UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031722 |
|---|---|
| Receipt number | R000036218 |
| Scientific Title | Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial. |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2019/03/13 15:14:37 |
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Basic information
Public title
Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.
Acronym
Comparative study of endoscopic therapy for acute cholecystitis
Scientific Title
Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.
Scientific Title:Acronym
Comparative study of endoscopic therapy for acute cholecystitis
Region
| Japan |
Condition
Condition
inoperative acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the appropriate treatment for patients with acute cholecystitis who have no indication for emergency surgery via comparison of the efficacy and safety of ERGBD VS EUS-GBD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Efficiency of each treatment
Disappearance of abdominal pain
Normalization of white blood cell count
Half of C-reactive protein value
Key secondary outcomes
Procedure success rate
Treatment time
Complication rate
Recurrence rate of cholecystitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with acute cholecystitis treated by ERGBD.
Interventions/Control_2
Patients with acute cholecystitis treated by EUS-GBD.
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 acute cholecystitis determined emergency drainage is necessary
Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc.
Those who are able to follow the passage of 60 days after treatment.
Key exclusion criteria
Patients with multiple organ dysfunction
Patients with common bile duct stones
Pregnant, Female patient with potential for pregnancy or lactating
Patients who are complicated with psychosis or psychiatric symptoms and seem to be difficult to participate in the study
Patients who are allergic to antibiotics
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
New Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oita San-ai Medical Center
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
| 2018 | Year | 03 | Month | 20 | 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
| 2018 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036218
