UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053726 |
|---|---|
| Receipt number | R000061306 |
| Scientific Title | A prospective study of the effect of wound closure on prevention of posterior bleeding for ulcers after endoscopic submucosal dissection (ESD) in patients taking oral antithrombotic medications |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/08/30 16:40:21 |
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Basic information
Public title
A prospective study of the effect of wound closure on prevention of posterior bleeding for ulcers after endoscopic submucosal dissection (ESD) in patients taking oral antithrombotic medications
Acronym
ESD study
Scientific Title
A prospective study of the effect of wound closure on prevention of posterior bleeding for ulcers after endoscopic submucosal dissection (ESD) in patients taking oral antithrombotic medications
Scientific Title:Acronym
ESD study
Region
| Japan |
Condition
Condition
Early Stage Gastric Cancer/Gastric Tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the safety of gastric ESD under continuous antithrombotic medication and to determine the efficacy and safety of wound closure using the MANTIS Closure Device and EZ clip for gastric post-ESD ulcers to prevent posterior bleeding.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
posterior hemorrhage
Key secondary outcomes
(1) Intraoperative bleeding control
(2) Lump-sum complete resection rate, lump-sum curative resection rate, lump-sum resection rate
(3) MANTIS Closure Device residual duration and residual rate.
(4) Incidence of thromboembolism in the perioperative period.
(5) Resection time
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
Suture/close the ulcer bottom after gastric ESD using the MANTIS Closure Device, EZ clip.
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) Early stage gastric cancer diagnosed by preoperative endoscopy as an absolute indication for endoscopic resection or an extended indication according to the guidelines for gastric cancer treatment.
(2) Early-stage gastric cancer with no clinical metastasis diagnosed by CT, echography, or other imaging methods.
(3i) Male and female patients aged 20 years or older at the time of consent, who have given their written consent.
Key exclusion criteria
(1) Patients have active multiple cancers. However, intraepithelial or intramucosal carcinoma that can be cured by endoscopic treatment is eligible.
(2) The patient has the following serious complications: (i) Serious hepatic disorder
Serious hepatic disorder
Serious cardiac disease (myocardial infarction, angina pectoris, congestive heart failure, etc.)
Serious renal disorder
(3) Serious infectious disease.
(4) Women who are pregnant or may become pregnant. Women who are lactating.
(5) Patients with serious bleeding or in shock.
(6) Patients with bleeding tendency.
(7) Patients who are currently participating in another clinical trial or for whom at least 3 months have not elapsed since the completion of the trial.
(8) Other patients whom the investigators/associate investigators deem inappropriate as subjects.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki University Hospital
Division name
Department of Endoscopy
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7489
kohei3100810@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Sato |
Organization
Nagasaki University Hospital
Division name
gastroenterology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7481
Homepage URL
kohei3100810@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki 852-8501, Japan
Tel
095-819-7726
rinshou7726@umin.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
| 2024 | Year | 02 | 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
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061306
