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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013995
Receipt No. R000016306
Scientific Title The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy. -multicenter randomized control study-
Date of disclosure of the study information 2014/06/01
Last modified on 2016/07/05

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Basic information
Public title The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy.
-multicenter randomized control study-
Acronym The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy.
-multicenter randomized control study-
Scientific Title The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy.
-multicenter randomized control study-
Scientific Title:Acronym The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy.
-multicenter randomized control study-
Region
Japan

Condition
Condition gastric neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine safety of ESD and efficacy of endoscopic tissue shielding method with PGA sheets and fibrin glue for the prevention of post-ESD bleeding in patients taking antiplatelet agents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dalayed bleeding
Key secondary outcomes ・intraoperative bleeding
・en bloc resection rate
・resection with a tumor-free margin rate
・curative resection rate
・remaining period and remaining rate of PGA sheets
・incidence of perioperative thromboembolic event

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Covering mucosal defects after ESD with PGA sheets and fibrin glue.
Interventions/Control_2 Do not covering mucosal defects after ESD with PGA sheets and fibrin glue.
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) The patients on antiplatelet therapy who will undergo ESD of gastric neoplasms.
2) Early gastric cancer based on its absolute indication and extended indication criteria.

3) There is no significant metastasis clinically.
4) The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.
5) In principle, the antiplatelet agent is low dose aspirin(LDA) only. In the case of the patients who are received multidrug therapy, they are displaceable to LDA only.
Key exclusion criteria 1)Patient who have double cancer
(The cancer in situ or intramucosal carcinoma which can be cured completely by endoscopy operation, that is proper.)
2)Patient with the following serious complications
・severe hepatic dysorder
・severe heart disease(myocardial infarction,angina,congestive heart failure)
・severe renal dysfunction
3)The patient who have severe infection
4)Pregnant woman or with the possibility.The woman who is lactation period.
5)Severe bleeding or shock state.
6)Patients with bleeding tendency.
7)Patients who have not passed more than three months after the end or are participating in the another clinical study.
8)Those who are considered to be inappropriate for this study by doctors.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakao
Organization Nagasaki University Hospital
Division name Department of Gastroenterology and hepatology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7482
Email kazuhiko@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noyuki Yamaguchi
Organization Nagasaki University Hospital
Division name Department of GASTROENTEROLOGY and HEPATOLOGY,
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7481
Homepage URL
Email naoyuki3334@hotmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization none
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 長崎医療センター
佐世保共済病院
戸畑共立病院
大分大学病院
福岡大学筑紫病院
九州医療センター
佐賀県立医療センター好生館
済生会熊本病院
鹿児島大学病院
宮崎大学病院
嬉野医療センター
鳥取大学医学部附属病院
鳥取県立中央病院
鳥取赤十字病院

Other administrative information
Date of disclosure of the study information
2014 Year 06 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
2014 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 28 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
2014 Year 05 Month 19 Day
Last modified on
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016306

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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