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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018039
Receipt No. R000020897
Scientific Title Practicality of newly improved Dual knife with water-jet function for gastrointestinal ESD
Date of disclosure of the study information 2015/06/23
Last modified on 2016/01/24

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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
Middle name
Last name Naohisa Yahagi
Organization Keio University, School of Medicine
Division name Cancer Center
Zip code
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
Middle name
Last name Tadateru Maehata
Organization Keio University, School of Medicine
Division name Cancer Center
Zip code
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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2014 Year 11 Month 06 Day
Date of IRB
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
2016 Year 01 Month 24 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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