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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name