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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026051
Receipt No. R000029937
Scientific Title Efficacy of polyglycolic acid sheets and fibrin glue for patients with continuous low-dose aspirin
Date of disclosure of the study information 2017/02/27
Last modified on 2018/08/30

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Basic information
Public title Efficacy of polyglycolic acid sheets and fibrin glue for patients with continuous low-dose aspirin
Acronym PGA sheets for gastric ESD with continuous LDA
Scientific Title Efficacy of polyglycolic acid sheets and fibrin glue for patients with continuous low-dose aspirin
Scientific Title:Acronym PGA sheets for gastric ESD with continuous LDA
Region
Japan

Condition
Condition The indicated lesion for gastric ESD with continuous use of aspirin
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy and safety of PGA sheets for gastric ESD with continuous aspirin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of postoperative bleeding after gastric ESD.
Key secondary outcomes Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sealing with polyglycolic acid sheets and fibrin glue for a mucosal defect following gastric ESD.
Interventions/Control_2 Without PGA sheets.
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 Patients who had a superficial gastric neoplasms(adenoma or adenocarcinoma) by preoperative estimation which were scheduled to undergo gastric ESD.
Key exclusion criteria Patients who have hematological abnormality and/or undergoing hemodialysis
Patients who have serious complications
Patients who are considered to be inappropriate for this study by doctors
Patients who have polypoid lesions and/or inflammatory bowel disease
Women who have baby and are pregnant
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Harada
Organization New Tokyo Hospital
Division name Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL 047-711-8700
Email nerimaendo@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Harada
Organization New Tokyo Hospital
Division name Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL 047-711-8700
Homepage URL
Email nerimaendo@hotmail.co.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

Funding Source
Organization New Tokyo Hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 02 Month 27 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 Terminated
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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
2017 Year 02 Month 08 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029937

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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