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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002052
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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