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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012079
Receipt No. R000013860
Scientific Title Assessment of safety after endoscopic submucosal desission in patients taking aspirin or other antithrombotic agents
Date of disclosure of the study information 2013/10/20
Last modified on 2020/07/21

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Basic information
Public title Assessment of safety after endoscopic submucosal desission in patients taking aspirin or other antithrombotic agents
Acronym Assessment of safety after endoscopic submucosal desission in patients taking aspirin or other antithrombotic agents
Scientific Title Assessment of safety after endoscopic submucosal desission in patients taking aspirin or other antithrombotic agents
Scientific Title:Acronym Assessment of safety after endoscopic submucosal desission in patients taking aspirin or other antithrombotic agents
Region
Japan

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

Objectives
Narrative objectives1 assessment of safety of endoscopic submucosal dissection for patiants taking aspirin or antithrombotic agents
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the probability of rebleeding
Key secondary outcomes the risk factor of bleeding

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
Medicine Maneuver
Interventions/Control_1 We perform endoscopic submucosal dissection for pationts who take some form of antithrombotic drug.
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 -Patients on some form of antithrombotic therapy who underwent ESD of gastric tumor.

-Patients from whom concents has been obtained to participate in this study, which has been approved by the ethics committee

-Other patients who are unfit for the study as determined by the attending physician
Key exclusion criteria Patients from whom concents has not been obtained to participate in this study, which has been approved by the ethics committee
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Takenaka
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code 708-0841
Address 1756 Kawasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Email daicawai@yahoo.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Kawai
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code 708-0841
Address 1756 Kwasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Homepage URL
Email daicawai@yahoo.co.jp

Sponsor
Institute Tsuyama Chuo 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 Tsuyama Chuo Hospital
Address 1756, Kawasaki, Tsuyama City
Tel 0878-21-8111
Email daicawai@yahoo.co.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 津山中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 20 Day

Related information
URL releasing protocol A prospective observational study on gastric endoscopic submucosal dissection under continuous admin
Publication of results Unpublished

Result
URL related to results and publications ESD under continuous administration of antithrombotic agents is feasible.
Number of participants that the trial has enrolled 88
Results En bloc resection was achieved in all
patients with a complete resection rate of
97.0%.
Postoperative bleeding occurred in 9
patients (10.2%). Thienopyridine derivatives was identified as independent risk factor
for postoperative bleeding.
Results date posted
2020 Year 06 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Patients underwent gastric ESD under continuous administration of antithrombotic agents.
Participant flow The clinical and pathological factors associated with postoperative bleeding in patients receiving antithrombotic agents were analyzed.
Adverse events Postoperative bleeding occurred in 9 patients(10.2%) who received antithrombotic drugs.
There was no occurrence of perforation during ESD
Outcome measures Rate of post-operative bledding
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
2013 Year 02 Month 06 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 20 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013860

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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