UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040486 |
|---|---|
| Receipt number | R000046210 |
| Scientific Title | The merit of preoperative culture of gastric juice in high-level hepatobiliary pancreatic surgeries (Do gastric culture results predict postoperative complications ?) |
| Date of disclosure of the study information | 2020/05/22 |
| Last modified on | 2020/08/06 12:44:00 |
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Basic information
Public title
The merit of preoperative culture of gastric juice in high-level hepatobiliary pancreatic surgeries (Do gastric culture results predict postoperative complications ?)
Acronym
The culture of gastric juice in HBP surgeries
Scientific Title
The merit of preoperative culture of gastric juice in high-level hepatobiliary pancreatic surgeries (Do gastric culture results predict postoperative complications ?)
Scientific Title:Acronym
The culture of gastric juice in HBP surgeries
Region
| Japan |
Condition
Condition
The patients who undergo high-level HBP surgeries
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An association between the culture of gastric juice collected preoperatively and post-operative complications is evaluated.
Basic objectives2
Others
Basic objectives -Others
The evaluation of bacterial and fungal species in gastric juice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of post-operative infectious complications within 30 days after operation
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have severe concomitant disease
2) Patients with ECOG-Performance Status 0 or 1
3) Patients who receive from a physician the information necessary to give informed consent
Key exclusion criteria
Patients whom principal investigator judged inappropriate for subjects of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kato |
Organization
Mie University Hospital
Division name
Hepatobiliary Pancreatic and Transplant Surgery
Zip code
514-8507
Address
2-174 Edobashi
TEL
059-232-1111
katohiroyuki510719@gmail.com
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Gyoten |
Organization
Mie University Hospital
Division name
The department of hepatobiliary pancreatic and transplant surgery
Zip code
514-8507
Address
2-174 Edobashi
TEL
09099211030
Homepage URL
k-gyoten@clin.medic.mie-u..ac.jp
Sponsor or person
Institute
Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine
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
Mie University Hospital
Address
2-174 Edobashi
Tel
058-232-1111
k-gyoten@clin.medic.mie-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
| 2020 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gastric juice is collected and cultured after general anesthesia induction. The incidents and the detail of postoperative complications are evaluated. Associations between microbiological species in gastric juice and post-operative complications are statistically evaluated.
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046210
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
