UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045991 |
|---|---|
| Receipt number | R000052500 |
| Scientific Title | Observational study for the usefulness and safety of endoscopic transpapillary gallbladder drainage for acute cholecystitis |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2023/11/15 17:58:08 |
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Basic information
Public title
Observational study for the usefulness and safety of endoscopic transpapillary gallbladder drainage (ETGBD) for acute cholecystitis
Acronym
Observational study for the usefulness and safety of ETGBD for acute cholecystitis
Scientific Title
Observational study for the usefulness and safety of endoscopic transpapillary gallbladder drainage for acute cholecystitis
Scientific Title:Acronym
Observational study for the usefulness and safety of ETGBD for acute cholecystitis
Region
| Japan |
Condition
Condition
acute cholecystitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety between group of one and two gallbladder stent during ETGBD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Presence or absence of difficulty in intubation into the gallbladder
2. Long-term patency rate
3. Presence or absence of complications
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which ETGBD was performed for acute cholecystitis for which surgery was judged to be unsuitable between April 1, 2015 and March 31, 2027.
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7481
takapochi0809@gmail.com
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University
Division name
Department of Gastroenterology and Hepatology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki 852-8501, JAPAN
TEL
095-819-7481
Homepage URL
takapochi0809@gmail.com
Sponsor or person
Institute
Nagasaki University
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken,Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
| 2021 | Year | 11 | Month | 05 | 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 | 11 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052500
