UMIN-CTR Clinical Trial

Basic information
Public title	The examination of efficacy of perioperative synbiotics treatment to prevent postoperative infectious complications following pancreatoduodenectomy.
Acronym	The examination of efficacy of synbiotics treatment.
Scientific Title	The examination of efficacy of perioperative synbiotics treatment to prevent postoperative infectious complications following pancreatoduodenectomy.
Scientific Title:Acronym	The examination of efficacy of synbiotics treatment.
Region	Japan

Condition
Condition	Pancreatic tumor Biliary tract tumor Duodenal tumor Gastric tumor Pancreatitis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of perioperative synbiotics treatment in preventing postoperative infectious complications following pancreatoduodenectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of microbes in mesenteric lymph node.
Key secondary outcomes	Incidence of postoperative infectious complications.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Pre- and postoperative synbiotics treatment
Interventions/Control_2	Control: postoperative synbiotics treatment
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 fulfilled the criteria of this study and agreed with the enrollment in this study.
Key exclusion criteria	patients who reject to be enrolled in this study. patients who are infected with some infectious diseases and receive antibiotics within 1 week before the operation. patients who were not able to accomplish surgery. patients who are not fulfilled the criteria of this study.
Target sample size	40

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 Surgical Oncology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL	052-744-2222
Email	t_miyake777@yahoo.co.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 Surgical Oncology
Zip code
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aich, Japan
TEL	052-744-2222
Homepage URL
Email	t_miyake777@yahoo.co.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	Self funding
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	名古屋大学医学部付属病院(愛知県)

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 03 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	Completed
Date of protocol fixation	2010 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 06 Month 03 Day
Last modified on	2015 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004334

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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