UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of endoscopic ligation with O-ring closure for preventing gastric post- endoscopic submucosal dissection bleeding under antithrombotic therapy: A prospective study
Acronym	Efficacy of E-LOC for preventing gastric post- endoscopic submucosal dissection bleeding
Scientific Title	Efficacy of endoscopic ligation with O-ring closure for preventing gastric post- endoscopic submucosal dissection bleeding under antithrombotic therapy: A prospective study
Scientific Title:Acronym	Efficacy of E-LOC for preventing gastric post- endoscopic submucosal dissection bleeding
Region	Japan

Condition
Condition	gastric lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examined the efficacy of our endoscopic ligation technique with O-ring closure (E-LOC) to prevent post-ESD bleeding.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of post-ESD bleeding with E-LOC
Key secondary outcomes	Complete defect closure rate Procedure time for closure Sustained closure rate Complications after E-LOC

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	Maneuver
Interventions/Control_1	Closure with E-LOC method
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	The inclusion criteria were treatment by ESD for early gastric carcinoma or adenoma that could not be preoperatively distinguished from early gastric carcinoma based on the Japanese Gastroenterological Endoscopy Society (JGES) criteria, current therapy with at least one antithrombotic drug.
Key exclusion criteria	Pyloric ring or cardia lesion Lesion involving more than half-circumference of the stomach
Target sample size	55

Research contact person
Name of lead principal investigator	1st name NORIKO Middle name Last name NISHIYAMA
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterology and Neurology
Zip code	7610793
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878985111
Email	nishiyama.noriko@kagawa-u.ac.jp

Public contact
Name of contact person	1st name NORIKO Middle name Last name NISHIYAMA
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterology and Neurology
Zip code	7610793
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878985111
Homepage URL
Email	nishiyama.noriko@kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Kagawa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa University
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
Tel	0878985111
Email	nishiyama.noriko@kagawa-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 28 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	2019 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 30 Day
Last follow-up date	2022 Year 10 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 28 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052406