UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Title of the study (Brief title)	Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and efficacy of Hook knife with water jet function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The insertion number of injection needle per resected area.
Key secondary outcomes	Procedure duration of ESD per resected area (from injection to the end of dissection) The number and amount of the injection from mucosa by injection needle per resected area The number and amount of the injection to submucosal layer by injection needle per resected area The number and amount of the injection from mucosa by Hook knife with water jet function per resected area The number and amount of the injection to submucosal layer by Hook knife with water jet function per resected area

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hook Knife
Interventions/Control_2	Hook Knife with Water Jet Function
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	1) Gastric or esophageal cancer which has indication of endoscopic submucosal dissection. 2) Written and signed consent for trial participation must be obtained from the patient.
Key exclusion criteria	1) Prior radiotherapy from mediastinum to upper abdomen. 2) The subject judged as without eligibility for the safety of this study by lead principal investigator or contact doctor.
Target sample size	40

Research contact person
Name of lead principal investigator	Tsuneo Oyama
Organization	Saku Central Hospital Advanced Care Center
Division name	Department of Endoscopy
Address	3400-28 Nakagomi, Saku, JAPAN
TEL	0267-62-8181
Email	oyama@coral.ocn.ne.jp

Public contact
Name of contact person	Akiko Takahashi
Organization	Saku Central Hospital Advanced Care Center
Division name	Department of Endoscopy
Address	3400-28 Nakagomi, Saku, JAPAN
TEL	0267-62-8181
Homepage URL
Email	ctroffice@sakuhp.or.jp

Sponsor
Institute	Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization	Saku Central Hospital Advanced Care Center
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	佐久総合病院佐久医療センター（長野県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 11 Month 28 Day
Date analysis concluded	2016 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 08 Day
Last modified on	2017 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019769