UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025607 |
|---|---|
| Receipt number | R000029468 |
| Scientific Title | Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs -a prospective study- |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2022/01/16 11:10:44 |
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Basic information
Public title
Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
-a prospective study-
Acronym
Efficacy of third look endoscopy to prevent delayed bleeding after gastric ESD in patients with antithrombotic drugs
Scientific Title
Verification for the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
-a prospective study-
Scientific Title:Acronym
Efficacy of third look endoscopy to prevent delayed bleeding after gastric ESD in patients with antithrombotic drugs
Region
| Japan |
Condition
Condition
early gastric cancer / adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of third look endoscopy to prevent delayed postoperative bleeding after gastric endoscopic submucosal dissection in patients with antithrombotic drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall delayed bleeding rate
Key secondary outcomes
the early phase delayed bleeding rate
the late phase delayed bleeding rate
the delayed bleeding rate compared with the historical control group using propensity score matching.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To perform 3rd-look endoscopy 5days later after ESD
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)patients with histological diagnosis as gastric adenocarcinoma or adenoma
(2)patients without history of gastrectomy or esophagectomy
(3)patients with antithrombotic agents regardless of drug withdrawal
(4)PS(ECOG)0,1,2
(5) patients who can be followed up more than 28days after ESD
(6)patients with written informed consent of this study
Key exclusion criteria
(1) Patient with severe infection
(2) Patient who are pregnant, may be pregnant, or prefer pregnancy during treatment
(3)for Mental disease, dementia,it is difficult to participate study
(4) Patient with unstable angina, or myocardial infarction within 6 months.
(5)Patient with respiratory diseases requiring continuous oxygen therapy
(6)Patient with uncontrollable hypertension
(7)Patient with uncontrollable Diabetes
(8)anemia requiring transfusion(Hb<7.0g/dl), Easy to bleed for low platelet (Plt<50000)
(9) Patient judged inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kingo |
| Middle name | |
| Last name | hirasawa |
Organization
Yokohama City University Medical Center
Division name
Division of Endoscopy
Zip code
232-0024
Address
4-57, urahunecho, minami ward, Yokohama city, Kanagawa Prefecture
TEL
0452615656
ryosuke@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kingo |
| Middle name | |
| Last name | hirasawa |
Organization
Yokohama City University Medical Center
Division name
Division of Endoscopy
Zip code
232-0024
Address
4-57, urahunecho, minami ward, Yokohama city, Kanagawa Prefecture
TEL
0452615656
Homepage URL
ryosuke@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional review board of Yokohama City University
Address
3-9, fukuura, kanazawa ward, Yokohama city, Kanagawa Prefecture
Tel
045-370-7627
rinri@yokohama-cu.ac.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
横浜市立大学附属市民総合医療センター
Yokohama City University Medical Center
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.wjgnet.com/1007-9327/full/v26/i41/6475.htm
Publication of results
Published
Result
URL related to results and publications
https://www.wjgnet.com/1007-9327/full/v26/i41/6475.htm
Number of participants that the trial has enrolled
100
Results
In total, 96 patients and 114 specimens were finally evaluated. The overall PDB
rate was 7.9% (9/114) [90%CI: 4.7-13.1, P = 0.005], while the late-and early-onset
PDB rates (L-PDB and E-PDB) were 5.3% [90%CI: 2.7-9.9, P < 0.0001] and 2.6%
[90%CI: 1.1-6.4, P = 0.51], respectively.
Results date posted
| 2022 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
BACKGROUND
Postoperative delayed bleeding (PDB) after gastric endoscopic submucosal
dissection (ESD) is the most common adverse event in patients receiving
antithrombotics even with second-look endoscopy. Moreover, with the increasing
prevalence of cardiovascular and cerebrovascular diseases in an aging population
with associated lifestyle-related diseases, an increasing number of patients receive antithrombotics. Several attempts have been made to prevent PDB in aging
population; however, a consensus has yet to be reached
Participant flow
AIM
To examine the efficacy of third-look endoscopy (TLE) for PDB prevention.
METHODS
One hundred patients with early gastric neoplasms receiving antithrombotics
were prospectively enrolled and subjected to ESD with TLE between February
2017 and July 2019.
Adverse events
None
Outcome measures
The primary endpoint was PDB rate, which was compared with our preset threshold. Furthermore, we divided the bleeding period into early-and late-onset PDB (E-PDB and L-PDB, respectively) and analyzed its rate.
As a secondary analysis, we compared PDB rates with those of a historical control
group, using propensity score matching, and calculated the PDB rates per antithrombotic agent use in each group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2022 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029468
