UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008393 |
|---|---|
| Receipt number | R000009867 |
| Scientific Title | Effect of optimal administration of antibiotics on prevention for pancreatic fistula |
| Date of disclosure of the study information | 2012/07/28 |
| Last modified on | 2019/01/15 10:11:05 |
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Basic information
Public title
Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Acronym
Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Scientific Title
Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Scientific Title:Acronym
Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Region
| Japan |
Condition
Condition
Pancreas tumor, Pancreas lesion
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of optimal antibiotics on prevention for pancreatic fistula in the period of drain removal
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pancreatic fistula
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, the patients receive antibiotics
Interventions/Control_2
In the control group, the patients don't receive antibiotics
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 will undergo pancreatic resection (PD, SSPPD, PPPD, DP)
Key exclusion criteria
1) Patients with inflammatory lesion
2) Patients with allergy for antibiotics
3) Patients who were deemed inappropriate for medical reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Suzuki |
Organization
Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Okano |
Organization
Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
Address
TEL
0878912438
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, Kagawa 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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009867
