UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035353 |
|---|---|
| Receipt number | R000040175 |
| Scientific Title | Non-randomized confirmatory study of dabigatran bridge therapy in perioperative period of ESD for gastric neoplasms in patients on anticoagulant |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2024/12/27 14:14:17 |
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Basic information
Public title
Non-randomized confirmatory study of dabigatran bridge therapy in perioperative period of ESD for gastric neoplasms in patients on anticoagulant
Acronym
Dabigatran bridge therapy for gastric ESD
Scientific Title
Non-randomized confirmatory study of dabigatran bridge therapy in perioperative period of ESD for gastric neoplasms in patients on anticoagulant
Scientific Title:Acronym
Dabigatran bridge therapy for gastric ESD
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the short term outcome of dabigatran bridge therapy in perioperative period of ESD for gastric neoplasms for the cases with anticoagulants(warfarin, rivaloxaban, or apixaban)for non valvlar antral fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Delayed bleeding rate of all registered cases
Key secondary outcomes
THe rate of throbmbotic events of all cases, Delayed bleeding rate for each cases, The duration of hospitalization, The rate of severe complications.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
In the perioperative period, we change the anticoagulant (warfarin, rivaroxaban, apixaban, edoxaban) to dabigatran and performe ESD to gastric neoplasms.
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
1 Having gastric cancer indicated ESD according to Japanese guideline
2 Over 20 years old
3 Performance status of 0-3
4 Having non- valvular Af in CHADS-2 score of 0-4
5 Taking warfarin, rivaroxaban, or apixaban continuously for prophylactics of thrombotic events, over 28 days before registration
6 Patients on antiplatelet agents such as aspirin or thienopyridine are not excluded.
7 Over 30 mL/min of CCr (or over 30mL/min/1.73m2 of EGFR) in examination within 56 days from registration
8 Over 10g/dl of Hb and over 5x104/mm3 of platelet count within 56 days from registration without transfusion in 14 days.
9 Able to observe patient for 56 days after ESD
10 Obtained a consent from prescribing doctor of anticoagulant
11 Obtained a consent from the patient
Key exclusion criteria
1 Patients with non-valvular Af in CHADS2 score of 5 or 6
2 Have allergy for dabigatran
3 Have a plan to perform endoscopic resection for esophageal or duodenal lesion simultaneously
4 Had endoscopic treatment within 28 days from registration
5 Have infection requiring systemic treatments
6 Being or possible pregnant
7 Having psychiatric disorder and judged unsuitable for the clinical study.
8 Continuous systemic use of steroid
9 Using itraconazole which is contraindications of combination with dabigatran
10 Unstable angina (newly occurring or a worsening over the 3 weeks prior to ESD) or myocardial infarction within 6 months prior to ESD
11 Severe respiratory disease requiring continuous oxygen supply
12 Uncontrollable hypertension
13 Uncontrollable diabetes mellitus
14 Patients judged unsuitable for clinical study by investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yoshio |
Organization
Cancer Institute Hospital
Division name
Department of Gaastoroenterology
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
toshiyuki.yoshio@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Yoshio |
Organization
Cancer Institute Hospital
Division name
Gastroenterology
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
toshiyuki.yoshio@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for research and promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cncer Institute Hospital
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
03-3520-0111
keiko.ohta@jfcr.or.jp
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
斗南病院(北海道)、国立病院機構函館病院(北海道)、弘前大学医学部附属病院(青森県)、東北大学病院(宮城県)、仙台厚生病院(宮城県)、国立国際医療研究センター国府台病院(千葉県)、国立がん研究センター中央病院(東京都)、慶応義塾大学(東京都)、虎の門病院(東京都)、がん研有明病院(東京都)、名古屋大学医学部附属病院(愛知県)、石川県立中央病院(石川県)、金沢大学附属病院(石川県)、
福井県立病院(福井県)、市立豊中病院(大阪府)、大阪市立総合医療センター(大阪府)、JCHO大阪病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大阪市立大学医学部附属病院(大阪府)、関西労災病院(兵庫県)、和歌山県立医科大学附属病院(和歌山県)、山口大学医学部附属病院(山口県)、愛媛大学医学部附属病院(愛媛県)、愛媛県立中央病院(愛媛県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040175
