UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029612 |
|---|---|
| Receipt number | 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 11:54:57 |
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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
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
rsugiura-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033757
