UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053830 |
|---|---|
| Receipt number | R000061393 |
| Scientific Title | Prospective observational study to determine the incidence of hospital admissions due to post-operative bleeding in outpatient treatment of endoscopic submucosal dissection for gastric tumours. |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 16:53:57 |
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Basic information
Public title
Prospective observational study to determine the incidence of hospital admissions due to post-operative bleeding in outpatient treatment of endoscopic submucosal dissection for gastric tumours
Acronym
Observational study to determine the incidence of hospital admissions due to postoperative bleeding in outpatient gastric ESD
Scientific Title
Prospective observational study to determine the incidence of hospital admissions due to post-operative bleeding in outpatient treatment of endoscopic submucosal dissection for gastric tumours.
Scientific Title:Acronym
Prospective observational study to determine the incidence of hospital admissions due to post-operative bleeding in outpatient gastric ESD
Region
| Japan |
Condition
Condition
Gastric epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of outpatient endoscopic submucosal dissection (ESD; endoscopic submucosal dissection) for gastric tumors and mucosal defect closure using endoscopic hand suturing (EHS).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hospital admissions due to post-operative bleeding
Key secondary outcomes
Procedure outcomes (Resection rate, success rate of closure, procedure time, incidence of intra-operative adverse events), incidence of post-operative adverse events, total medical costs incurred during treatment and within 28 days after treatment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients planning to undergo gastric ESD and closure of post-ESD mucosal defect using endoscopic hand suturing (EHS) as an outpatient treatment
2. Preoperative diagnosis of gastric cancer or gastric adenoma (including suspected) of 3 cm or less
3. No endoscopic findings that suggest submucosal invasion
4. Patients aged between 20 and 85 years at the time of consent
5. Patients who give written consent to participate in this study
Key exclusion criteria
1. Patients treated for multiple lesions at the same time (patients with multiple lesions, including those of other organs, can be included if only one lesion is treated during the protocol treatment period).
2. Patients with a history of previous gastrectomy.
3. Severe organ failure (heart, lung, liver, kidney, bone marrow).
4. Patients with lesions located on areas considered extremely difficult to treat (gastric fornix, pylorus)
5. Patients who cannot be managed perioperatively with antithrombotic agents according to the guidelines of the Japanese Gastrointestinal Endoscopy Society
6. A case that the attending physician determines that patient is not suitable for this study
7. A case that patient refuses to participate in this study after enrollment.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Akimoto |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3437
Homepage URL
t-akimoto@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Olympus Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061393
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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