UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048241 |
|---|---|
| Receipt number | R000054033 |
| Scientific Title | The impact of perioperative synbiotic treatment on improvement of morbidity and survival after major hepato-biliary-pancreatic surgery. |
| Date of disclosure of the study information | 2022/07/11 |
| Last modified on | 2024/07/03 18:15:33 |
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Basic information
Public title
The impact of perioperative synbiotic treatment on improvement of morbidity and survival after major hepato-biliary-pancreatic surgery.
Acronym
SYMBIO-HBP
Scientific Title
The impact of perioperative synbiotic treatment on improvement of morbidity and survival after major hepato-biliary-pancreatic surgery.
Scientific Title:Acronym
SYMBIO-HBP
Region
| Japan |
Condition
Condition
Liver cancer, biliary tract cancer, pancreatic cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of perioperative synbiotic treatment on improvement of morbidity and survival after major hepato-biliary-pancreatic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of postoperative complication,
completion rate of adjuvant therapy
Key secondary outcomes
Assessment of sarcopenia
PNI (prognostic nutritional index)
Assessment of bacterial flora in the discharge of abdominal drain and stool
Serum cytokine
Recurrence free survival
Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Symbiotic treatment (Clostridium butyricum miyairi 588 and GFO (Glutamine, Fiber, and Oligosaccharide)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with hepato-biliary-pancreatic cancers who will undergo the operation.
Key exclusion criteria
Patients who do not consent to attend the study.
Patients who have already taken the Probiotics when they receive the informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Hirono |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
663-8501
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
se-hirono@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ikuo |
| Middle name | |
| Last name | Nakamura |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery
Zip code
6638501
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
Homepage URL
ikuon@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board Hyogo Medical University
Address
1-1, Mukogawa town Nishinomiya city, Hyogo prefecture, Japan
Tel
0798-45-6066
rinri@hyo-med.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
| 2022 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054033
