UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Sohei SATOI MD
Organization	Kansai Medical University
Division name	Department of Surgery
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL
Email

Public contact
Name of contact person	Sohei SATOI MD
Organization	Kansai Medical University
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008583