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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024184
Receipt No. R000027790
Scientific Title A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Date of disclosure of the study information 2016/10/01
Last modified on 2019/06/20

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Basic information
Public title A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Acronym A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Scientific Title A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Scientific Title:Acronym A pilot study of efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Region
Japan

Condition
Condition Early gastric cancer, gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy in endoscopic hand-suturing (EHS) for mucosal defects after endoscopic resection in cases with antithrombotic agents
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of postoperative bleeding within 4 weeks after endoscopic resection
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 After ESD for gastric tumors, we perform EHS for the mucosal defects. Blood examinations are performed on 1 and 3 POD, gastroendoscopy is performed on 3 POD. The patients are told to monitor whether bleeding occur within 4 weeks after discharge and we check them at outpatients clinic.
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 The antithrombotic agents users who have gastric tumors which are in indication of ESD and less than 3 cm
Key exclusion criteria The cases that tumors are located at fornix, greater curvature of upper body or lesser curvature of angle in which it is difficult to perform EHS
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Naohisa
Middle name
Last name Yahagi
Organization Keio University, School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
TEL 03-3353-1211(61591)
Email yahagi.keio@gmail.com

Public contact
Name of contact person
1st name Teppei
Middle name
Last name Akimoto
Organization Keio University, School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
TEL 03-3353-1211(61591)
Homepage URL
Email t-akimoto@nms.ac.jp

Sponsor
Institute Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University, School of Medicine
Institute
Department

Funding Source
Organization NO
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 Research Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582
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
2016 Year 10 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
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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 27 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027790

Research Plan
Registered date File name
2018/04/02 プロトコール(EHS phase II) Ver.2(2018.3).docx

Research case data specifications
Registered date File name
2018/04/02 CRF(EHS phase II) Ver.2(2017.9).docx

Research case data
Registered date File name
2018/04/02 007.pdf


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