UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020850 |
|---|---|
| Receipt number | 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 23:31:46 |
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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
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
isaitou-nms@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital Department of Gastroenterology, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024062
