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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018359
Receipt No. R000021254
Scientific Title A multicenter prospective comparative crossover trial of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Date of disclosure of the study information 2015/07/20
Last modified on 2018/07/23

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Basic information
Public title A multicenter prospective comparative crossover
trial of endoscopic ultrasound-guided
fine-needle aspiration between with and
without the needle stylet using with the
22 gauge fine-needle aspiration needle
Acronym Comparative crossover trial of EUS-FNA with
and without stylet
Scientific Title A multicenter prospective comparative crossover
trial of endoscopic ultrasound-guided
fine-needle aspiration between with and
without the needle stylet using with the
22 gauge fine-needle aspiration needle
Scientific Title:Acronym Comparative crossover trial of EUS-FNA with
and without stylet
Region
Japan

Condition
Condition Pancreatic solid masses detected by imaging examination
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate histological tissue acquisition rate, quality of tissue, accuracy between EUS-FNA with and without stylet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Accuracy
Key secondary outcomes Cellularity of tissue obtained
Quality of tissue obtained
Adequate quality

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 At first and third aspiration,EUSFNA
with stylet is
performed. At second and forth
aspiration, EUS-FNA without stylet is performed.
Interventions/Control_2 At first and third aspiration,EUSFNA
without stylet is performed. At second
and forth aspiration, EUS-FNA with stylet is performed.
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) Patients with solid pancreatic mass,
which can be punctured from stomach
or duodenum using 22G safely.
2) Patients consent to be included in the
study based on his/her own free will
after sufficient informing and
understanding of the study.
Key exclusion criteria 1) Cases in Perfomance status 4
2)Cases with sever complication in
other organs except original disease
(ASA classification more than 3)
3)Cases having impossibility of
cessation of anticoagulant
4)Cases with pregnancy or suspect of
pregnancy
5)Cases having difficulty in endoscopic
approach
6)Cases with definite diagnosis by
another biopsy
7) Cases having difficulty in
visualization of mass on EUS
8)Cases judged by principal investigator
to be inadequate as subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Email itoitakao@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shuntaro Mukai
Organization Tokyo Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL
Email maezora1031@yahoo.co.jp

Sponsor
Institute Tokyo Medical University
Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center Hospital
Endoscopy division
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 20 Day
Last follow-up date
2017 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 20 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021254

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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