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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001278
Receipt No. R000001555
Scientific Title Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.
Date of disclosure of the study information 2008/08/01
Last modified on 2013/09/09

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Basic information
Public title Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.
Acronym RCT on perioperative antimicrobial therapy in biliary surgery.
Scientific Title Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.
Scientific Title:Acronym RCT on perioperative antimicrobial therapy in biliary surgery.
Region
Japan

Condition
Condition Hepato-biliary-pancreatic diseases
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized clinical trial is to determine whether therapeutic usage of antimicrobial agents according to the result of preoperative bile culture in patients undergoing the biliary reconstruction treated as Class3 (contaminated) by CDC (Centers for Disease Control and Prevention) guideline during the perioperative period can reduce surgical site infection (SSI) occurrence rates compared with prophylactic usage of antimicrobial agents recommended by CDC guideline as Class2 (clean-contaminated).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the incidence of SSI occurrence rates within postoperative 30 days between 2 groups (therapeutic usage of antimicrobial agents treated as Class3 by CDC guideline and prophylactic usage of antimicrobial agents recommended by CDC guideline as Class2).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Antimicrobial prophylaxis (second-generation cephalosporin) are administered for three days in perioperative period recommended by CDC guideline as Class2.
Interventions/Control_2 Therapeutic antimicrobial agents according to the result of preoperative bile culture are administered for three days in perioperative period treated as Class3 by CDC guideline.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Males and females over 18 years old, and with hepatobiliary and pancreatic diseases who have undergone external biliary drainage (endoscopic nasobiliary drainage: ENBD or percutaneous transhepatic biliary drainage: PTBD) before operation.
Key exclusion criteria Patients with renal dysfunction, sever liver dysfunction or a history of antimicrobial agents -induced allergy.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirano
Organization Hokkaido university hospital
Division name Gastroenterological sutgery II
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo Japan
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kunishige Okamura
Organization Hokkaido university hospital
Division name Gastroenterological sutgery II
Zip code
Address Kita 14, Nishi 5, Kita-ku, Sapporo Japan
TEL
Homepage URL
Email

Sponsor
Institute Hokkaido university hospital gastroenterological sutgery II
Institute
Department

Funding Source
Organization Hokkaido university hospital gastroenterological sutgery II
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
2008 Year 08 Month 01 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
2008 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2013 Year 03 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
2008 Year 07 Month 30 Day
Last modified on
2013 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001555

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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