UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015349 |
|---|---|
| Receipt number | R000017855 |
| Scientific Title | Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study |
| Date of disclosure of the study information | 2014/10/06 |
| Last modified on | 2015/11/10 11:32:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study
Acronym
Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis
Scientific Title
Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis: a prospective feasibility study
Scientific Title:Acronym
Endoscopic transpapillary gallbladder drainage using microguidewire for acute cholecystitis
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Endoscopic transpapillary gallbladder drainage using microguidewire
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate, Clinical success rate
Key secondary outcomes
Complications
Increase rate of technical success rate by using microguidewire
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic transpapillary gallbladder drainage
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
1)Patients in whom gallbladder drainage are needed
2)Age >20
3)Written informed consent was obtained.
Key exclusion criteria
1)Cases having difficulty in endoscopic approach
2)Cases with sever complication in other organs
3)Cases without informed consent
4)Cases judged by principal investigator to be inadequate as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Hayashi |
Organization
Ichinomiya Nishi hospital
Division name
Division of Gastroenterology
Zip code
Address
Kaimei Hira 1, Ichinomiya, Aichi, Japan
TEL
0586-48-0077
sntr.hayashi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Hayashi |
Organization
Ichinomiya Nishi hospital
Division name
Division of Gastroenterology
Zip code
Address
Kaimei Hira 1, Ichinomiya, Aichi, Japan
TEL
0586-48-0077
Homepage URL
sntr.hayashi@gmail.com
Sponsor or person
Institute
Ichinomiya Nishi hospital
Institute
Department
Personal name
Funding Source
Organization
Ichinomiya Nishi 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
一宮西病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017855
