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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013987
Receipt No. 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

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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
Email 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
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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