UMIN-CTR Clinical Trial

Basic information
Public title	Examination of local recurrence after endoscopic submucosal dissection for superficial colorectal tumors
Acronym	Risk factors of local recurrence after ESD
Scientific Title	Examination of local recurrence after endoscopic submucosal dissection for superficial colorectal tumors
Scientific Title:Acronym	Risk factors of local recurrence after ESD
Region	Japan

Condition
Condition	More than 20mm superficial colorectal tumors which can be resected using endoscopy.
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate risk factors after ESD for superficial colorectal tumors.
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

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	100 years-old >=
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 in disagreement with informed consent. 2.Patients unable to follow the course after colorectal ESD
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Taishi Middle name Last name Okumura
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL	045-949-7000
Email	javier.thierry@gmail.com

Public contact
Name of contact person	1st name Taishi Middle name Last name Okumura
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL	045-949-7000
Homepage URL
Email	javier.thierry@gmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Showa University Northern Yokohama Hospital
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	Showa University Northern Yokohama Hospital
Address	35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
Tel	045-949-7175
Email	irb02syh@ofc.showa-u.ac.jp

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	2021 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1344
Results
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	2003 Year 09 Month 01 Day
Date of IRB	2021 Year 03 Month 11 Day
Anticipated trial start date	2003 Year 09 Month 01 Day
Last follow-up date	2030 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This retrospective study included 1344 patients, with a total of 1539 consecutive colorectal lesions, who underwent ESD from September 2003 to December 2019. The main outcome were incidence of local recurrence and its relationship with the clinicopathological factors in long term surveillance.

Management information
Registered date	2021 Year 09 Month 13 Day
Last modified on	2021 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049578