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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025704
Receipt No. R000029573
Scientific Title The efficacy of endoscopic ultrasonography using lubricating jelly for examining papilla of Vater
Date of disclosure of the study information 2017/01/17
Last modified on 2017/01/16

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Basic information
Public title The efficacy of endoscopic ultrasonography using lubricating jelly for examining papilla of Vater
Acronym The efficacy of endoscopic ultrasonography using lubricating jelly for examining papilla of Vater
Scientific Title The efficacy of endoscopic ultrasonography using lubricating jelly for examining papilla of Vater
Scientific Title:Acronym The efficacy of endoscopic ultrasonography using lubricating jelly for examining papilla of Vater
Region
Japan

Condition
Condition tumor of the papilla of Vater
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy of endoscopic ultrasonography using lubricating jelly for diagnosing tumors of the papilla of Vater
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sharpness for layers of the ampulla of Vater: conventional method vs lubricating jelly using method
Key secondary outcomes 1. Sharpness for tumor margin and involvement, common bile duct ,and pancreatic duct
2. Procedure time
3. Administration of spasmolytic drugs
4. Total dose of intravenous anesthetics
5. Total dose of analgesics
6. Complications
7. Comparison between endosonographic imaging and pathological diagnosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Conventional method
Interventions/Control_2 Lubricating jelly using method
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are suspected of a tumor of the papilla of Vater and have indication for endosonography and give a written concent for this study.
2. Patients with pancreatobiliary disease who have indication for endosonography and give a written concent for this study.
Key exclusion criteria 1. Patients without consent.
2. Patients who were judged incompatible by attending doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromasa Ohira
Organization Fukushima medical unversity, School of Medicine
Division name Gastroenterology
Zip code
Address 1 Hikarigaoka, Fukushima
TEL 024-547-1202
Email intermed2@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Konno Naoki
Organization Fukushima medical unversity, School of Medicine
Division name Gastroenterology
Zip code
Address 1 Hikarigaoka, Fukushima
TEL 024-547-1202
Homepage URL
Email naoking@fmu.ac.jp

Sponsor
Institute Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, Fukushima Medical University, School of Medicine
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 17 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029573

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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