UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054018 |
|---|---|
| Receipt number | R000061670 |
| Scientific Title | Mucosal incision-assisted biopsy of gastric subepithelial tumors: Systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/31 00:53:40 |
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Basic information
Public title
Diagnostic ability and adverse events of mucosal incision-assisted biopsy of gastric subepithelial tumors: Systematic review and meta-analysis
Acronym
Mucosal incision-assisted biopsy of gastric subepithelial tumors: Systematic review and meta-analysis
Scientific Title
Mucosal incision-assisted biopsy of gastric subepithelial tumors: Systematic review and meta-analysis
Scientific Title:Acronym
Mucosal incision-assisted biopsy of gastric subepithelial tumors: Systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Gastric submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted a systematic review and meta-analysis to further clarify the status of MIAB in Japan and seek appropriate prevention methods from adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the pathological diagnosis rate of MIAB for gastric subepithelial tumors. The pathological diagnosis rate was defined as the rate of pathological diagnoses that could be confirmed using the sampled tissue.
Key secondary outcomes
The secondary endpoint was the incidence of adverse events.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We performed a literature search using PubMed, Web of Science, and CENTRL databases and the following keywords: submucosal, subepithelial, gastrointestinal, mucosal cutting biopsy, MCB, mucosal incision-assisted biopsy, MIAB, single-incision needle-knife biopsy, and SINK. During screening, two authors independently selected relevant articles based on their titles and abstracts. Next, two authors read the full texts of the articles selected during screening to confirm whether they contained the necessary information based on the inclusion and exclusion criteria. The reference lists of the selected articles were also searched to find additional articles.
The inclusion criteria were information regarding diagnoses determined based on MIAB results and adverse events and either a prospective or retrospective study design. The exclusion criteria were as follows: written in a language other than English; society abstract; guidelines, protocol, case report, or meta-analysis; and referred to an organ other than the stomach. Additionally, when articles contained duplicate content, only the most recent one was included.
Key exclusion criteria
The exclusion criteria were as follows: written in a language other than English; society abstract; guidelines, protocol, case report, or meta-analysis; and referred to an organ other than the stomach. Additionally, when articles contained duplicate content, only the most recent one was included.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon medical school
Division name
Endoscopy center
Zip code
1138603
Address
Bunkyo-ku Sendagi 1-1-5
TEL
03382221
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Koizumi |
Organization
Nippon Medical School
Division name
Division of gastroenterology
Zip code
113-8603
Address
Bunkyo-ku Sendagi 1-1-5
TEL
03-3822-2131
Homepage URL
e-koizumi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Osamu Goto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
Bunkyo-ku, Sendagi, 1-1-5
Tel
0338222131
e-koizumi@nms.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 | 31 | 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 | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The inclusion criteria were information regarding diagnoses determined based on MIAB results and adverse events and either a prospective or retrospective study design. The exclusion criteria were as follows written in a language other than English, society abstract, guidelines, protocol, case report, or meta-analysis; and referred to an organ other than the stomach. Additionally, when articles contained duplicate content, only the most recent one was included.
Management information
Registered date
| 2024 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061670
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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