UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013393 |
|---|---|
| Receipt number | R000014929 |
| Scientific Title | A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA |
| Date of disclosure of the study information | 2014/03/12 |
| Last modified on | 2022/07/09 22:00:34 |
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Basic information
Public title
A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA
Acronym
A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA
Scientific Title
A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA
Scientific Title:Acronym
A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA
Region
| Japan |
Condition
Condition
pancreatic mass
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is evaluating the efficacy of back light system "BIOEVALUATOR" for picking up specimens in EUS-FNA by endosonographers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The adequacy rate in each group.
Key secondary outcomes
Gross visual assessment of specimen adequacy, accuracy rate of EUS-FNA and adequacy rates of each time in each endosonographer.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In EUS-FNA, 1st puncture picking up specimen with BIOEVALUATOR and 2nd puncture without it.
Interventions/Control_2
In EUS-FNA, 1st puncture picking up specimen without BIOEVALUATOR and 2nd puncture with it.
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
Patients with pancreatic mass who are refered to EUS-FNA
Key exclusion criteria
Patients with pancreatic mass which we cannot detect by EUS
Patients with severe ascites
Patients with other fatal disease
Patients who have risk of bleeding
Patients who do not agree to participate in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Harada |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL
086-235-7219
Homepage URL
rharada927@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
Okayama University
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
Tel
086-223-7151
MAE6605@adm.okayama-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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014929
Publication of results
Published
Result
URL related to results and publications
https://www.e-ce.org/journal/view.php?doi=10.5946/ce.2019.004
Number of participants that the trial has enrolled
80
Results
A total of 80 consecutive patients were eligible during the study period. Adequacy was observed for 52 specimens (65%) with the BLS and 54 (68%) without the BLS (p=0.88). In assessment of specimen adequacy on gross examination, only fair agreement was observed both with and without BLS (kappa score 0.40 and 0.29, respectively).
Results date posted
| 2019 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 16 | Day |
Baseline Characteristics
Median age was 67 years; there were 30 females and 50 males. In terms of location, 38 of tumors were found in the pancreatic head, 25 in the pancreatic body, and 17 in the pancreatic tail. The median size of lesions was 27 mm in the long axis and 20 mm in the short axis. All 80 patients underwent EUS-FNA. A median of 3 FNA passes per patient was performed on the pancreatic mass. EUS-FNA was performed via the stomach in 45 patients and via the duodenum in 35.
Participant flow
To control the variables that could influence study results, we randomized the patients using a crossover design for BLS use or non-use in the first and second passes. Randomization was performed immediately after the endosonographer detected the pancreatic mass. An individual other than the endosonographer performing the EUS-FNA used biased-coin randomization to allocate cases to the groups. Randomization was performed in a 1:1 ratio.
Adverse events
There was no bleeding or perforation with EUS-FNA in this series. Mild pancreatitis occurred in 1 patient with pancreatic head cancer; however, this resolved with conservative therapy and prolonged the hospital stay by only 1 night.
Outcome measures
1)Adequacy rate in the BLS and non-BLS groups
2)Gross visual assessments of specimen adequacy
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014929
