UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007277 |
|---|---|
| Receipt number | R000008583 |
| Scientific Title | a multi-center, phaseII, prospective randomized study to investigate optimal duration of prophylactic antimicrobial agent in patients who undergo pancreatico-duodenectomy following preoperative biliary drainage |
| Date of disclosure of the study information | 2012/02/14 |
| Last modified on | 2018/08/19 17:35:54 |
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Basic information
Public title
a multi-center, phaseII, prospective randomized study to investigate optimal duration of prophylactic antimicrobial agent in patients who undergo pancreatico-duodenectomy following preoperative biliary drainage
Acronym
A prospective study to investigate optimal duration of prophylactic antimicrobial agent in patients who undergo pancreatico-duodenectomy
Scientific Title
a multi-center, phaseII, prospective randomized study to investigate optimal duration of prophylactic antimicrobial agent in patients who undergo pancreatico-duodenectomy following preoperative biliary drainage
Scientific Title:Acronym
A prospective study to investigate optimal duration of prophylactic antimicrobial agent in patients who undergo pancreatico-duodenectomy
Region
| Japan |
Condition
Condition
Patients without a symptom of cholangitis who have a planned pancreaticoduodenectomy following preoperative biliary drainage.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal duration of antimicrobial agent in patients who undergo pancreaticoduodenectomy following preoperative biliary drainage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of surgical site infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To administrate 1g of CZOP every 8hours until post-operative day4
Interventions/Control_2
To administrate 1g of CZOP every 8hours during pancreaticoduodenectomy
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
A patient without a symptom of cholangitis who have a planned pancreaticoduodenectomy following preoperative biliary drainage
Key exclusion criteria
1. a patient with a symptom of cholangitis after preoperative biliary drainage.
2. a patient with anaerobic bacteria detected after preoperative biliary drainage.
3. a patient with resistant bacteria detected after preoperative biliary drainage.
4. a young patient and a patient who has difficulty in self-decision-making
5. a patient who is inappropriate for study entry by a chief doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sohei SATOI MD |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Surgery, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kansai Medical University
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008583
