UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022268 |
|---|---|
| Receipt number | R000025659 |
| Scientific Title | Clinical study about the utility of the ENPD catheter for pancreatic juice cytology |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/01/30 17:18:35 |
* 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
Clinical study about the utility of the ENPD catheter for pancreatic juice cytology
Acronym
Clinical study about the utility of the ENPD catheter for pancreatic juice cytology
Scientific Title
Clinical study about the utility of the ENPD catheter for pancreatic juice cytology
Scientific Title:Acronym
Clinical study about the utility of the ENPD catheter for pancreatic juice cytology
Region
| Japan |
Condition
Condition
pacreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The searching non-blind study non-controlled trial which considers the accuracy and safety of the pancreatic juice cytology using an ENPD catheter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of the pancreatic juice cytology using an ENPD catheter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Custody of 5FrENPD catheter
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The age of the time of the agreement merit is more than 20-year-old inpatient.
(2) The patient pancreatic cancer is doubted as a result of the diagnostic imaging and who needs implementation of ERCP
(3) The patient who can get consent by a document about participation of this research
Key exclusion criteria
(1) The patient who has that the acute stage of the acute pancreatitis.
(2) Patient with the past of a big surgery-like operation in the liver,the gallbladder,and the pancreas
(3) Patient with the past of a gastric resection.
(4) The patient who can think unresectable pancreatic cancer in diagnostic imaging.
(5) The patient who admits many viscous liquid in the pancreatic duct and suspects IPMN (Intraductal Papillary Mucinous Neoplasm) clinically.
(6) The patient for whom it's difficult to receive informed consent
(7) Patient with the past which manifested the allergic reaction by the medicine used in case of usual ERCP (pancreatic enzyme inhibitor/antibiotic/downer/antispastic/painkiller/contrast medium) and a polyurethane product.
(8) Additionally the patient who judged that a study doctor in attendance was unsuitable for registration of this research(pregnant woman).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Serikawa |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5192
serikawa@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Shimizu |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5192
Homepage URL
suiken@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital
Department of Gastroenterology and Metabolism
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
| 2016 | Year | 06 | Month | 01 | 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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025659
