UMIN-CTR Clinical Trial

Public title

The study of the diagnostic agreement between qualitative diagnosis by using endocytoscopy and pathological diagnosis by using biopsy in colon polyps.

Acronym

The study of the diagnostic agreement between endocytoscopy and biopsy.

Scientific Title

The study of the diagnostic agreement between qualitative diagnosis by using endocytoscopy and pathological diagnosis by using biopsy in colon polyps.

Scientific Title:Acronym

The study of the diagnostic agreement between endocytoscopy and biopsy.

Region

Japan

Condition

colon polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To reveal the diagnostic agreement between diagnosis by endocytoscopy and pathological diagnosis by biopsy in colon polyps.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The diagnostic agreement between diagnosis by endocytoscopy and pathological diagnosis by biopsy in colon polyps.

Key secondary outcomes

The proportion of cases in which the lesions are observed clearly by endocytoscopy.
Time needed in endocytoscopy.

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 endocytoscopy

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. polyps detected after three polyps was observed by endocytoscopy in a patient
5. polyps whose histopathology had not been evaluated
6. polyps which have possibility of cancer on conventional endoscopy

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Sano Yasushi

Organization

Sano Hospital

Division name

Gatrointestinal 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

Gatrointestinal Center

Zip code

Address

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

TEL

81-78-785-1000

Homepage URL

Email

barce10_ronal@yahoo.co.jp

Institute

Gatrointestinal 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

08

Month

24

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

A total of 39 patients with 63 diminutive polyps were analyzed. All polyps were evaluated by endocytoscopy. The mean polyp size was 3.3 mm. Among the 63 diminutive polyps, 60 were flat and 3 were pedunculated. The mean time required for endocytoscopic observation, including the time for staining with crystal violet and methylene blue, was 3.0 min. Histopathologic evaluation showed that 13 polyps were hyperplastic and 50 were adenomas. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of EC2 for adenoma compared with EC1b for hyperplastic polyp were 98.0%, 92.3%, 96.8%, 98.0% and 92.3%, respectively. There were only two cases of disagreement between the endoscopic diagnosis made by endocytoscopy and the corresponding histopathological diagnosis..

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

08

Month

23

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

24

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 endocytoscopy in Sano hospital were recruited. The diagnosis of each polyp more than 5mm was evaluated with EC classification was described.
If the lesions were EC1b or EC2, biopsy was performed. We analysed the diagnostic agreement between qualitative diagnosis by endocytoscopy and pathological diagnosis by biopsy.

Registered date

2016

Year

08

Month

23

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=R000027183