UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Acronym	Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Scientific Title	Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Scientific Title:Acronym	Usefulness of epinephrine-added injection solution for reduction of procedure time of gastric endoscopic submucosal dissection: a propensity score-matching analysis
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Epinephrine-added submucosal injection solution is used to facilitate hemostasis of non-variceal upper gastrointestinal bleeding and prevent delayed bleeding of large pedunculated colorectal lesions. However, its benefit on gastric endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is unclear and was examined here using propensity score-matching analysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The aim of this study was to clarify the benefit of the injection of epinephrine added solution into the submucosa during ESD in early gastric cancer.
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 who are indicated for gastric ESD
Key exclusion criteria	adenoma
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Noriya Middle name Last name Uedo
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code	541-8567
Address	3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL	(+81)6-(6945)-1181
Email	noriya.uedo@gmail.com

Public contact
Name of contact person	1st name Shuntaro Middle name Last name Inoue
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Zip code	541-8567
Address	3-1-69 Otemae, Chuo-ku, Osaka, Japan
TEL	06-(6945)-1181
Homepage URL
Email	inoue.shuntarou@gmail.com

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69 Otemae, Chuo-ku, Osaka, Japan
Tel	(+81) 6-(6945)-1181
Email	rinri01@opho.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	2020 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1599
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	2019 Year 01 Month 04 Day
Date of IRB	2019 Year 01 Month 04 Day
Anticipated trial start date	2019 Year 01 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2020 Year 01 Month 28 Day

Other
Other related information	In total, 1,599 patients with solitary EGCs (83 patients treated with non-epinephrine added solution: non-epinephrine group and 1,516 patients treated with epinephrine-added solution: epinephrine group) were enrolled in this study between 2011 and 2018.

Management information
Registered date	2020 Year 01 Month 30 Day
Last modified on	2020 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044848