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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035905
Receipt No. R000039650
Scientific Title Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA.
Date of disclosure of the study information 2019/02/18
Last modified on 2019/03/20

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Basic information
Public title Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA.
Acronym Effect of number of strokes within targeted lesion during EUS-FNA
Scientific Title Randomized controled trial of effect of number of strokes within targeted lesion during EUS-FNA.
Scientific Title:Acronym Effect of number of strokes within targeted lesion during EUS-FNA
Region
Japan

Condition
Condition pancreatic lesions which require histological diagnosis by EUS-FNA
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of number of strokes within targeted lesion on quality of histological specimens obtaned by EUS-FNA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase III

Assessment
Primary outcomes Histological quality and quantity in macroscopic whitish specimen.
Key secondary outcomes Histological quality and quantity in macroscopic reddish specimen.
Cytological quality and quantity
Success rate of EUS-FNA procedure
Adverse events
Diagnostic accuracy of EUS-FNA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 30 times of stroke of needle within targeted lesion
Interventions/Control_2 10 times of stroke of needle within targeted lesion
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. Lesion that require histological interpretation to obtain defenitive diagnosis
2. Age >=20 y
3. Ability to understand and willingness to sign a written statement of informed consent
Key exclusion criteria 1. Cystic lesion without solid component which can be punctured by EUS-FNA procedure
2. Difficult to visualize targeted lesion due to surgically altered anatomy etc.
3. Bleedinfg tendency
4. ASA >=3
5. ECOG PS >=4
6. Severe heart or plumonary disease
7. Pregnant or possibly pregnant women
8. Any disorder that compromised the patient's ability to provide written informed consent and/or comply with the study procedure
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Teine Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL 011-681-8111
Email thayashi244@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Teine Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL 011-681-8111
Homepage URL
Email thayashi244@gmail.com

Sponsor
Institute Center for Gastroenterology, Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization Center for Gastroenterology, Teine Keijinkai 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
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1 00
Org. issuing International ID_1 Teine Keijinkai Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 18 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 Terminated
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 01 Month 15 Day
Anticipated trial start date
2019 Year 02 Month 18 Day
Last follow-up date
2019 Year 02 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039650

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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