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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024508
Receipt No. R000025836
Scientific Title High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study
Date of disclosure of the study information 2016/10/20
Last modified on 2019/07/26

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Basic information
Public title High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study
Acronym High and normal negative pressure for EUS-FNA using the 20-gauge side-port fine-needle in pancreatic solid masses: A multicenter prospective randomized controlled study
Scientific Title High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study
Scientific Title:Acronym High and normal negative pressure for EUS-FNA using the 20-gauge side-port fine-needle in pancreatic solid masses: A multicenter prospective randomized controlled study
Region
Japan

Condition
Condition pancreatic solid mass
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of EUS-FNA on pancreatic solid masses using 20-gauge needles with side-port and high negative pressure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acquisition rate of tissue sample adequate for histological diagnosis
Key secondary outcomes Acquisition rate of white tissue sample, accuracy of pathological diagnosis, size of the sample, adequacy for immunohistochemistry, quality of the sample, adequacy for cytologic diagnosis, and adverse events regarding puncturing site.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Negative pressure for EUS-FNA (10mL)
Interventions/Control_2 Negative pressure for EUS-FNA (50mL)
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) Diagnosed as pancreatic solid mass
2) Mass size of larger than 20mm
3) Age older than 20
4)Informed consent provided the patient him/herself
Key exclusion criteria 1) Case of Performance Status 4.
2) Case with severe comorbidity; American Society of Anesthesiologists (ASA) Grade 3-5
3) Can not stop anti-coagulation or anti-platelet agents.
4) Pregnant or suspicious for pregnancy.
5) Difficulty with endoscopic approach due to post operative state.
6) Case with pathologically confirmation.
7) Gastrointestinal obstruction.
8) Platelet count less than 50,000/mm3
9) PT-INR more than 2.0
10) Those inadequate for endoscopy.
11) Those judged inappropriate by the doctors in charge.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kawakami
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code 889-1692
Address 5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL 0985-85-9797
Email hiropon@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Yoshimasa
Middle name
Last name Kubota
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code 889-1692
Address 5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL 0985-85-9797
Homepage URL
Email y_kubota@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
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 Clinical Research Support Center, University of Miyazaki
Address 5200 Kihara, Kiyotake, Miyazaki city, Miyazaki
Tel 0985-85-1510
Email rinken@med.miyazaki-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

Other administrative information
Date of disclosure of the study information
2016 Year 10 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
2016 Year 06 Month 30 Day
Date of IRB
2016 Year 07 Month 19 Day
Anticipated trial start date
2016 Year 07 Month 16 Day
Last follow-up date
2018 Year 08 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 20 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025836

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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