UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012079 |
|---|---|
| Receipt number | 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 19:17:41 |
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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
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
daicawai@yahoo.co.jp
Sponsor or person
Institute
Tsuyama Chuo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013860
