UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037543 |
|---|---|
| Receipt number | R000042808 |
| Scientific Title | Validation study for the diagnosis of Sessile Serrated Lesion in JNET type 1 lesions. |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2024/01/31 18:39:23 |
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Basic information
Public title
Validation study for the diagnosis of Sessile Serrated Lesion in JNET type 1 lesions.
Acronym
VSSL1 study
Scientific Title
Validation study for the diagnosis of Sessile Serrated Lesion in JNET type 1 lesions.
Scientific Title:Acronym
VSSL1 study
Region
| Japan |
Condition
Condition
Sessile serrated lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the diagnostic performance of sessile serrated lesion in JNET type1 by using NBI with optical magnification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the diagnostic performance of sessile serrated lesion in JNET type1 by using NBI with optical magnification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
All JNET type 1 lesions (more than 6mm) are treated by endoscopic resection.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients received total colonoscopy for screening or surveillance
Key exclusion criteria
1) Patients who are received colorectomy
2) Patients with IBD
3) Patients with any Polyposis
4) Patients with Anticoagulant or antiplatelet
5) Pregnant woman and Breastfeeding women
6) Patients with severe illness
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Daizen |
| Middle name | |
| Last name | Hirata |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
655-0031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
TEL
0787851000
daizenhirata@gmail.com
Public contact
Name of contact person
| 1st name | Daizen |
| Middle name | |
| Last name | Hirata |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
655-0031
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
TEL
0787851000
Homepage URL
daizenhirata@gmail.com
Sponsor or person
Institute
Sano Hospital
Institute
Department
Personal name
Funding Source
Organization
Sano Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kindai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sano hospital institutional review board
Address
2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
Tel
0787851000
yonedarieko@gmail.com
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
佐野病院（兵庫県）、近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
https://karger.com/dig/article/104/4/262/836235/A-Multicenter-Prospective-Validation-Study-on
Publication of results
Published
Result
URL related to results and publications
https://karger.com/dig/article/104/4/262/836235/A-Multicenter-Prospective-Validation-Study-on
Number of participants that the trial has enrolled
185
Results
The sensitivity of magnifying colonoscopy in detecting SSLs was 79.8% (95% confidence interval 74.7-84.4%) overall, and 82.4% (76.1-87.7%) in the high-confidence group. These results showed that the sensitivity of this study was not high enough, even limited in the high-confidence group.
Results date posted
| 2021 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 01 | Month | 17 | Day |
Baseline Characteristics
The patients mean age was 65.7 years, and the male/female ratio was 89/73. A total of 146 lesions (67.3%) were in the right colon. The mean diameter of JNET type 1 lesions was 9.5 mm, and 148 lesions (68.2%) were between 6 and 9 mm.
Participant flow
In four institutions, 4,397 and 4,336 patients were recruited and admitted, respectively, between December 2019 and October 2020. Among them, 241 lesions from 185 cases were enrolled and no cases were denied enrollment. One lesion was excluded due to ineligibility, and 23 lesions were excluded due to nonserrated histology, eventually including 217 JNET type 1 lesions from 162 cases in the final analysis.
Adverse events
No events
Outcome measures
For examining the validity of selective endoscopic resection of SSLs using magnifying colonoscopy in clinical practice, we used the sensitivity of endoscopic diagnosis of SSLs in JNET type1 lesion more than 6 mm in the analysis. Since it is clinically important to prevent leaving SSLs on site, the sensitivity of endoscopic diagnosis was at most suitable measure for the description. The diagnostic performance, such as specificity, positive predictive value, and negative predictive value of SSLs in JNET type 1 lesions more than 6 mm was also calculated by comparing the endoscopic diagnosis with the histopathological diagnosis as the gold standard. The usefulness of the differential diagnosis was statistically analyzed and judged by whether the upper limit of the 95% confidence interval (CI) for sensitivity reached 90%. If the upper limit of the 95% CI for sensitivity did not reach 90%, the differential diagnosis is not sensitive enough, and selective endoscopic resection is not recommended due to the risk of leaving more than 10% SSLs on site.
Plan to share IPD
N/A
IPD sharing Plan description
N/A
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042808
