UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047715 |
|---|---|
| Receipt number | R000054404 |
| Scientific Title | A retrospective study to evaluate a TG18-advocated criterion of diagnosis and operation for patients with acute cholecystitis |
| Date of disclosure of the study information | 2022/05/11 |
| Last modified on | 2025/09/09 17:37:07 |
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Basic information
Public title
A retrospective study to evaluate a TG18-advocated criterion of diagnosis and operation for patients with acute cholecystitis
Acronym
TG18 evaluation study
Scientific Title
A retrospective study to evaluate a TG18-advocated criterion of diagnosis and operation for patients with acute cholecystitis
Scientific Title:Acronym
A retrospective study to evaluate a TG18-advocated criterion of diagnosis and operation for patients with acute cholecystitis
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate TG18 advocate criterion of diagnosis and operation focused on elderly AC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of undiagnosable AC using diagnostic criteria in TG18.
Key secondary outcomes
The rates of unfit for surgery based on ASA-PS and CCI, and clinical consequences at discharge.
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
(1) AC confirmed by clinical course, PTGBD, ETGBD, or Lap-C.
Key exclusion criteria
(1) Other diagnoses confirmed after admission.(2) missing date of valuables of interest.
Target sample size
217
Research contact person
Name of lead principal investigator
| 1st name | Tesshin |
| Middle name | |
| Last name | Ban |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
443-8501
Address
1-1 Mukaida, Hirata, Gamagori, Aichi, 443-8501, Japan
TEL
0533662200
venzosan0204@gmail.com
Public contact
Name of contact person
| 1st name | Tesshin |
| Middle name | |
| Last name | Ban |
Organization
Gamagori City Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
443-8501
Address
1-1 Mukaida, Hirata, Gamagori, Aichi, 443-8501, Japan
TEL
0533662200
Homepage URL
venzosan0204@gmail.com
Sponsor or person
Institute
Gamagori City Hospital
Institute
Department
Personal name
Funding Source
Organization
Gamagori City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gamagori City Hospital
Address
1-1 Mukaida, Hirata, Gamagori, Aichi, 443-8501, Japan
Tel
0533662200
venzosan0204@gmail.com
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 | 05 | Month | 11 | Day |
Related information
URL releasing protocol
https://gamagori-hospital.com/
Publication of results
Published
Result
URL related to results and publications
https://gamagori-hospital.com/
Number of participants that the trial has enrolled
209
Results
The multiple logistic regression analysis following the univariate analysis revealed that age over 73 years was the most significant risk factor for undiagnosable AC. Female sex and severe AC were also significant risk factors for undiagnosable AC. The K value between ACCI and ASA-PS revealed a minimal concordance of 0.33.
Results date posted
| 2025 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study evaluated the DMP based on the TG18, focusing on older patients with AC.
Participant flow
This was a single-armed, single-center retrospective study.
Adverse events
None
Outcome measures
The primary outcome measure was the "undiagnosable" AC rate, and the secondary outcome measure was the degree of concordance of "unfit for surgery" decisions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2022 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054404
