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Recruitment status
Unique ID issued by UMIN UMIN000020850
Receipt No. R000024062
Scientific Title A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Date of disclosure of the study information 2016/02/04
Last modified on 2018/02/12

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Basic information
Public title A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Acronym A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Scientific Title A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Scientific Title:Acronym A prospective exploratory study on the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Region
Japan

Condition
Condition The lesion that is indicated in gastric endoscopic submucosal dissection in patients who use warfarin for prevention of thrombosis.
Classification by specialty
Medicine in general Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the safety of gastric endoscopic submucosal dissection without cessation of warfarin.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The bleeding rate after gastric endoscopic submucosal dissection from immediately until the 28th day
Key secondary outcomes 1.The existence of bleeding requiring hemostatic procedure in second-look gastrointestinal endoscopy (day1).
2.Early bleeding rate after gastric endoscopic submucosal dissection (from immediately after gastric endoscopic submucosal dissection to before the day2 meal starts).
3.Delayed bleeding rate after gastric endoscopic submucosal dissection (after the day2 meal started).
4.Duration of hospitalization.

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
Interventions/Control_1 In patients who use warfarin for prevention of thrombosis, gastric endoscopic submucosal dissection will be done without cessation of warfarin. Protocol treatment period in this study is from the day of gastric endoscopic submucosal dissection (day0) to the 28th day after gastric endoscopic submucosal dissection (day28). Observation period is from the registration to the protocol to the end of protocol treatment period.
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 with non valvular atrial fibrillation, and use warfarin for prevention of thrombosis. Patients' PS (Performance Status) is 0-2 of ECOG(Eastern Cooperative Oncology Group), and over 20 years old age.
(1)The target is the lesion that is indicated in endoscopic submucosal dissection in Japanese classification of gastric carcinoma: 4th Japanese edition 2014.
(2)
a)In patients with non valvular atrial fibrillation, PT-INR has to be confirmed following values in blood collection within 3days before the treatment.
Less than 70 years of age: PT-INR is less than 3
70 years of age or older: PT-INR is less than 2.6
b)In patients using warfarin for the prevention of deep vein thrombosis or pulmonary embolism, PT-INR has to be confirmed following values in blood collection within 3days before the treatment.
PT-INR is less than 2.5
c)In patients with artificial heart valve, PT-INR has to be confirmed following values in blood collection within 3days before the treatment.
PT-INR is less than 3.0
(3)Estimated glomerular filtration (eGFR) is confirmed greater than or equal to 30mL/min/1.73m2 within 60 days prior to registration.
(4)After the patient has received a sufficient explanation on participation in this study, informed consent has been obtained by the free will of the patient.
(5)It is possible to follow the course of more than 28 days after treatment.
(6)All the following test data using the latest test values within 60 days prior to registration is met.
1) Hb is 9g/dl or more
2) Plt is 100000/mm3 or more
3) AST, ALT is less than 100IU/L
Key exclusion criteria (1)Women who has a possibility of pregnancy or is during pregnancy
(2)Women who has baby and is nursing
(3)Patients who undergo hemodialysis
(4)To assess the general condition and complications of patients, if the attending physician has determined that it is difficult to entry.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ono
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology, Graduate School of Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Email satoshi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Itaru Saito
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology, Graduate School of Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-3815-5411
Homepage URL
Email isaitou-nms@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Institute
Department

Funding Source
Organization The clinical research insurance is covered by Grant-in-Aid for Scientific Research- Young Scientists (B) (Principal Investigator: Satoshi Ono, project number: 127100000551).
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 02 Month 04 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
Date of protocol fixation
2015 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 02 Day
Last modified on
2018 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024062

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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