UMIN-CTR Clinical Trial

Basic information
Public title	Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Acronym	Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Scientific Title	Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Scientific Title:Acronym	Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Region	Japan

Condition
Condition	early gastric cancer, early colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of the Dual knife with a water-jet function for the gastrointestinal ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome is to verify the feasibility of mucosal elevation.
Key secondary outcomes	The secondary outcomes include the procedure time, the en bloc resection rate, the number of endoscopic device changes (endoscopic injection needle, different device), the adverse event rate such as post-operative bleeding and perforation.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We undergo the ESD by the use of the Dual knife with a water-jet function.
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	1)Patients who are diagnosed as early gastric cancer and early colorectal cancer and are considered as the indication of ESD treatment. 2)Provided with written informed conscent.
Key exclusion criteria	1)Patients whose lesions are found to be outside the guideline or expanded criteria for ESD. 2)Severe fibrosis. 3)Patients with hematological abnormality. 4)Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. 5)Patients who are pregnant or lactation. 6)Patients without written informed consent. 7)Lesions which are thought to be difficult to resect by ESD because of unstable positioning of endoscope. 8)Patients who are disqualified for the study by physicians 9)Refusal of the trial entry.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naohisa Middle name Last name Yahagi
Organization	Keio University, School of Medicine
Division name	Cancer Center
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	yahagi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Tadateru Middle name Last name Maehata
Organization	Keio University, School of Medicine
Division name	Cancer Center
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	t2maehata@marianna-u.ac.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Keio University, School of Medicine
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	Keio University
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	2015 Year 06 Month 23 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
Results	All the lesions were successfully treated by mucosal elevation. The median resected specimen size in stomach and colorectum lesions were 37.3mm and 34.0 mm respectively. The mean procedure time in stomach and colorectum lesions were 36 min and 32.3 min respectively. The en bloc resection rates were 100% in both lesions. The median number of endoscopic device changes in stomach and colorectum lesions were three times and four times respectively. No severe adverse events were observed in both lesions.
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	2014 Year 11 Month 06 Day
Date of IRB	2014 Year 11 Month 19 Day
Anticipated trial start date	2014 Year 11 Month 19 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 23 Day
Last modified on	2021 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020897