UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short and long term outcomes of the endoscopic submucosal dissection for the colorectal tumors: single center, large, cohort study
Title of the study (Brief title)	Outcomes of colorectal ESDs.
Region	Japan

Condition
Condition	Colorectal neoplasms
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the short and long term outcomes and risk factors for the complications and difficulty of ESD completion among patients received ESD for the colorectal neoplasms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	En-block R0 resection rate, curative resection rate, complication rate(perforation, postoperative bleeding)
Key secondary outcomes	tumor diameter, resected specimen diameter, macroscopic type, location, pathological characteristics, procedure time, dissection speed

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	20mm or more colorectal adenoma, intramucosal or slightly-invaded submucosal colorectal neoplasms were considered eligible.
Key exclusion criteria	1.Patients whose lesions were found to be outside the guideline or expanded criteria for ESD by the endoscopic characteristics and histological findings of biopsy specimens. 2.Patients in disagreement with informed consent.
Target sample size	1000

Research contact person
Name of lead principal investigator	Tomoaki Tashima
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL	+81-3-3448-6547
Email	t.tashima1981@gmail.com

Public contact
Name of contact person	Tomoaki Tashima
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL	+81-3-3448-6547
Homepage URL
Email	t.tashima1981@gmail.com

Sponsor
Institute	Tomoaki Tashima
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 02 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 09 Day
Anticipated trial start date	2016 Year 02 Month 15 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	prospective cohort study From April 2007,patients were treated by endoscopic submucosal dissection at NTT Medical Center Tokyo.

Management information
Registered date	2016 Year 02 Month 14 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024260