UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022987 |
|---|---|
| Receipt number | R000026496 |
| Scientific Title | Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy |
| Date of disclosure of the study information | 2016/07/02 |
| Last modified on | 2020/07/06 07:34:52 |
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Basic information
Public title
Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy
Acronym
Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy
Scientific Title
Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy
Scientific Title:Acronym
Multicenter prospective study on the efficacy and safety of PTGBA in acute cholecystitis on anti-thrombotic therapy
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 PTGBA for acute cholecystitis in patients with anti-thrombotic therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Procedure success rate
Safty
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
PTGBA
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 with anti-thrombotic therapy
2) Moderate or severe acute cholecystitis
3) There is no recommend of emergency surgery
4) age =>20
Key exclusion criteria
1) No informed concent
2) Patients with mild cholecystitis
3) Patients with perforation of the gallbladder
4) Patients with pericholecystic abscess
5) Patients with gallbladder cancer
6) Patients with cholangitis
7) Ascitic fluid
8) Pregnancy
9) Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University school of medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kitasato University
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel
+81-42-778-7756
rinri@med.kitasato-u.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
| 2016 | Year | 07 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026496
