UMIN-CTR Clinical Trial

Public title

Study of the usefulness of surface pattern observed by magnifying narrow-band imaging(NBI) in early colorectal cacner:Pilot study

Acronym

Surface pattern of early colorectal cancer

Scientific Title

Study of the usefulness of surface pattern observed by magnifying narrow-band imaging(NBI) in early colorectal cacner:Pilot study

Scientific Title:Acronym

Surface pattern of early colorectal cancer

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate if surface pattern by magnifying NBI can be used to predict invasion depth in colorectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

(1)Diagnostic specifity
(2)Diagnostic sensitivity

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Magnified endoscopy with NBI

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Early coloretal cancer(intramucosal cancer or submucosal invasive cancer)
(2)Lesions observed by magnifying NBI
(3)Over 20 years old
(4)Written informed consent

Key exclusion criteria

(1)Advanced colorectal cancer(T2 or more)
(2)Low or high grade adenoma
(3)Poor condition to obtain appropriate endoscopic images

Target sample size

350

Name of lead principal investigator

1st name
Middle name
Last name	Masashi Misawa

Organization

Showa University, Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

Address

35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan

TEL

045-949-7265

Email

Name of contact person

1st name
Middle name
Last name	Masashi Misawa

Organization

Showa University, Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

Address

35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan

TEL

Homepage URL

Email

misawaanny@ybb.ne.jp

Institute

Showa University, Northern Yokohama Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23673484

Number of participants that the trial has enrolled

Results

Narrow-band imaging (NBI) of surface microvessels of colorectal lesions is useful for differentiating neoplasms from non-neoplasms and for predicting histopathological diagnosis. Furthermore, NBI of surface microstructure, or 'surface pattern', is valuable for predicting histopathology in colorectal cancer. The aim of the present study was to investigate whether surface patterns could be used to predict invasion depth in colorectal cancer, and to compare the accuracy of surface pattern diagnosis in each macroscopic type. Between January 2010 and March 2011, a series of 357 consecutive patients with 378 early colorectal cancers were observed by magnifying NBI and the surface pattern was prospectively evaluated. Surface pattern was classified into 3 types: type I, microstructure was clearly recognised with uniform arrangement and form; type II, microstructure was obscured with heterogeneous arrangement and form; and type III, microstructure was invisible. We also classified the macroscopic type into 3 categories: depressed, protruded and flat elevated. Assuming that type III was an index of massively invasive lesions in the submucosal layer (SMm), the sensitivity, specificity and accuracy were 56.9, 91.7 and 85.7%, respectively. The sensitivity, specificity and accuracy of type III for the diagnosis of SMm in each macroscopic type were: depressed, 88.9, 40.0 and 63.2%, respectively; protruded: 34.8, 96.4 and 90.0%, respectively; and flat elevated, 54.2, 92.7 and 85.0%, respectively. These results suggest that the diagnostic accuracy of surface pattern was insufficient and particularly poor for depressed-type lesions.

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

2011

Year

03

Month

01

Day

Date of closure to data entry

2011

Year

03

Month

01

Day

Date trial data considered complete

2011

Year

03

Month

01

Day

Date analysis concluded

Other related information

This study was registered on UMIN-CTR after finished.

Registered date

2012

Year

04

Month

09

Day

Last modified on

2014

Year

08

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009063