UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025704 |
|---|---|
| Receipt number | 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 | 2024/02/20 09:20:39 |
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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 | Hiromasa |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima medical unversity, School of Medicine
Division name
Gastroenterology
Zip code
960-1247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1202
intermed2@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Konno |
Organization
Fukushima medical unversity, School of Medicine
Division name
Gastroenterology
Zip code
960-1247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1202
Homepage URL
naoking@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukushima Medical University, School of Medicine
Institute
Department
Personal name
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima
Tel
024-547-1202
naoking@fmu.ac.jp
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
0
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
| 2017 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 20 | Day |
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
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
