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

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 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


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

Value
https://center6.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