UMIN-CTR Clinical Trial

Public title

Differential diagnosis of colorectal neoplastic and non-neoplastic lesions with real-time numerical color analysis using autofluorescence endoscopy

Acronym

Differential diagnosis of colorectal lesions by autofluorescence endoscopy

Scientific Title

Differential diagnosis of colorectal neoplastic and non-neoplastic lesions with real-time numerical color analysis using autofluorescence endoscopy

Scientific Title:Acronym

Differential diagnosis of colorectal lesions by autofluorescence endoscopy

Region

Japan

Condition

Colorectal tumor

Classification by specialty

Medicine in general	Gastroenterology	Surgery in general
Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The present prospective study was conducted to validate the cut-off value of AF index in the differential diagnosis between colorectal neoplastic and non-neoplastic lesions.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Diagnostic yields of the cut-off value for AF index in the differential diagnosis between colorectal neoplastic and non-neoplastic lesions

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

From November 2010 to August 2012
Following the detection of colorectal lesions in WL observation, the lesions were diagnosed for neoplastic or non-neoplastic.

Interventions/Control_2

In autofluorescence mode, color-tone sampling is performed on the area that had no halation or no bleeding points which might hamper analysis by the other endoscopist who did not know details of the lesion. Surrounding normal colonic mucosa was also analyzed for its color-tone in order to compare both G/R ratios. Lesions with G/R of < 1.01 are judged to be neoplastic and that with G/R of > 1.01 are considered to be non-neoplastic. Consecutively, all lesions analyzed in the present study are endoscopically removed or biopsied and the specimens are submitted to pathologic evaluation.
Finally, pre-removal diagnoses and final pathological diagnoses are compared to each other in order to calculate the diagnostic yield of G/R ratio in the differential diagnosis of colorectal neoplastic lesions from non-neoplastic lesions.

Pathologic diagnosis
Histopathologic examination of the endoscopically or surgically resected specimen was performed on hematoxylin and eosin-stained sections, with reference to Japanese classification of colorectal carcinoma4. Lesions were classified into 2 categories based on the final pathological diagnoses, neoplastic lesions and non-neoplastic lesions. Neoplastic lesions included 5 pathological types, submucosal invasive cancer, intramucosal cancer, tubular or villous adenoma, traditional serrated adenoma (TSA) and sessile serrated adenoma (SSA). Non-neoplastic lesion included only hyperplastic lesion.

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

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

Consecutive patients who were scheduled for screening colonoscopy or endoscopic removal of colorectal lesions in our department

Key exclusion criteria

# Patients without written informed consent
# Patients who have bleeding tendency and can't undergo biopsy or endoscopic resection.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Aihara

Organization

Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

3-19-18, Nishi-shimbashi, Minato, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

Address

TEL

Homepage URL

Email

Institute

Jikei University School of Medicine

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

03

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Open public recruiting

Date of protocol fixation

2010

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

03

Month

19

Day

Last modified on

2012

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008893