UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of the precut coagulation at super-low output discharging set
Title of the study (Brief title)	Effectiveness of the precut coagulation at super-low output discharging set
Region	Japan

Condition
Condition	superficial gastric tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluating effectiveness of precut coagulation by Flush knife BT at super-low output discharge set
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the frequency of intraoperative hemostasis requiring hemostatic forceps
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	precut coagulation by hemostatic forceps
Interventions/Control_2	precut coagulation by Flush knife BT at super-low output discharge set
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	expanded criteria for gastric ESD
Key exclusion criteria	Patients who 1) under antithrombotic therapy 2) have recurrence lesion 3) past radiation 4) have pregnancy 5) have infectious diseases 6) have allergy to drugs for intervention
Target sample size	60

Research contact person
Name of lead principal investigator	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Email	horikawa_01@me.com

Public contact
Name of contact person	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Homepage URL
Email	horikawa_01@me.com

Sponsor
Institute	Hiraka General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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 04 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 20 Day
Anticipated trial start date	2015 Year 04 Month 21 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

Management information
Registered date	2015 Year 04 Month 21 Day
Last modified on	2016 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019982