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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name