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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007277
Receipt No. 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

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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
Email

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
Email satoi@hirakata.kmu.ac.jp

Sponsor
Institute Department of Surgery, Kansai Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008583

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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