UMIN-CTR Clinical Trial

Basic information
Public title	Is there the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma?
Acronym	Is there the need for 2nd. look endoscopy after gastric ESD?
Scientific Title	Is there the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma?
Scientific Title:Acronym	Is there the need for 2nd. look endoscopy after gastric ESD?
Region	Japan

Condition
Condition	Gastric adenoma, Early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of post procedural bleeding after gastric ESD (analysis with historical control group with 2nd. look endoscopy)
Key secondary outcomes	The rate of post procedural bleeding after gastric ESD according to tumor characteristics, another factors, and the rate of thrombosis (analysis with historical control group with 2nd. look endoscopy)

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 after gastric ESD without intraprocedural complication who have high-risk factor for post procedural bleeding
Key exclusion criteria	Patients with intraprocedural complication during gastric ESD
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Arai
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL	+81-43-226-2083
Email	araim-cib@umin.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Maruoka
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL	+81-43-226-2083
Homepage URL
Email	maruoka-cib@umin.ac.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
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	Graduate School of Medicine, Chiba University
Address	1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
Tel	+81-43-222-7171
Email	igaku-rinri@office.chiba-u.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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/epdf/10.1177/2050640618792819
Number of participants that the trial has enrolled	31
Results	After propensity score-matching,38 subjects (19 subjects in each group) were enrolled. No significant differences were observed in the rate of post-operative bleeding (POB) between the two groups (second-look-endoscopy [SLE] group, 5.3%; non-SLE group, 10.5%).
Results date posted	2022 Year 01 Month 22 Day
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	2017 Year 03 Month 26 Day
Date of IRB	2017 Year 04 Month 02 Day
Anticipated trial start date	2017 Year 04 Month 13 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To reveal the need for 2nd. look endoscopy after gastric ESD

Management information
Registered date	2017 Year 04 Month 13 Day
Last modified on	2022 Year 01 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030945