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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013393
Receipt No. 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

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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
Email 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
Email rharada927@yahoo.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014929

Research Plan
Registered date File name
2019/05/30 ④臨床試験計画書第3版.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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