2 (fragmentation or disappearance). The lesions were then stratified based on the risk of nodal metastasis.
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2016 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013987
