Pancreatic CystsNCT01929460

A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration

A study testing Ciprofloxacin in people with Pancreatic Cysts, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Pancreatic Cysts
What is being tested?: Ciprofloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation

Who cannot join

Patients outside the age range
Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro)
High-risk patients for infective endocarditis
Bacterial infection or use of antibiotics within 6 weeks of EUS
Pancreatitis within the past 6 months
Underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin A1c above 7 or glucose > 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; HIV/AIDS)

Show all 9Show fewer

Currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant)
Radiographic or endosonographic evidence of cyst cavity debris / necrotic debris
Severe systemic disease (for example, NYHA class III or IV heart failure, oxygen-dependent COPD)

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente, Los Angeles Medical Center
Los Angeles, California, 90027

Other trials in United States

About this study

Official title: A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study

Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

Read the detailed description

With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered.

A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA).

Current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. However, these recommendations are based on limited data from over 15 years ago. More recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.

Conditions: Pancreatic Cysts
Being tested: Ciprofloxacin, Placebo (for ciprofloxacin)
Medical subject headings: Pancreatic Cyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CiprofloxacinDrug
Also called Cipro
ciprofloxacin oral capsule (one capsule twice a day for 3 days)
Placebo (for ciprofloxacin)Other
Also called sugar pill formulated to mimic oral ciprofloxacin
oral placebo capsule (one capsule twice a day for 3 days)

Study groups in NCT01929460
Study group	Role	What they receive
Drug (Standard group)	Other	Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration. Ciprofloxacin 500mg by mouth twice a day for three days. Receives: Drug: Ciprofloxacin
Intervention group	Placebo comparator	Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration Oral Placebo, one cap twice a day for three days. Receives: Other: Placebo (for ciprofloxacin)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Measured: At 2 weeks after procedure
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Measured: At 4 weeks after procedure
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Measured: At 6 weeks after procedure

Secondary outcomes (6)

Adverse Drug Reactions
Number of participants with adverse drug reactions
Measured: six weeks
Procedure-related Complications
Number of patients with procedure-related complications
Measured: six weeks after procedure
Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Measured: six weeks
Mean Cyst Fluid Amylase
Mean cyst fluid amylase for classification of mucinous cystic lesions
Measured: six weeks
Median Cyst Fluid Carcinoembryonic Antigen (CEA)
Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Measured: six weeks
Median Cyst Fluid Amylase
Median cyst fluid amylase for classification of mucinous cystic lesions
Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2014

First posted28 Aug 2013 (estimated)
Study startJan 2014
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pancreatic CystsStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01929460
Sponsor's protocol ID: 1
Status last verified: Jan 2016
First submitted: 13 Aug 2013
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jacobson BC, Baron TH, Adler DG, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; American Society for Gastrointestinal Endoscopy. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc. 2005 Mar;61(3):363-70. doi: 10.1016/s0016-5107(04)02779-8. No abstract available.
PubMed 15758904
Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4.
PubMed 15765442

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
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All Pancreatic Cysts trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Placebo-controlled Trial on the Use of Antibiotics for Pancreatic Cyst Aspiration: a Pilot Study
ClinicalTrials.gov ID: NCT01929460
Acronym / sponsor ID: 1
Conditions: Pancreatic Cysts
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Study start: Jan 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 28 Aug 2013 (estimated)
Results: Posted 31 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Our hypothesis is that a single dose of antibiotics at time of EUS-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

Detailed description

With the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered.

A critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (EUS-FNA).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drug (Standard group)	Other	Drug: CiprofloxacinStandard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration. Ciprofloxacin 500mg by mouth twice a day for three days.
Intervention group	Placebo comparator	Other: Placebo (for ciprofloxacin)Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration Oral Placebo, one cap twice a day for three days.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients between the age of 18-90 who present for an EUS / pancreas cyst evaluation

Key exclusion criteria (9 listed)

Patients outside the age range
Patient-related factors (unable to provide consent, unable to understand English, allergic to cipro)
High-risk patients for infective endocarditis
Bacterial infection or use of antibiotics within 6 weeks of EUS
Pancreatitis within the past 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CiprofloxacinAlso: Ciprociprofloxacin oral capsule (one capsule twice a day for 3 days)	Drug	Drug (Standard group)
Placebo (for ciprofloxacin)Also: sugar pill formulated to mimic oral ciprofloxacinoral placebo capsule (one capsule twice a day for 3 days)	Other	Intervention group

Primary outcome

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
Time frame: At 2 weeks after procedure
first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
Time frame: At 4 weeks after procedure
second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
Time frame: At 6 weeks after procedure
third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

6 secondary outcomes

Adverse Drug Reactions
Time frame: six weeks
Procedure-related Complications
Time frame: six weeks after procedure
Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
Time frame: six weeks
Mean Cyst Fluid Amylase
Time frame: six weeks
Median Cyst Fluid Carcinoembryonic Antigen (CEA)
Time frame: six weeks
Median Cyst Fluid Amylase
Time frame: six weeks

Results and safety

Results posted to the registry on 31 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ciprofloxacin (Standard Group)	13	13
Placebo (Intervention Group)	13	13

Primary outcome: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

Time frame: At 2 weeks after procedure. Number. Unit: participants

Measure	Ciprofloxacin (Standard Group) n = 13	Placebo (Intervention Group) n = 13
Value	0	0

Primary outcome: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

Time frame: At 4 weeks after procedure. Number. Unit: participants

Measure	Ciprofloxacin (Standard Group) n = 13	Placebo (Intervention Group) n = 13
Value	0	0

Primary outcome: Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration

Time frame: At 6 weeks after procedure. Number. Unit: participants

Measure	Ciprofloxacin (Standard Group) n = 13	Placebo (Intervention Group) n = 13
Value	0	0

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were prospectively monitored during the study period (1/1/2014-12/31/2014) at 2, 4, 6 weeks post procedure, or if the patient contacted the on-call research staff at any time after hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug (Standard Group)	0 of 13 (0%)	0 of 13 (0%)	Not reported
Intervention Group	1 of 13 (7.7%)	4 of 13 (30.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15758904Jacobson BC, Baron TH, Adler DG, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; American Society for Gastrointestinal Endoscopy. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc. 2005 Mar;61(3):363-70. doi: 10.1016/s0016-5107(04)02779-8. No abstract available.
Background: PubMed 15765442Lee LS, Saltzman JR, Bounds BC, Poneros JM, Brugge WR, Thompson CC. EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Clin Gastroenterol Hepatol. 2005 Mar;3(3):231-6. doi: 10.1016/s1542-3565(04)00618-4.

Related trials for Pancreatic Cysts

Not yet recruitingObservational study
AI-Assisted Differentiation of Pancreatic Cystic Lesions Using EUS Images and Clinical Features
Pancreatic Mucinous Cystic Neoplasm, Pancreatic Serous Cystic Neoplasm
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
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Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Recruiting
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RecruitingObservational study
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karl Kwok, MD principal investigator

Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ciprofloxacin in people with Pancreatic Cysts, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration (time frame: At 2 weeks after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01929460, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.