UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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.

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hideyuki Miyachi
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
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	Hideyuki Miyachi
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
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
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000013987