UMIN-CTR Clinical Trial

Public title

Chromoendoscopy using the non-extension sign as a marker is comparable to endoscopic ultrasonography in terms of diagnostic performance for evaluating the invasion depth of early colorectal cancer

Acronym

Endoscopic evaluation for invasion depth of early colorectal cancer

Scientific Title

Chromoendoscopy using the non-extension sign as a marker is comparable to endoscopic ultrasonography in terms of diagnostic performance for evaluating the invasion depth of early colorectal cancer

Scientific Title:Acronym

Chromoendoscopy using the non-extension sign as a marker is comparable to endoscopic ultrasonography in terms of diagnostic performance for evaluating the invasion depth of early colorectal cancer

Region

Japan

Condition

early colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare chromoendoscopy (CE) using the non-extension sign (NES) as a marker with EUS in evaluating invasion depth of T1b.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare diagnostic performance (sensitivity, specificity, and accuracy) for evaluating the invasion depth of T1b cancer between CE using the NES as a marker and EUS.

Key secondary outcomes

To determine the additive effect of EUS for correctly diagnosing patients in whom the invasion depth of T1b cancer was misdiagnosed by CE, to compare the diagnostic performance (sensitivity, specificity, and accuracy) of CE and magnifying endoscopy (M-NBI and M-CE) in evaluating the invasion depth of T1b cancer, and to determine the additive effect of magnifying endoscopy (M-NBI and M-CE) for correctly diagnosing patients in whom the invasion depth of T1b cancer was misdiagnosed by CE.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) patients with early colorectal cancer who underwent endoscopic or surgical resection at Fukuoka University Chikushi Hospital between January 2010 and April 2020 whose resected specimens were available for detailed histopathological examination and (2) patients in whom the modalities of CE using the NES as a marker, M-NBI, M-CE using crystal violet staining, and EUS were performed for diagnosing invasion depth during preoperative examination.

Key exclusion criteria

(1) patients in whom any of the modalities was difficult to perform and (2) patients whose lesions were difficult to visualize by EUS.

Target sample size

45

Name of lead principal investigator

1st name	Kenshi
Middle name
Last name	Yao

Organization

Fukuoka University Chikushi Hospital

Division name

Endoscopy

Zip code

818-0067

Address

1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture

TEL

092-921-1011

Email

yao@fukuoka-u.ac.jp

Name of contact person

1st name	Kazuhiro
Middle name
Last name	Takeda

Organization

Fukuoka University Chikushi Hospital

Division name

Endoscopy

Zip code

818-0067

Address

1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture

TEL

092-921-1011

Homepage URL

Email

newzealand_greg@yahoo.co.jp

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name

Organization

Fukuoka University Chikushi Hospital Endoscopy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka university medical ethics committee

Address

7-45-1 Nanakuma, Jonanku, Fukuoka city, Fukuoka prefecture

Tel

092-801-1011

Email

chikushirinsho@adm.Fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学筑紫病院（福岡県）

Date of disclosure of the study information

2023

Year

07

Month

13

Day

URL releasing protocol

https://fukuoka-u.repo.nii.ac.jp/records/2000168

Publication of results

Published

URL related to results and publications

https://fukuoka-u.repo.nii.ac.jp/records/2000168

Number of participants that the trial has enrolled

45

Results

CE had a accuracy of 75.6%, sensitivity of 78.1%, and specificity of 69.2% for T1b cancer invasion depth, while the corresponding figures were 71.1%, 78.1%, and 53.9% for EUS. Thus, CE showed comparable sensitivity to EUS but had higher specificity and accuracy without significant differences.

Results date posted

2025

Year

01

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study selected and analyzed patients with early colorectal cancer who met the following inclusion and exclusion criteria. The inclusion criteria were as follows: (1) patients with early colorectal cancer who underwent endoscopic or surgical resection at Fukuoka University Chikushi Hospital between January 2010 and April 2020 whose resected specimens were available for detailed histopathological examination and (2) patients in whom the modalities of CE using the NES as a marker, M-NBI, M-CE using crystal violet staining, and EUS were performed for diagnosing invasion depth during preoperative examination. The exclusion criteria were as follows: (1) patients in whom any of the modalities was difficult to perform and (2) patients whose lesions were difficult to visualize by EUS.

Participant flow

Endoscopy procedures
A total colonoscopy was performed first. When the targeted lesions were suspected of early colorectal cancer, the following modalities were utilized to diagnose invasion depth. CE using the NES as a marker, followed by M-NBI, and then M-CE using crystal violet staining. When these modalities led to a suspicion of T1b cancer, EUS was performed for suspicious lesions.

Adverse events

None.

Outcome measures

The primary endpoint was to compare diagnostic performance (sensitivity, specificity, and accuracy) for evaluating the invasion depth of T1b cancer between CE using the NES as a marker and EUS. The secondary endpoints were to determine the additive effect of EUS for correctly diagnosing patients in whom the invasion depth of T1b cancer was misdiagnosed by CE, to compare the diagnostic performance (sensitivity, specificity, and accuracy) of CE and magnifying endoscopy (M-NBI and M-CE) in evaluating the invasion depth of T1b cancer, and to determine the additive effect of magnifying endoscopy (M-NBI and M-CE) for correctly diagnosing patients in whom the invasion depth of T1b cancer was misdiagnosed by CE.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

09

Month

02

Day

Date of IRB

2020

Year

11

Month

09

Day

Anticipated trial start date

2020

Year

11

Month

09

Day

Last follow-up date

2023

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

No reports have compared diagnostic performance between non-extension sign (NES)-based chromoendoscopy (CE) and endoscopic ultrasonography (EUS), magnifying endoscopy with narrow-band imaging (M-NBI), or magnifying chromoendoscopy (M-CE) for invasion depth evaluation for T1b cancer.

Registered date

2023

Year

07

Month

13

Day

Last modified on

2025

Year

01

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058868