UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012127 |
|---|---|
| Receipt number | 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 22:59:59 |
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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
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
d-somu@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014182
