UMIN-CTR Clinical Trial

Public title

The study of the effect of additional chromoendoscopy in the cases which are classified into low confidence in JNET classification

Acronym

The study of the effect of additional chromoendoscopy in the LC cases of JNET classification

Scientific Title

The study of the effect of additional chromoendoscopy in the cases which are classified into low confidence in JNET classification

Scientific Title:Acronym

The study of the effect of additional chromoendoscopy in the LC cases of JNET classification

Region

Japan

Condition

colon polys

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To reveal the significance of additional chromoendoscopy in the cases which are classified into low confidence in JNET classification

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The diagnostic performance of additional chromoendoscopy in JNET low confidence cases in distinguishing between neoplastic and non-neoplastic polyps

Key secondary outcomes

1.The accuracy of additional chromoendoscopy in JNET low confidence cases
2.The accuracy of additional chromoendoscopy in JNET type2B high confidence cases
3.The proportion of cases which need additional chromoendoscopy

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients who undergo a total colonoscopy with NBI magnification

Key exclusion criteria

1.patients with a history of inflammatory bowel disease, hereditary polyposis syndrome, or Lynch syndrome
2.patients with poor bowel preparation
3.patients without polyps
4.patients whose polyp's histopathology had not been evaluated (including resect and discard cases)

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Sano Yasushi

Organization

Sano Hospital

Division name

Gastrointestinal Center

Zip code

Address

2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo

TEL

81-78-785-1000

Email

ys_endoscopy@hotmail.com

Name of contact person

1st name
Middle name
Last name	Utsumi Takahiro

Organization

Sano Hospital

Division name

Gastrointestinal Center

Zip code

Address

2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo

TEL

81-78-785-1000

Homepage URL

Email

barce10_ronald@yahoo.co.jp

Institute

Gastrointestinal Center, Sano 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

2016

Year

07

Month

13

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

There were few JNET Type 2B or Type 3 with LC cases. Therefore, in 50 patients, we analyzed 53 polyps classified as JNET Type 1 or 2A with LC prediction. The accuracy and negative predictive value of magnifying NBI (first phase) were 58.5% (95%CI, 44.1% - 71.9%) and 66.0% (95%CI, 36.6% - 77.9%), and those of magnifying chromoendoscopy (second phase) were 66.0% (95%CI, 51.7% - 78.5%) and 61.1% (95%CI, 43.5% - 76.9%), respectively.
Regardless of the findings of additional chromoendoscopy, all polyps should be resected and submitted for histopathological examination when the confidence level in differentiating adenomatous from hyperplastic polyps is low by magnifying NBI.

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

2016

Year

07

Month

11

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective study. Consecutive adult patients who underwent a colonoscopy with magnification in Sano hospital were recruited. The diagnosis of each polyp was evaluated with JNET classification and a level of confidence was described.
If the lesions were type 2B or any types with low confidence, additional chromoendoscopy (indigo carmine or crystal violet) was performed. We analysed the accuracy of additional chromoendoscopy in such cases and the proportion of cases which need additional chromoendoscopy.

Registered date

2016

Year

07

Month

12

Day

Last modified on

2018

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026562