UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003705 |
|---|---|
| Receipt number | 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 13:07:57 |
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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
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
t_miyake777@yahoo.co.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
Self funding
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004334
