UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036140 |
|---|---|
| Receipt number | R000041144 |
| Scientific Title | Association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2019/05/15 10:48:53 |
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Basic information
Public title
Association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy
Acronym
Association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy
Scientific Title
Association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy
Scientific Title:Acronym
Association between bile infection and clinically relevant pancreatic fistula in patients undergoing pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Pancreatic cancer, bile duct cancer, IPMN, benign pancreatic tumor.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of the association between microorganisms isolated from intraoperative bile cultures and postoperative drain culture on clinically relevant postoperative pancreatic fistula.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of clinically relevant postoperative pancreatic fistula.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Between May 2013 and May 2018, patients who underwent pancreatoduodenectomy were included in the analysis.
Key exclusion criteria
Patients in whom intraoperative bile or postoperative drain fluid samples were not available, were excluded from this study.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
knaka@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8521
Address
Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
Homepage URL
knaka@naramed-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nara Medical University
Address
Shijo-cho, Kashihara, Nara 634-8522, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
| 2019 | Year | 05 | Month | 15 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041144
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