UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037494 |
|---|---|
| Receipt number | R000042584 |
| Scientific Title | The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial |
| Date of disclosure of the study information | 2019/07/25 |
| Last modified on | 2025/07/29 09:15:29 |
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Basic information
Public title
The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial
Acronym
The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions
Scientific Title
The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions-Randomized controlled trial
Scientific Title:Acronym
The efficacy of ultrasound guided fine-needle biopsy using the clip-with-thread method for small gastric subepithelial lesions
Region
| Japan |
Condition
Condition
gastric subepithlial lesion
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of tissue sampling
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic ultrasound guided fine-needle biopsy using the clip-with-thread method
Interventions/Control_2
endoscopic ultrasound guided fine-needle biopsy without the clip-with-thread method
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. Patients who are diagnosed SMT and undergo eendoscopic ultrasound guided fine-needle biopsy.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
Key exclusion criteria
1. Patients who are judged as contraindication for endoscopy.
2. Patients who have metal allergy.
3. Patients who are judged as being inappropriate for this study by their medical doctor.
4. Patients from whom written informed consent is not obtained.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | eikichi |
| Middle name | |
| Last name | ihara |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+810926425082
eikichi@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu university
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
+810926425082
Homepage URL
yminoda@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
kyushu 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
Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
+810926425082
byskenkyu@jimu.kyushu-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
| 2019 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39789813/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39789813/
Number of participants that the trial has enrolled
30
Results
TA-EUS-FNB demonstrated superior tissue sampling rates and diagnostic yield for SELs <20 mm compared to conventional EUS-FNB, making it a viable option.
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean tumor size was 15.0 mm, with diagnoses comprising GISTs (n = 15, 50%), leiomyomas (n = 8, 26.7%), schwannomas (n = 2, 6.7%), aberrant pancreas (n = 3, 10%), and inflammation (n = 2, 6.7%).
Participant flow
We performed a prospective randomized cross-over comparison trial at Kyushu University Hospital, comparing TA-EUS-FNB with conventional EUS-FNB. In this study, patients were randomly assigned to one of two methods and underwent a total of four punctures: two with the assigned method and two with an alternative
Adverse events
no adverse events
Outcome measures
The primary end-point was the adequate tissue sampling rate for both techniques. Secondary end-points included diagnostic yield and performance (sensitivity and specificity) in distinguishing gastrointestinal stromal tumors (GISTs) from non-GISTs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042584
