UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography to predict deep submucosal invasion in scheduled ESD patients
Title of the study (Brief title)	Comparison of NBI, chromoendoscopy, and endoscopic ultrasonography to predict deep submucosal invasion in scheduled ESD patients
Region	Asia(except Japan)

Condition
Condition	Colorectal ESD
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary end point was accuracy for prediction of depth of invasion and histology.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the accuracy for the prediction of depth of invasion and histology of superficial colorectal tumor before C-ESD
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with superficial colorectal tumor detected during previous colonoscopy
Key exclusion criteria	morphologically advanced colorectal cancer,coexistence of advanced cancer,previously diagnosed with familial adenomatous polyposis, ulcerative colitis, and crohn's disease,coagulation abnormality
Target sample size	50

Research contact person
Name of lead principal investigator	Bong Min Ko
Organization	SoonChunHyang University School of Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon
Division name	Department of Internal Medicine
Address	SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL	+82-32-621-5094
Email	kopa9445@schmc.ac.kr

Public contact
Name of contact person	Hyeon Jeong Goong
Organization	SoonChunHyang University School of Medicine
Division name	Department of Internal Medicine
Address	SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL	+82-32-621-5094
Homepage URL
Email	goong@schmc.ac.kr

Sponsor
Institute	SoonChunHyang University Bucheon Hospital
Institute
Department

Funding Source
Organization	No funding source
Organization
Division
Category of Funding Organization	Non profit foundation
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	2017 Year 03 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 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	Unpublished
URL releasing results
Results
Other related information	We evaluated colorectal tumors by chromoencoscopy, NBI, and EUS before colorectal ESD

Management information
Registered date	2017 Year 03 Month 01 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030268