UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011590 |
|---|---|
| Receipt number | R000013549 |
| Scientific Title | A prospective study of diagnostic accuracy of EUS-FNA for pancreatic solid lesion with conventional needle using slow pull technique |
| Date of disclosure of the study information | 2013/08/27 |
| Last modified on | 2020/04/14 10:59:06 |
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Basic information
Public title
A prospective study of diagnostic accuracy of EUS-FNA
for pancreatic solid lesion with conventional needle using slow pull technique
Acronym
SP study
Scientific Title
A prospective study of diagnostic accuracy of EUS-FNA
for pancreatic solid lesion with conventional needle using slow pull technique
Scientific Title:Acronym
SP study
Region
| Japan |
Condition
Condition
pancreatic solid lesion
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of EUS-FNA
for pancreatic solid lesion with conventional needle using slow pull technique
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the diagnostic accuracy of EUS-FNA using slow pull technique
Key secondary outcomes
the diagnostic accuracy of each needle pass
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-FNA using slow pull technique
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pancreatic solid lesions confirmed by imaging modalities
Key exclusion criteria
Presence of severe comorbidities, coagulopathy
Inability to detect pancreatic solid lesion by EUS
Inability to obtain informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kin |
| Middle name | |
| Last name | Toshifumi |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-jo 12-chome, Maeda, Tiene-ku, Sapporo
TEL
011-681-8111
kin_toshifumi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kin |
| Middle name | |
| Last name | Toshifumi |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-jo 12-chome, Maeda, Tiene-ku, Sapporo
TEL
011-681-8111
Homepage URL
kin_toshifumi@yahoo.co.jp
Sponsor or person
Institute
Teine-Keijinkai 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
Teine-Keijinkai Hospital
Address
1-jo 12-chome, Maeda, Tiene-ku, Sapporo
Tel
011-681-8111
teine@keijinkai.or.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
| 2013 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
40
Results
The diagnostic accuracy of SP-FNA was 90% (36/40). There was no significant difference in the accuracy between SP-FNA and SA-FNA (90% vs. 90%, p = 1.000). The samples obtained using SP-FNA were assessed as Grade 2 for quantity in 29 cases (73%), quality in 31 (78%), and blood contamination in 25 (63%).
Results date posted
| 2020 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with a pancreatic solid lesion
Participant flow
prospectively enrolled
Adverse events
Not observed
Outcome measures
diagnostic accuracy, quantity, quality, and blood contamination level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013549
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
