UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016311 |
|---|---|
| Receipt number | R000018934 |
| Scientific Title | A feasibility study to evaluate the efficacy and safety of endoscopic ultrasound-guided through-the-needle pancreatic cyst wall biopsy |
| Date of disclosure of the study information | 2015/01/26 |
| Last modified on | 2021/01/29 11:15:56 |
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Basic information
Public title
A feasibility study to evaluate the efficacy and safety of endoscopic ultrasound-guided through-the-needle pancreatic cyst wall biopsy
Acronym
A feasibility study of EUS-TNPCB
Scientific Title
A feasibility study to evaluate the efficacy and safety of endoscopic ultrasound-guided through-the-needle pancreatic cyst wall biopsy
Scientific Title:Acronym
A feasibility study of EUS-TNPCB
Region
| Japan |
Condition
Condition
Pancreatic cystic neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy and safety of EUS-guided through-the-needle pancreatic cyst wall biopsy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An adequacy rate of tissue sampling
Key secondary outcomes
Histopathological diagnosis
A rate of adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-guided through-the-needle pancreatic cyst wall biopsy
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
Pancreatic cystic neoplasms
Key exclusion criteria
1, Performance status 2 or more
2, ASA classification 3 or more
3, Coagulopathy
4, Contraindication for upper endoscopy
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
011-706-7715
kkawakubo-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumichi Kawakubo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo
TEL
011-706-7715
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018934
