UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042402 |
|---|---|
| Receipt number | R000048402 |
| Scientific Title | Long-term outcome of Endoscopic gallbladder stenting |
| Date of disclosure of the study information | 2020/11/16 |
| Last modified on | 2020/11/09 23:42:39 |
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Basic information
Public title
Endoscopic gallbladder stenting versus removal of gallbladder drainage, long-term outcome in management of acute cholecystitis in surgical high-risk patients for cholecystectomy
Acronym
Long-term outcome of Endoscopic gallbladder stenting
Scientific Title
Long-term outcome of Endoscopic gallbladder stenting
Scientific Title:Acronym
Long-term outcome of Endoscopic gallbladder stenting
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the long-term outcome of long-term EGBS and removal of gallbladder drainage after PTGBD or ETGBD for acute cholecystitis in surgical high-risk patients and to clarify the usefulness of long-term EGBS.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To compare the long-term outcome between the EGBS and PT/ENGBD group.
Key secondary outcomes
Comparison of the technical success rate, clinical success rate, and early AE rate between the ETGBD and PTGBD.
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
| 36 | years-old | <= |
Age-upper limit
| 97 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were considered as surgical high-risk patients and underwent either ETGBD or PTGBD for acute cholecystitis.
Key exclusion criteria
Prior history of upper gastrointestinal or biliary tract surgery, except for gastrectomy with Billroth I reconstruction; presence of pancreatobiliary malignancies; presence of bile duct stricture, including primary sclerosing cholangitis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Maruta |
Organization
Gifu prefectural general medical center
Division name
Department of Gastroenterology
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City
TEL
058-246-1111
mrak5844@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Maruta |
Organization
Gifu prefectural general medical center
Division name
Department of Gastroenterology
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City
TEL
058-246-1111
Homepage URL
mrak5844@yahoo.co.jp
Sponsor or person
Institute
Gifu prefectural general 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
Gifu prefectural general medical center
Address
4-6-1 Noisshiki, Gifu City
Tel
058-246-1111
chiken-center.4289@gifu-hp.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
| 2020 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
180
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective cohort study conducted at three tertiary care centers: Gifu Prefectural General Medical Center, Gifu University Hospital, and Gifu Municipal Hospital. The database used for this study included clinical data of all ERCP and PTGBD procedures performed at these three institutions between January 2010 and December 2018.Inclusion criteria were patients who were considered as surgical high-risk patients and underwent either ETGBD or PTGBD for acute cholecystitis.
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048402
