UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Title of the study (Brief title)	Postoperative stricture after endoscopic submucosal dissection for large colorectal tumors
Region	Japan

Condition
Condition	Mucosal and submucosal colorectal neoplasm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the risk factor of posoperative stricture after endoscopic submucosal dissection in the colorectum
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Postoperative stricure was diagnosed when a standard 11.5mm diameter colonoscope could not be negotiated through the colonic segment at the site of ESD. Follow-up endoscopy was performed 4 to 6 months later. If patients had any different clinical symptoms from those prior to the ESD, endoscopy was performed in order to check for post-ESD stenosis. All cases were divided into two groups, that is, presence or absence of postoperative stricture. The two groups were compared in respect of the patient age, gender, concomitant disease that might affect ESD ulcer healing, the tumor location, macroscopic type, longitudinal and circumferential diameter of the resected specimens, circumferential extent of the mucosal defect, and depth of invasion.The risk factor of postoperative stricure is clarified
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All cases that colorectal neoplasm is resected by endoscopic submucosal dissection
Key exclusion criteria	The case that colorectal neoplasm can not be resected by endoscopic submucosal dissection
Target sample size	700

Research contact person
Name of lead principal investigator	TAKEMASA HAYASHI
Organization	Showa University Northern Yokohama Hospital
Division name	Digective Disease Center
Address	35-1 Chigasaki-chuo Tsuzuki Yokohama Kanagawa
TEL	045-949-7717
Email	take09043946487@yahoo.co.jp

Public contact
Name of contact person	TAKEMASA HAYASHI
Organization	Showa University Northern Yokohama Hospital
Division name	Digective Disease Center
Address	35-1 Chigasaki-chuo Tsuzuki Yokohama Kanagawa
TEL	045-949-7717
Homepage URL
Email	take09043946487@yahoo.co.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital, Digestive Disease center
Institute
Department

Funding Source
Organization	non
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	2015 Year 05 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 01 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	case control study retrospective study

Management information
Registered date	2014 Year 11 Month 26 Day
Last modified on	2016 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017706