UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030879 |
|---|---|
| Receipt number | R000035256 |
| Scientific Title | Management of cessation periods after endoscopic hemostasis for patients with non-variceal upper gastrointestinal bleeding taking anti-thrombotic agents : A multi-center pilot study |
| Date of disclosure of the study information | 2018/01/22 |
| Last modified on | 2021/06/07 14:50:26 |
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Basic information
Public title
Management of cessation periods after endoscopic hemostasis for patients with non-variceal upper gastrointestinal bleeding taking anti-thrombotic agents : A multi-center pilot study
Acronym
Cessation study
Scientific Title
Management of cessation periods after endoscopic hemostasis for patients with non-variceal upper gastrointestinal bleeding taking anti-thrombotic agents : A multi-center pilot study
Scientific Title:Acronym
Cessation study
Region
| Japan |
Condition
Condition
non-variceal upper gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety of non-cessation periods after endoscopic hemostasis for patients with non-variceal upper gastrointestinal bleeding taking anti-thrombotic agents
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rebleeding rate after endoscopic hemostasis within one month
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Endoscopic Hemostasis
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
Indications for emergency upper gastrointestinal endoscopy included hematemesis, melena, and rapidly progressive anemia.
Key exclusion criteria
Patients with variceal bleeding
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
Ureshino city shimojyukukou 4279-3
TEL
0954431120
yamaguchi-sag@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Hospital Organization Ureshino Medical Center
Division name
Gastroenterology
Zip code
843-0393
Address
Ureshino city shimojyuku hei 2436
TEL
0954431120
Homepage URL
yamaguchi-sag@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Ureshino Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Ureshino Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Ureshino Medical Center
Address
4279-3 Shimojyukukou Ureshino city
Tel
0954431120
sonoda-m@uresino.go.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
| 2018 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.hindawi.com/journals/cjgh/2021/6672440/
Publication of results
Published
Result
URL related to results and publications
https://www.hindawi.com/journals/cjgh/2021/6672440/
Number of participants that the trial has enrolled
43
Results
Endoscopic hemostasis was successful in all patients and the incidence of rebleeding within a month was 7.0%. Propensity score matching created 40 matched pairs. Endoscopic hemostasis was performed by soft coagulation significantly more frequently in group A than in group B. Neither the rebleeding rate within a month nor thromboembolic event rate was different between the two groups. However, the mean duration of hospitalization was significantly shorter in group A than in group B.
Results date posted
| 2021 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who had undergone emergency endoscopy and endoscopic hemostasis for nonvariceal UGIB from February 2018 through October 2019 at participating institutions were enrolled.
Patients　above　20 years of age who fulfilled the following criteria were candidates for the study: (1) underwent endoscopic hemostasis within 24h of symptom onset; (2) used antithrombotic agents, including antiplatelet agents and anticoagulants; and (3) had a clear level of consciousness as well as stable respiratory and circulatory dynamics. Patients with variceal bleeding were excluded.
Participant flow
All patients in the prospective cohort resumed antithrombotic agents after emergency endoscopic hemostasis without a cessation period (group A).
In the present study, we used the clinical data of our retrospective cohort of 154 patients on antithrombotic treatment who underwent emergency endoscopic hemostasis for nonvariceal UGIB from January 2002 through December 2013 at Saga Medical University Hospital as group B. These patients were similarly treated but antithrombotic agents were transiently discontinued after endoscopic hemostasis in accordance with the JGES guideline at that time.
Adverse events
Rebleeding occurred in three patients (7.0%); however, neither major thromboembolic events nor fatalities were recorded during the follow-up period.
Outcome measures
Antithrombotic agents possibly can be continued after successful emergency endoscopic hemostasis for nonvariceal UGIB.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | 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 | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035256
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