UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006512 |
|---|---|
| Receipt number | R000007706 |
| Scientific Title | Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: a prospective feasibility study |
| Date of disclosure of the study information | 2011/10/10 |
| Last modified on | 2017/06/10 10:21:10 |
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Basic information
Public title
Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: a prospective feasibility study
Acronym
EUS-GBD for acute cholecystitis
Scientific Title
Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: a prospective feasibility study
Scientific Title:Acronym
EUS-GBD for acute cholecystitis
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of EUS-GBD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate, Clinical success rate
Key secondary outcomes
Complications
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 ultrasound-guided 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)Acute cholecystitis
2)Moderate or mild cholecystitis which was not relieved with conservative therapy.
3)Performance Status 0-3.
4)Age >20
5)Written informed consent was obtained.
Key exclusion criteria
1)Severe cholecystitis
2)Cholangititis with choledocholithiasis
3)Post-gastrectomy(B-II or Roux-en-Y anastomosis)
4)Cardiovascular or respiratory decompensation
5)Severe renal dysfunction
6)With steroid therapy
7)Severe ascites
8)Severe bleeding diathesis
9)JCS >1-1
10)Severe heart disease
11)Severe pulmonary disease
12)Pregnant womman
13)Inappropriate patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
kkawakubo-gi@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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
| 2011 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007706
