UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012308 |
|---|---|
| Receipt number | R000014388 |
| Scientific Title | Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis |
| Date of disclosure of the study information | 2013/11/15 |
| Last modified on | 2022/05/24 17:08:12 |
* 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
Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Acronym
Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Scientific Title
Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Scientific Title:Acronym
Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage 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 endoscopic naso-gallbladder drainage and 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
treatment period
Key secondary outcomes
safety
efficiency
success rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic naso-gallbladder drainage
Interventions/Control_2
percutaneous transhepatic gallbladder aspiration
Interventions/Control_3
percutaneous transhepatic gallbladder drainage
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 necessary of teatment with drainage for 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 mild acute cholecystitis who improved conservative therapy
3) Patients with emphysematous cholecystitis or gallbladder perforation or complicated with biliary peritonitis
4) Inappropriate patients for entry on this study by the judgement of the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi IZUMI |
Organization
Machida Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41 Asahimachi, Machida-shi, Tokyo, Japan
TEL
042-722-2230
y.masui@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Masui |
Organization
Machida Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41 Asahimachi, Machida-shi, Tokyo, Japan
TEL
042-722-2230
Homepage URL
y.masui@machida-city-hp.jp
Sponsor or person
Institute
Machida Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Machida Municipal 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 15 | 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
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014388
