UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040486
Receipt No. 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 2020/05/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
90 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 70

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
Email 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
Email k-gyoten@clin.medic.mie-u..ac.jp

Sponsor
Institute Department of Hepatobiliary Pancreatic and Transplant Surgery, Mie University School of Medicine
Institute
Department

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
Email 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 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046210

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.