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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012127
Receipt No. R000014182
Scientific Title Aspiration Method of Endoscopic Ultrasound-Guided Fine-needle Aspiration for Solid Pancreatic Mass. -The Prospective Cross Over Trial of EUS-FNA Using 22G Aspiration with Conventional Method or Knocking The Door Method for Solid Pancreatic Mass, Multicenter Clinical Study-
Date of disclosure of the study information 2013/10/26
Last modified on 2015/04/25

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Basic information
Public title Aspiration Method of Endoscopic Ultrasound-Guided Fine-needle Aspiration for Solid Pancreatic Mass.
-The Prospective Cross Over Trial of EUS-FNA Using 22G Aspiration with Conventional Method or Knocking The Door Method for Solid Pancreatic Mass, Multicenter Clinical Study-
Acronym The Prospective Cross Over Trial of EUS-FNA Using 22G Aspiration with Conventional Method or Knocking The Door Method, Multicenter Clinical Study.
Scientific Title Aspiration Method of Endoscopic Ultrasound-Guided Fine-needle Aspiration for Solid Pancreatic Mass.
-The Prospective Cross Over Trial of EUS-FNA Using 22G Aspiration with Conventional Method or Knocking The Door Method for Solid Pancreatic Mass, Multicenter Clinical Study-
Scientific Title:Acronym The Prospective Cross Over Trial of EUS-FNA Using 22G Aspiration with Conventional Method or Knocking The Door Method, Multicenter Clinical Study.
Region
Japan

Condition
Condition Solid pancreatic mass
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness of EUS-FNA with knocking door method for solid pancreatic mass.
Primary evaluation: accuracy rate
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Accuracy rate
Key secondary outcomes Quality of tissue specimen
Complications

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 Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 At first and third aspiration,EUS-FNA using conventional method is performed. At second and forth aspiration, EUS-FNA using knocking door method is performed.
Interventions/Control_2 At first and third aspiration,EUS-FNA using knocking the door method is performed. At second and forth aspiration, EUS-FNA using conventional method is performed.
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) Patients with solid pancreatic mass, which can be punctured from stomach or duodenum using 22G safely.
2) Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria 1) Cases in Perfomance status 4
2)Cases with sever complication in other organs except original disease (ASA classification more than 3)
3)Cases having impossibility of cessation of anticoagulant
4)Cases with pregnancy or suspect of pregnancy
5)Cases having difficulty in endoscopic approach
6)Cases with definite diagnosis by another biopsy
7) Cases having difficulty in visualization of mass on EUS
8)Cases judged by principal investigator to be inadequate as subjects
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University
Division name Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Email itoitakao@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shuntaro Mukai
Organization Tokyo Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL
Email d-somu@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Aizu medical center fukushima medical university
Osaka medical center for cancer and cardiovascular diseases
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 26 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 Completed
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 01 Day
Date analysis concluded
2015 Year 04 Month 20 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 25 Day
Last modified on
2015 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014182

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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