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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004119
Receipt No. 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

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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
Email

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
Email h-kawamo@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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