UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004119 |
|---|---|
| Receipt number | R000004952 |
| Scientific Title | Efficacy and safety of single-session endscopic ultrasonograpy guided fine needle aspiration biopsy and endscopic retrograde cholangiopancreatography for pathological diagnosis of pancreatic mass lesion. |
| Date of disclosure of the study information | 2010/08/31 |
| Last modified on | 2010/08/27 22:58:29 |
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Basic information
Public title
Efficacy and safety of single-session endscopic ultrasonograpy guided fine needle aspiration biopsy and endscopic retrograde cholangiopancreatography for pathological diagnosis of pancreatic mass lesion.
Acronym
Efficacy and safety of single-session EUS-FNAB and ERCP for pathological diagnosis of pancreatic mass lesion.
Scientific Title
Efficacy and safety of single-session endscopic ultrasonograpy guided fine needle aspiration biopsy and endscopic retrograde cholangiopancreatography for pathological diagnosis of pancreatic mass lesion.
Scientific Title:Acronym
Efficacy and safety of single-session EUS-FNAB and ERCP for pathological diagnosis of pancreatic mass lesion.
Region
| Japan |
Condition
Condition
pancreatic mass lesion
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We prospectively evaluated the efficacy and safety of single-session EUS-FNA and ERCP. Accomplishment rate of procedure, time of procedure, and complication rate are evaluated.
We also study risk factors of single session EUS-FNAB and ERCP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accomplishment rate of procedure within 70 minutes
Key secondary outcomes
Accomplishment rate of procedure
Total time of procedure
Complication rate
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
Single-session EUS-FNAB and ERCP is performed for sampling of pathological material to the patients with pancreatic mass lesion.
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
The study is designed to enroll the patients with suspicious pancreatic mass lesion on CT or US.
Key exclusion criteria
The exclusion criteria are as follows:
Karnofsky Performance Status <50%, active infection, the patient with inaccessible papilla Vater due to altered anatomy, Bleeding tendency(platelets<50000/mm3, prothrombin time<50%), severe complication such as liver cirrhosis and heart disease, active concomitant malignancy, and the patient inappropriate for entry onto this study under the judgment of the investigator.
Written informed consent is required from all patients.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawamoto |
Organization
Okayama University Hospital
Division name
Departments of Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
086-223-7151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawamoto |
Organization
Okayama University Hospital
Division name
Departments of Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
086-223-7151
Homepage URL
h-kawamo@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
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
岡山大学病院（岡山県）、倉敷中央病院（岡山県）、広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 27 | Day |
Last modified on
| 2010 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004952
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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