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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023738
Receipt No. R000027183
Scientific Title The study of the diagnostic agreement between qualitative diagnosis by using endocytoscopy and pathological diagnosis by using biopsy in colon polyps.
Date of disclosure of the study information 2016/08/24
Last modified on 2018/07/17

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Basic information
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
Condition colon polyps
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Gatrointestinal Center, Sano Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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.

Management information
Registered date
2016 Year 08 Month 23 Day
Last modified on
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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