UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025738 |
|---|---|
| Receipt number | R000029614 |
| Scientific Title | Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass: A prospective study |
| Date of disclosure of the study information | 2017/01/19 |
| Last modified on | 2018/08/02 10:22:08 |
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Basic information
Public title
Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass:
A prospective study
Acronym
ProCore Study for Pancreatic Mass
Scientific Title
Safety and efficacy of endoscopic ultrasound guided fine needle aspiration with core biopsy needle for pancreatic mass:
A prospective study
Scientific Title:Acronym
ProCore Study for Pancreatic Mass
Region
| Japan |
Condition
Condition
Pancreatic Mass
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the novel FNB needle with forward bevel
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accurate histological diagnosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with a solid pancreatic mass larger than 15 mm which required EUS-FNA for pathological confirmation
Key exclusion criteria
(1) difficulty in endoscopic approach due to prior gastroduodenal surgery, (2) daily use of anti-coagulant medicine, (3) platelet count of less than 50,000mm3, (4) PT-INR of more than 1.5.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Sasahira |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Gastroenterology
Zip code
Address
3-8-31, Ariake, Koto-Ku, Tokyo
TEL
03-3520-0111
naoki.sasahira@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Kanata |
Organization
The Cancer Institute Hospital of JFCR
Division name
Department of Gastroenterology
Zip code
Address
3-8-31, Ariake, Koto-Ku, Tokyo
TEL
03-3520-0111
Homepage URL
ryo.kanata@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Self
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
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
| 2017 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
NON
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029614
