UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050028 |
|---|---|
| Receipt number | R000056993 |
| Scientific Title | Endoscopic cutting internalization versus removal of the endoscopic transpapillary nasogallbladder drainage tube in preoperative management of acute cholecystitis: a retrospective multicenter cohort study |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/13 14:44:37 |
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Basic information
Public title
Endoscopic cutting internalization versus removal of the endoscopic transpapillary nasogallbladder drainage tube in preoperative management of acute cholecystitis: a retrospective multicenter cohort study
Acronym
Endoscopic cutting internalization versus removal of the endoscopic transpapillary nasogallbladder drainage tube
Scientific Title
Endoscopic cutting internalization versus removal of the endoscopic transpapillary nasogallbladder drainage tube in preoperative management of acute cholecystitis: a retrospective multicenter cohort study
Scientific Title:Acronym
Endoscopic cutting internalization versus removal of the endoscopic transpapillary nasogallbladder drainage tube
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 late adverse event, such as recurrence rate of cholecystitis, between the converting from ENGBD to EGBS and removing ENGBD after improvement of cholecystitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the late adverse events while waiting for elective cholecystectomy between the Cutting and the Removal groups.
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
1) Patient who underwent ENGBD for management of acute cholecystitis
2) Patient who underwent elective cholecystectomy.
Key exclusion criteria
1) direct cholecystectomy with in-situ ENGBD
2) prior history of upper gastrointestinal or biliary tract surgery, except for gastrectomy with Billroth I reconstruction
3) presence of upper gastrointestinal or pancreatobiliary malignancies
4) presence of bile duct stricture, including primary sclerosing cholangitis.
Target sample size
70
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, Gifu Prefecture
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, Gifu Prefecture
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
Gifu Prefectural General Medical Center
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, Gifu Prefecture
Tel
058-246-1111
mrak5844@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
| 2023 | Year | 02 | Month | 01 | 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
96
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
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was closed because it was a retrospective observational study.
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056993
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
