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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003705
Receipt No. R000004334
Scientific Title The examination of efficacy of perioperative synbiotics treatment to prevent postoperative infectious complications following pancreatoduodenectomy.
Date of disclosure of the study information 2010/06/03
Last modified on 2015/06/03

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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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