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

Primary Purpose

Pancreatic Cysts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ciprofloxacin

Placebo (for ciprofloxacin)

About this trial

This is an interventional prevention trial for Pancreatic Cysts

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Kaiser Permanente, Los Angeles Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Drug (Standard group)

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

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)

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)

Secondary Outcome Measures

Adverse Drug Reactions

Number of participants with adverse drug reactions

Procedure-related Complications

Number of patients with procedure-related complications

Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

Mean Cyst Fluid Amylase

Mean cyst fluid amylase for classification of mucinous cystic lesions

Median Cyst Fluid Carcinoembryonic Antigen (CEA)

Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

Median Cyst Fluid Amylase

Median cyst fluid amylase for classification of mucinous cystic lesions

Full Information

NCT ID

NCT01929460

First Posted

August 13, 2013

Last Updated

January 13, 2016

Sponsor

Kaiser Permanente

1. Study Identification

Unique Protocol Identification Number

NCT01929460

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cysts

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug (Standard group)

Arm Type

Other

Arm Description

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.

Arm Title

Intervention group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Other Intervention Name(s)

Cipro

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo (for ciprofloxacin)

Other Intervention Name(s)

sugar pill formulated to mimic oral ciprofloxacin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time Frame

At 2 weeks after procedure

Title

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

Description

second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time Frame

At 4 weeks after procedure

Title

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

Description

third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)

Time Frame

At 6 weeks after procedure

Secondary Outcome Measure Information:

Title

Adverse Drug Reactions

Description

Number of participants with adverse drug reactions

Time Frame

six weeks

Title

Procedure-related Complications

Description

Number of patients with procedure-related complications

Time Frame

six weeks after procedure

Title

Mean Cyst Fluid Carcinoembryonic Antigen (CEA)

Description

Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

Time Frame

six weeks

Title

Mean Cyst Fluid Amylase

Description

Mean cyst fluid amylase for classification of mucinous cystic lesions

Time Frame

six weeks

Title

Median Cyst Fluid Carcinoembryonic Antigen (CEA)

Description

Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions

Time Frame

six weeks

Title

Median Cyst Fluid Amylase

Description

Median cyst fluid amylase for classification of mucinous cystic lesions

Time Frame

six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Kwok, MD

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente, Los Angeles Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15758904

Citation

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.

Results Reference

background

PubMed Identifier

15765442

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. doi: 10.1016/s1542-3565(04)00618-4.

Results Reference

background

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

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