UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047977 |
|---|---|
| Receipt number | R000054696 |
| Scientific Title | Safety and efficacy of emergent endoscopic transpapillary gallbladder drainage complemented by endoscopic ultrasound guided gallbladder drainage |
| Date of disclosure of the study information | 2022/06/07 |
| Last modified on | 2022/06/07 16:12:06 |
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Basic information
Public title
Safety and efficacy of emergent endoscopic transpapillary gallbladder drainage complemented by endoscopic ultrasound guided gallbladder drainage
Acronym
Safety and efficacy of emergent ETGBD complemented by EUS-GBD
Scientific Title
Safety and efficacy of emergent endoscopic transpapillary gallbladder drainage complemented by endoscopic ultrasound guided gallbladder drainage
Scientific Title:Acronym
Safety and efficacy of emergent ETGBD complemented by EUS-GBD
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ETGBD complemented by EUS-GBD in the same session comparing to traditional ETGBD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success rate
Clinical success rate
Procedure related adverse event rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Moderate/severe acute cholecystitis patients with high-risk of surgery/PTGBD, due to high age, continuous antithrombotic therapies, severe comorbidities and physical conditions.
Consecutive patients underwent traditional ETGBD (T-ETGBD) and a new drainage strategy; ETGBD complemented by EUS-GBD (C-ETGBD) for emergent initial gallbladder drainage.
Key exclusion criteria
Patients who underwent initial gallbladder drainage by other than ETGBD, and patients who underwent prior gallbladder drainage
Patients with cholecystitis accompanied by choledocholithiasis were also excluded, since most cholecystitis caused by choledocholithiasis improve after common bile duct treatment.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213 Ichi, Oita, Japan
TEL
0975411311
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213 Ichi, Oita, Japan
TEL
0975411311
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita San-ai Medical Center
Address
1213 Ichi, Oita, Japan
Tel
0975411311
sagami1985@yahoo.co.jp
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
| 2022 | Year | 06 | Month | 07 | 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
| 2021 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054696
