UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029612
Receipt No. R000033757
Scientific Title The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Date of disclosure of the study information 2017/10/18
Last modified on 2020/03/20 (Ver. 7)

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Basic information
Public title The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Acronym The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Scientific Title The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Scientific Title:Acronym The prospective multicenter observational study of tissue acquisition by endoscopic ultrasound-guided fine-needle aspiration using the 25-gauge Franseen needle
Region
Japan

Condition
Condition Lesions with Indication for EUS-FNA
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of EUS-FNA using the 25-gauge Franseen needle in pathological diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The tissue acquisition rate in the initial puncture
Key secondary outcomes (1) Quality of a tissue sample
(2) Diagnostic accuracy
Diagnostic accuracy, sensitivity, specificity, PPV, NPV in (3) pathological and (4) cytological malignancy or benignancy
(5) Success rate of puncture
(6) Adverse event rate in EUS-FNA

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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Age =or >20
(2) Requirement of EUS-FNA of a solid lesion
(3) Use of the 25-gauge Franseen needle
(4) Providing written informed consent
Key exclusion criteria (1) Cystic lesion
(2) PT-INR =or >1.5
(3) Platelate count < 50000/m3
(4) ASA =or >3
(5) ECOG-PS=4
(6) Pregnancy
(7) Unsuitable for inclusion at the discretion of the physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code 060-8648
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-716-1161
Email mkuwatan@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Sugiura
Organization Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email rsugiura-hok@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
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 Institutional Review Board of Hokkaido University Hospital
Address North 14, West 5, Kita-ku, Sapporo
Tel 011-706-7636
Email crjimu@huhp.hokudai.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
2017 Year 10 Month 18 Day

Related information
URL releasing protocol http://www.eusjournal.com/preprintarticle.asp?id=254011
Publication of results Published

Result
URL related to results and publications http://www.eusjournal.com/preprintarticle.asp?id=254011
Number of participants that the trial has enrolled 100
Results 
The patients were 57 males and 43 females with a median age of 70 years. The technical success rate was 100 %. The tissue acquisition rate at the first pass was 95.0 % and the acquisition rate of an adequate specimen for histological assessment was 82.0 %. The sensitivity, specificity, PPV, NPV and diagnostic accuracy were 87.0 %, 100 %, 100 %, 40.0 % and 88.0 %, respectively. The adverse event rate was 1.0 %, the detail of which was 1 moderate pancreatic fistula.
Results date posted
2019 Year 05 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients with a solid lesion who required EUS-FNB for a diagnosis.
Participant flow 
Patients with a solid lesion who required EUS-FNB for a diagnosis were registered. All patients provided written informed consent.
Adverse events 
There was 1 adverse event in 1 patient (1.0 %), who  underwent transgastric puncture.
Outcome measures 
The primary outcome of the current study was a tissue acquisition rate in the initial pass. The secondary outcomes were an acquisition rate of an adequate specimen for histological assessment, quality of the tissue sample, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy of EUS-FNB, success rate of puncture, and adverse event rate.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 18 Day
Date of IRB
2017 Year 08 Month 31 Day
Anticipated trial start date
2017 Year 08 Month 31 Day
Last follow-up date
2018 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Patient characteristics: age, gender, Performance status, commorbidity
2) Evaluation of the tumor: imaging (abdominal roentgenogram, CT, MRI, US, EUS)
3) Pathological findings of EUS-FNA specimen (diagnosis, sample quantity, sample quality, blood amount)
4) Procedure characteristics of EUS-FNA (target, puncture site, success rate, number of puncture, procedure time, with or without rapid on-site evaluation)
5) Adverse events of EUS-FNA
6) Hematological findings: WBC, Hb, Plt, blood fraction
7) Chemistry: ALP, total billirubin, Alb, AST, ALT, gamma-GT, total protein, LDH, creatinine, BUN, amylase, lipase, CRP
8) Coagulation: PT activity(%), PT-INR
9) Pathological findings of surgical specimen or biopsy specimen by ERCP

Management information
Registered date
2017 Year 10 Month 18 Day
Last modified on
2020 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033757