UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056514 |
|---|---|
| Receipt number | R000064584 |
| Scientific Title | Evaluation of the Utility of Modified Mucosal Incision-Assisted Biopsy Using the Unroofing Technique with Cold Snare for Subepithelial Lesions of the Stomach |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/20 13:40:05 |
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Basic information
Public title
Evaluation of the Utility of Modified Mucosal Incision-Assisted Biopsy Using the Unroofing Technique with Cold Snare for Subepithelial Lesions of the Stomach
Acronym
EUMISEL
Scientific Title
Evaluation of the Utility of Modified Mucosal Incision-Assisted Biopsy Using the Unroofing Technique with Cold Snare for Subepithelial Lesions of the Stomach
Scientific Title:Acronym
EUMISEL
Region
| Japan |
Condition
Condition
Gastric subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The diagnostic ability of modified MIAB for gastric SEL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation rate
Key secondary outcomes
Incidence of complications, procedure time, number of punctures/biopsies, and the maximum surface area of the obtained tissue samples
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with gastric SEL and capable of providing informed consent.
Key exclusion criteria
Patients suspected of having submucosal tumor-like cancer.
Patients with significant decreases in coagulation ability or platelet count.
Patients who have expressed a wish not to use their information or materials.
Patients deemed unsuitable for the study by the attending physician based on underlying diseases, age, ADL, gastric SEL size, and other factors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | yohsitaka |
| Middle name | |
| Last name | ando |
Organization
Atsugi City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
243-8588
Address
Atsugi City Hospital. 1-16-36, Atsugi-shi, Kanagawa
TEL
046-221-1570
yoshitaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | yoshitaka |
| Middle name | |
| Last name | ando |
Organization
Atsugi City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
243-8588
Address
Atsugi City Hospital. 1-16-36, Atsugi-shi, Kanagawa
TEL
046-221-1570
Homepage URL
yoshitaka@jikei.ac.jp
Sponsor or person
Institute
Atsugi City Hospital
Institute
Department
Personal name
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
Atsugi City Hospital
Address
Atsugi City Hospital. 1-16-36, Atsugi-shi, Kanagawa
Tel
046-221-1570
2480@city.atsugi.kanagawa.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 | 12 | Month | 25 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | 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
[Methods and Duration of the Study]
Single-center, prospective observational study.
This study will target patients diagnosed with gastric SEL who visited Atsugi City Hospital, and will conduct a prospective analysis. Data will be collected from medical records and test reports, including age, sex, comorbidities, concomitant medications, height, weight, final survival confirmation date, death status during follow-up, lesion location, lesion size, types and numbers of medical devices used, methods of tissue specimen collection, puncture needle size, number of punctures (number of biopsies for both boring biopsy and modified MIAB), procedure time, maximum surface area of obtained tissue samples, pathological diagnosis, ulcer base treatment methods, surgical procedures and final diagnosis if surgery was performed, and the type, severity, management, and outcome of any complications. The study will compare three groups: those who underwent endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), those who underwent boring biopsy, and those who underwent modified MIAB. Since the study will be conducted as part of routine clinical care, the choice of biopsy method will be made based on the physician's judgment and patient preferences.
The primary outcome measure will be the confirmation rate of diagnosis, and secondary outcome measures will include the incidence of complications, procedure time, number of punctures/biopsies, and the maximum surface area of obtained tissue samples. Each of these will be analyzed. Additionally, propensity score matching will be performed between the three groups based on patient background to minimize bias and allow for comparison. Furthermore, multivariate analysis using logistic regression will be conducted to examine factors related to diagnostic ability, such as lesion location and tissue diagnosis.
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064584
