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

Pancreatic Cysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929460
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: January 13, 2016
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Cysts

Intervention

Drug:
• Ciprofloxacin
ciprofloxacin oral capsule (one capsule twice a day for 3 days)

Other:
• Placebo (for ciprofloxacin)
oral placebo capsule (one capsule twice a day for 3 days)

Locations

Country	Name	City	State
United States	Kaiser Permanente, Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At 2 weeks after procedure	No
Primary	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)	At 4 weeks after procedure	No
Primary	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)	At 6 weeks after procedure	No
Secondary	Adverse Drug Reactions	Number of participants with adverse drug reactions	six weeks	Yes
Secondary	Procedure-related Complications	Number of patients with procedure-related complications	six weeks after procedure	Yes
Secondary	Mean Cyst Fluid Carcinoembryonic Antigen (CEA)	Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions	six weeks	No
Secondary	Mean Cyst Fluid Amylase	Mean cyst fluid amylase for classification of mucinous cystic lesions	six weeks	No
Secondary	Median Cyst Fluid Carcinoembryonic Antigen (CEA)	Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions	six weeks	No
Secondary	Median Cyst Fluid Amylase	Median cyst fluid amylase for classification of mucinous cystic lesions	six weeks	No