UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of intraoperative bacterial translocation in patients who undergo hepatectomy with extrahepatic bile duct resection or pancreatoduodenectomy.
Title of the study (Brief title)	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	Masato Nagino
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery, Division of Surgical Oncology
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	Yukihiro Yokoyama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery, Division of Surgical Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009087