UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045906 |
|---|---|
| Receipt number | R000052406 |
| Scientific Title | Efficacy of endoscopic ligation with O-ring closure for preventing gastric post- endoscopic submucosal dissection bleeding under antithrombotic therapy: A prospective study |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2021/10/28 20:46:58 |
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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
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
nishiyama.noriko@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052406
