UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Title of the study (Brief title)	Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Region	Japan

Condition
Condition	Pancreas tumor, Pancreas lesion
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of optimal antibiotics on prevention for pancreatic fistula in the period of drain removal
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of pancreatic fistula
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In the intervention group, the patients receive antibiotics
Interventions/Control_2	In the control group, the patients don't receive antibiotics
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	1) Patients who will undergo pancreatic resection (PD, SSPPD, PPPD, DP)
Key exclusion criteria	1) Patients with inflammatory lesion 2) Patients with allergy for antibiotics 3) Patients who were deemed inappropriate for medical reasons
Target sample size	300

Research contact person
Name of lead principal investigator	Yasuyuki Suzuki
Organization	Kagawa University
Division name	Department of Gastroenterological Surgery
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
Email

Public contact
Name of contact person	Keiichi Okano
Organization	Kagawa University
Division name	Department of Gastroenterological Surgery
Address
TEL	0878912438
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterological Surgery, Kagawa University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 07 Month 28 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 05 Month 14 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 07 Month 09 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009867