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

NCT01929460 | Completed Results

• 1 other identifier: 1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cysts

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (6)

• Adverse Drug Reactions

  six weeks

• Procedure-related Complications

  six weeks after procedure

• Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

  six weeks

• Mean Cyst Fluid Amylase

  six weeks

• Median Cyst Fluid Carcinoembryonic Antigen (CEA)

  six weeks

Study Arms (2)

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.

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.

Other: Placebo (for ciprofloxacin)

Interventions

Ciprofloxacin DRUG

ciprofloxacin oral capsule (one capsule twice a day for 3 days)

Also known as: Cipro

Drug (Standard group)

Placebo (for ciprofloxacin) OTHER

oral placebo capsule (one capsule twice a day for 3 days)

Also known as: sugar pill formulated to mimic oral ciprofloxacin

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Related 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. doi: 10.1016/s0016-5107(04)02779-8. No abstract available.

  PMID: 15758904 BACKGROUND

• 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.

  PMID: 15765442 BACKGROUND

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Ciprofloxacin; Sugars

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Karl Kwok, MD
• Organization: Kaiser Permanente, Los Angeles Medical Center

regional-research-committee@kp.org

800-954-8000

Study Officials

• Karl Kwok, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 28, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 15, 2016
• Results First Posted: December 31, 2015

Record last verified: 2016-01

Locations

US (1)