UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025738
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ryo.kanata@jfcr.or.jp

Sponsor
Institute Japanese Foundation for Cancer Research
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.