UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013987 |
|---|---|
| Receipt number | R000009087 |
| Scientific Title | Detection of intraoperative bacterial translocation in patients who undergo hepatectomy with extrahepatic bile duct resection or pancreatoduodenectomy. |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2018/05/21 14:35:17 |
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Basic information
Public title
Detection of intraoperative bacterial translocation in patients who undergo hepatectomy with extrahepatic bile duct resection or pancreatoduodenectomy.
Acronym
Detection of intraoperative bacterial translocation
Scientific Title
Detection of intraoperative bacterial translocation in patients who undergo hepatectomy with extrahepatic bile duct resection or pancreatoduodenectomy.
Scientific Title:Acronym
Detection of intraoperative bacterial translocation
Region
| Japan |
Condition
Condition
The patients who are going to undergo hepatectomy (excluding laparoscopic surgery) and pancreatoduodenectomy.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detection of intraoperative bacterial translocation during hepatectomy and pancreatoduodenectomy using portal venous blood and mesenteric lymph nodes.
Basic objectives2
Others
Basic objectives -Others
To elucidate the correlation between intraoperative bacterial translocation and postoperative inflammatory response and incidense of infectious complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of bacterium and (if present) amount of bacterium in the portal venous blood, mesenteric lymph nodes, and peripheral blood samples.
Key secondary outcomes
Correlation between the incidense of intraoperative bacterial translocation and inflammatory response on POD1, the incidense of postoperative infectious complicatoins, postoperative hospital stay, and the incidense of surgery-related death.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intraoperative sampling of portal venous blood and mesenteric lymph nodes.
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) Patients who are going to undergo hepatectomy with extrahepatic bile duct resection or pancreatoduodenectomy.
2) Patients who agreed with participation.
3) Patients who do not have severe organ dysfunction.
Key exclusion criteria
1) Patients who do not agree with participation.
2) Emergent surgery.
3) Patients who do have severe organ dysfunction.
4) Patients who have severe coagulopathy.
5) Patients who are evaluated inappropriate to participate the study by doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan 4668550
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2222
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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 18 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009087
