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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.

Sponsor: Kaiser Permanente

Current 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)

Original 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 [ Time Frame: At 4 weeks after procedure ]
  second time point
• 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

Current Secondary Outcome:

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

Original Secondary Outcome:

• Secondary outcomes [ Time Frame: six weeks ]
  1. adverse drug reactions
• secondary outcome [ Time Frame: six weeks ]
  2. procedure-related complications
• secondary outcome [ Time Frame: six weeks ]
  3. performance of cyst fluid markers for classification of mucinous cystic lesions

Information By: Kaiser Permanente

Dates:
Date Received: August 13, 2013
Date Started: January 2014
Date Completion:
Last Updated: January 13, 2016
Last Verified: January 2016