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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008393
Receipt No. R000009867
Scientific Title Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Date of disclosure of the study information 2012/07/28
Last modified on 2019/01/15

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Basic information
Public title Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Acronym Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Scientific Title Effect of optimal administration of antibiotics on prevention for pancreatic fistula
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuyuki Suzuki
Organization Kagawa University
Division name Department of Gastroenterological Surgery
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Okano
Organization Kagawa University
Division name Department of Gastroenterological Surgery
Zip code
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)

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 07 Month 28 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 Terminated
Date of protocol fixation
2012 Year 05 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009867

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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