UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039440 |
|---|---|
| Receipt number | R000044965 |
| Scientific Title | Investigation of the occult-bacterial translocation induced by surgical stress |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/09 17:44:40 |
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Basic information
Public title
Investigation of the occult-bacterial translocation induced by surgical stress
Acronym
O-BT induced by surgical stress
Scientific Title
Investigation of the occult-bacterial translocation induced by surgical stress
Scientific Title:Acronym
O-BT induced by surgical stress
Region
| Japan |
Condition
Condition
Patients undergoing highly invasive abdominal surgery.
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence of occult-bacterial translocation induced by surgical stress.
Basic objectives2
Others
Basic objectives -Others
To investigate the impact of occult-bacterial translocation on postoperative course.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of occult-bacterial translocation induced by surgical stress and its impact on postoperative course.
Key secondary outcomes
The association of the preoperative intestinal microenvironment and the incidence of occult-bacterial translocation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Collect fecal sample before surgery.
Collect blood sample immediately after the induction of general anesthesia and after the completion of surgery.
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
Patients who are going to undergo highly invasive abdominal surgery as the followings:
* Major hepatectomy (with and without extrahepatic bile duct resection)
* Pancreatoduodenectomy
* Hepatopancreatoduodenectomy
* Distal pancreatectomy with celiac axis resection
* Subtotal esophagectomy
* Other surgeries, which are considered highly invasive by the primary investigator
Key exclusion criteria
* Patients who reject participation for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japana
Tel
0527442061
ethics@med.nagoya-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 | 03 | Month | 01 | 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
| 2020 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044965
| 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 |
