UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Usefulness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease
Title of the study (Brief title)	The Usefulness of Doripenem as a postoperative therapeutic antibiotics
Region	Japan

Condition
Condition	Resected cases with pancreato-biliary disease
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the usefuleness of Doripenem as a postoperative therapeutic antibiotics in cases with pancreato-biliary disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To verify the usefulness or non-inferiority of Doripenem to non-Carbapenem antibiotics in resected cases with pancreato-biliary disease
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To use Doripenemu for resected cases with pancreato-biliary disease
Interventions/Control_2
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Resected cases with pancreato-biliary disease
Key exclusion criteria	The cases which the doctors in charge judge inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	Ryutaro Mori
Organization	Yokohama City University Hospital
Division name	Department of Gastroenterological Surgery
Address	3-9, Fukuura Kanazawa Yokohama Kanagawa
TEL	045-787-2650
Email	ryutaromori@gmail.com

Public contact
Name of contact person	Ryutaro Mori
Organization	Yokohama City University
Division name	Department of Gastroenterological Surgery
Address	3-9, Fukuura Kanazawa Yokohama Kanagawa
TEL	045-787-2650
Homepage URL
Email	ryutaromori@gmail.com

Sponsor
Institute	Yokohama City University, Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	Yokohama City University, Department of Gastroenterological Surgery
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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 04 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2016 Year 12 Month 09 Day
Date of closure to data entry	2016 Year 12 Month 09 Day
Date trial data considered complete	2016 Year 12 Month 09 Day
Date analysis concluded	2016 Year 12 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 26 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017051