Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001305718
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
22/11/2013
Date last updated
22/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes of single dose peri-procedural antibiotic prophylaxis for endoscopic ultrasound guided fine needle aspiration of pancreatic cystic lesions.
Scientific title
Rates of infection in patients with pancreatic cyst endoscopic ultrasound fine needle aspiration given antibiotic prophylaxis
Secondary ID [1] 283076 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cyst 289914 0
Infection 290579 0
Condition category
Condition code
Oral and Gastrointestinal 290282 290282 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 290975 290975 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients having endoscopic ultrasound fine needle aspiration are at risk of iatrogenic infections due to the procedure. Currently there are no firm guidelines as to whether antibiotics are required or if they are, what antibiotics should be used. There have been no studies focusing on Tazocin (tazobactam, piperacillin) at the time of endoscopic ultrasound fine needle aspiration (EUS FNA). We will include all cases of EUS FNA requiring antibiotic prophylaxis and follow up patients following discharge home to determine whether they develop acute or chronic infections.

Observational study will be conducted determining the rates of sepsis following EUS FNA (single periprocedural dose IV tazocin or ciprofloxacin) on telephone follow up 1 year post-procedure
Intervention code [1] 287792 0
Not applicable
Comparator / control treatment
NA - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290316 0
Infection - abscess, peritonitis, septicaemia. Based on actual presentation of a complication and formal diagnosis being obtained of infectious complication according to standard clinical definitions based upon history, examination and relevant investigations.
Timepoint [1] 290316 0
Assessed at 1 year after the procedure and includes outcomes such as infections or complications up to the time of follow up.
Secondary outcome [1] 304292 0
Antibiotic complications: allergic reaction, c difficile infection. Based on actual presentation of a complication and formal diagnosis being obtained of infectious complication according to standard clinical definitions based upon history, examination and relevant investigations.
Timepoint [1] 304292 0
Assessed at 1 year after the procedure. Any complications occurring up to 1 year are obtained at follow up.

Eligibility
Key inclusion criteria
Age 16 - 90
Pancreatic cyst requiring fine needle aspiration
Consenting to procedure
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coagulopathy
Not possible to safely perform EUS FNA eg cyst not well-positioned

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
No power calculation. Convenience sample of 75 to 100.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
4/02/2011
Date of last participant enrolment
Anticipated
10/01/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287838 0
Hospital
Name [1] 287838 0
Concord Hospital
Country [1] 287838 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Concord Hospital
Gastroenterology and Liver Services
Hospital Rd LEvel 1 West
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 286563 0
None
Name [1] 286563 0
Address [1] 286563 0
Country [1] 286563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289778 0
Concord Hospital Human Research Ethics Committee
Ethics committee address [1] 289778 0
Concord Hospital Human Research Ethics Committee
Concord Hospital
Hospital Rd
Concord NSW 2139
Ethics committee country [1] 289778 0
Australia
Date submitted for ethics approval [1] 289778 0
03/08/2012
Approval date [1] 289778 0
28/09/2012
Ethics approval number [1] 289778 0
EC00118

Summary
Brief summary
Endoscopic ultrasound can obtain fluid using a technique known as fine needle aspiration (FNA). This involves a needle entering a pancreatic cyst and sucking fluid out. However, this test risks introducing gut bacteria into a normally sterile space. As such antibiotics may be effective to prevent infections. We aim to test whether Tazocin or Ciprofloxacin if penicillin allergy is present, prevents infections or is associated with increased harm.
Trial website
Trial related presentations / publications
Public notes
The use of IV tazocin/ ciprofloxacin is considered standard practice at Concord Hospital approved by the Endoscopy Unit. An audit was commenced with Ethics Approval to contact patients from 28 Sep 2012. Contacting patients was considered a low risk application and provided the necessary data of complications following the EUS FNA procedure. It is also part of an ongoing quality audit of EUS FNA by the department to ensure that even late complications are recorded.

Contacts
Principal investigator
Name 42382 0
A/Prof Rupert Leong
Address 42382 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 42382 0
Australia
Phone 42382 0
61297676111
Fax 42382 0
61297676767
Email 42382 0
[email protected]
Contact person for public queries
Name 42383 0
A/Prof Rupert Leong
Address 42383 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 42383 0
Australia
Phone 42383 0
61297676111
Fax 42383 0
61297676767
Email 42383 0
[email protected]
Contact person for scientific queries
Name 42384 0
A/Prof Rupert Leong
Address 42384 0
Concord Hospital
Level 1 West
Hospital Rd
Concord NSW 2139
Country 42384 0
Australia
Phone 42384 0
61297676111
Fax 42384 0
61297676767
Email 42384 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.