UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002052 |
|---|---|
| Receipt number | R000002499 |
| Scientific Title | Clinical trial for effectiveness and safety of percutaneous transhepatic gallbladder aspiration in patients with acute cholecystitis |
| Date of disclosure of the study information | 2009/06/10 |
| Last modified on | 2012/12/10 08:20:09 |
* 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
Clinical trial for effectiveness and safety of percutaneous transhepatic gallbladder aspiration in patients with acute cholecystitis
Acronym
PTGBA for acute cholecystitis
Scientific Title
Clinical trial for effectiveness and safety of percutaneous transhepatic gallbladder aspiration in patients with acute cholecystitis
Scientific Title:Acronym
PTGBA 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
The aim of this clinical trial is to evaluate effectiveness and safety of percutaneous transhepatic gallbladder aspiration for acute cholecystitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of right hypochondralgia at the 24-hour and/or 72-hour treatment
Key secondary outcomes
treatment period
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
percutaneous transhepatic gallbladder aspiration
Interventions/Control_2
conservative therapy
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
Patients with mild acute cholecystitis, which is defined by "Tokyo Guidelines for the management of acute cholangitis and cholecystitis"
Key exclusion criteria
1) Patients with choledocholithiasis
2) Patients with acalculous cholecystitis
3) Patients with moderate or severe cholecystitis
4) Patients whom symptoms are improving
5) Patients with serious complications
6) Patients with other infectious disease
7) Patients with suspected gallbladder cancer
8) Patients with the bleeding tendency
9) Patients receiving anticoagulants
10) Patients with previous history of antibiotic hypersensitivity
11) Patients with the pregnancy or the pregnant likelihood
12) Inappropriate patients for entry on this study by the judgment of the investigators
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio TSUYUGUCHI |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
TEL
043-222-7171
Homepage URL
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Chiba University
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 10 | 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
| 2007 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 07 | Day |
Last modified on
| 2012 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002499
