UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016475 |
|---|---|
| Receipt number | R000019136 |
| Scientific Title | The late follow-up endoscopy as bleeding prevention after the gastric endoscopic submucosal dissection in the patient with thienopyridine derivative or low-dose aspirin and warfarin combination |
| Date of disclosure of the study information | 2015/02/08 |
| Last modified on | 2020/02/14 20:22:03 |
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Basic information
Public title
The late follow-up endoscopy as bleeding prevention after the gastric endoscopic submucosal dissection in the patient with thienopyridine derivative or low-dose aspirin and warfarin combination
Acronym
ESD follow-up endoscopy Hokuriku Study
Scientific Title
The late follow-up endoscopy as bleeding prevention after the gastric endoscopic submucosal dissection in the patient with thienopyridine derivative or low-dose aspirin and warfarin combination
Scientific Title:Acronym
ESD follow-up endoscopy Hokuriku Study
Region
| Japan |
Condition
Condition
Gastric adenoma or early gastric cancer(cStage IA)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the necessity of late follow-up endoscopy as bleeding prevention after the gastric endoscopic submucosal dissection in the patient with thienopyridine derivative or low-dose aspirin and warfarin combination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the incidence of bleeding rates after ESD between late endoscopy group and no late endoscopy group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
late follow-up endoscopy group (A group)
Interventions/Control_2
non-follow-up endoscopy group (B group)
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. treatment before endoscopic diagnosis, it has been diagnosed with stomach adenomas or early gastric cancer of clinical stage IA.
2. single multiple is not limited, but the endoscopic treatment plan lesions are only one lesion.
3. thienopyridine derivatives those who are taking, or low-dose aspirin and warfarin in combination with those who are taking
4. Gender: unquestioned, Age: persons age at the time of consent acquisition is greater than or equal to 20 years of age
5. PS ECOG is either 0, 1, 2.
6. all satisfy the following condition.
hemoglobin 9g/dl~
platelet count 100,000 / mm3~
AST/ALT ~100
serum creatinine ~2.0mg / dl
PT-INR% 80%~
Key exclusion criteria
1. there is a registration history in this study.
2. including for other carcinomas, there is a history of radiation therapy to the upper abdomen.
3. esophageal lesions, there is a plan of endoscopic therapy at the same time against duodenal lesions.
4. within registration before the 28th there is the endoscopic treatment history with respect to the upper gastrointestinal tract lesions.
5. within 28 days after treatment is scheduled to undergo an endoscopic examination or treatment with respect to the upper gastrointestinal tract.
6. continuous systemic administration of antiplatelet or anticoagulant agents other than low-dose aspirin and warfarin or thienopyridine, or steroids.
7. temporary interruption of non-steroidal anti-inflammatory drugs is impossible from ESD treatment 7 days up to 28 days after ESD treatment.
8. childbearing potential during pregnancy or lactating women.
9. have a psychosis or mental symptoms.
10. activity of bacterial and fungal infections.
11. merged the poor control of hypertension.
12. merged the respiratory disease requiring sustained oxygen administration.
13. principal investigator or researcher has determined to be inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoneshima |
Organization
Municipal Tsuruga Hospital
Division name
Department of gastroenterology
Zip code
Address
Mishima-cho 1-6-10, Tsuruga, Fukui, Japan
TEL
0770-22-3611
ts247686@ton21.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Hayashi |
Organization
Kanazawa University Hospital
Division name
Department of gastroenterology
Zip code
Address
Takaramachi13-1, Kanazawa, Ishikawa, Japan
TEL
076-265-2235
Homepage URL
hayasix0917@gmail.com
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society Hokuriku Chapter
Institute
Department
Personal name
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
Address
Tel
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
| 2015 | Year | 02 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019136
