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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011590
Receipt No. 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

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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
Email 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
Email kin_toshifumi@yahoo.co.jp

Sponsor
Institute Teine-Keijinkai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013549

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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