UMIN-CTR Clinical Trial

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
Institute	Yokohama City University Medical Center
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029468