UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000005939
Receipt No. R000006908
Scientific Title Endoscopic ultrasound-guided fine-needle aspiration(EUS-FNA) of a pancreatic solid mass using a 25-gauge fine-needle aspiration needle - normal negative pressure versus high negative pressure: A multicenter, prospective randomized controlled trial
Date of disclosure of the study information 2011/07/07
Last modified on 2020/01/10 (Ver. 7)

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Basic information
Public title Endoscopic ultrasound-guided fine-needle aspiration(EUS-FNA) of a pancreatic solid mass using a 25-gauge fine-needle aspiration needle - normal negative pressure versus high negative pressure: A multicenter, prospective randomized controlled trial
Acronym EUS-FNA: normal versus high negative pressure.
Scientific Title Endoscopic ultrasound-guided fine-needle aspiration(EUS-FNA) of a pancreatic solid mass using a 25-gauge fine-needle aspiration needle - normal negative pressure versus high negative pressure: A multicenter, prospective randomized controlled trial
Scientific Title:Acronym EUS-FNA: normal versus high negative pressure.
Region
Japan

Condition
Condition Pancreatic tumor detected by imaging study
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether high negative suction pressure could improve the rate of acquisition of specimen materials of pancreatic tumor detected by imaging study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The rate of acquisition of the histological specimen and the accuracy of pathological diagnosis
Key secondary outcomes The quantity and quality of specimen material, cytological diagnostic performance, and complication

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 High negative suction pressure
Interventions/Control_2 Normal negative suction pressure
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 Pancreatic tumor detected by imaging study
Key exclusion criteria <20years old
Enforcement of EUS-FNA is inappropriate.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kawakami
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 060-8648
Address North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-716-1161
Email takudou1980@yahoo.co.jp

Public contact
Name of contact person
1st name Taiki
Middle name
Last name Kudo
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 060-8648
Address North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-716-1161
Homepage URL
Email takudou1980@yahoo.co.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
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 Hokkaido University Graduate School of Medicine
Address North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
Tel 011-716-2111
Email takudou1980@yahoo.co.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
2011 Year 07 Month 07 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/24890422
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/24890422
Number of participants that the trial has enrolled 90
Results 
Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition
Results date posted
2020 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
patients with solid pancreatic masses, as 
detected by ultrasound, computed tomography, or magnetic resonance imaging
Participant flow 
patients with solid pancreatic masses, as 
detected by ultrasound, computed tomography, or magnetic resonance imaging
Adverse events 
none
Outcome measures 
to determine the adequacy of tissue 
acquisition by the EUS-FNA/HNP combined technique and to determine the accuracy 
of histological diagnoses achievable using this technique.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 09 Day
Date of IRB
2011 Year 05 Month 01 Day
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 11 Month 01 Day
Date analysis concluded
2012 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 06 Day
Last modified on
2020 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006908