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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016475
Receipt No. 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

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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
Email 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
Email hayasix0917@gmail.com

Sponsor
Institute Japan Gastroenterological Endoscopy Society Hokuriku Chapter
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019136

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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