UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the diagnostic agreement between qualitative diagnosis by using endocytoscopy and pathological diagnosis by using biopsy in colon polyps.
Title of the study (Brief title)	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	Sano Yasushi
Organization	Sano Hospital
Division name	Gatrointestinal Center
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	Utsumi Takahiro
Organization	Sano Hospital
Division name	Gatrointestinal Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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..
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