UMIN-CTR Clinical Trial

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