UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005939 |
|---|---|
| Receipt number | 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 18:29:43 |
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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
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
takudou1980@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006908
