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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035353
Receipt No. 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 2019/06/24

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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) 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
Email 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
Email toshiyuki.yoshio@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Institute
Department

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
Email 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

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 Preinitiation
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
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 23 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040175

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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