UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029122 |
|---|---|
| Receipt number | R000033303 |
| Scientific Title | Short-term and long-term results of endoscopic treatment for pancreatic stones with a novel basket catheter : a prospective study |
| Date of disclosure of the study information | 2017/09/13 |
| Last modified on | 2017/09/13 01:16:45 |
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Basic information
Public title
Short-term and long-term results of endoscopic treatment for pancreatic stones with a novel basket catheter : a prospective study
Acronym
Efficacy of endoscopic therapy for pancreatic stones with a novel basket catheter
Scientific Title
Short-term and long-term results of endoscopic treatment for pancreatic stones with a novel basket catheter : a prospective study
Scientific Title:Acronym
Efficacy of endoscopic therapy for pancreatic stones with a novel basket catheter
Region
| Japan |
Condition
Condition
Chronic pancreatitis with pancreatic stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of endoscopic treatment for pancreatic stones with a novel basket catheter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
short-term and long-term results of endoscopic treatment for pancreatic stones with a novel basket catheter
Key secondary outcomes
Safety of a novel basket catheter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic stone removal with basket catheter
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
･Patietns with main pancreatic duct dilatations due to pancreatic stones
･Patients with intractable abdominal pain
Key exclusion criteria
･Patients with pancreatic pseudocyst
･Patients who had preveously undergone surgery
･Patients with malignant disease
･Patients without written informed consent
･Patients considered ineligible for this study
Target sample size
202
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rintaro Mikata |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2083
rinta48@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ohyama |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2083
Homepage URL
ooyama-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 13 | 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 | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 13 | 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 | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033303
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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