Trial Outcomes & Findings for A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration (NCT NCT01929460)
NCT ID: NCT01929460
Last Updated: 2016-02-15
Results Overview
first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
At 2 weeks after procedure
Results posted on
2016-02-15
Participant Flow
Participant milestones
| Measure |
Ciprofloxacin (Standard Group)
Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.
Ciprofloxacin 500mg by mouth twice a day for three days.
Ciprofloxacin
|
Placebo (Intervention Group)
Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration
Oral Placebo, one cap twice a day for three days.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Baseline characteristics by cohort
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=99 Participants
|
68.5 years
n=107 Participants
|
68.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Number of fine needle aspiration (FNA) passes
|
1.46 passes
n=99 Participants
|
1.38 passes
n=107 Participants
|
1.42 passes
n=206 Participants
|
PRIMARY outcome
Timeframe: At 2 weeks after procedurefirst time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: At 4 weeks after proceduresecond time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: At 6 weeks after procedurethird and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: six weeksNumber of participants with adverse drug reactions
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Adverse Drug Reactions
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: six weeks after procedureNumber of patients with procedure-related complications
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Procedure-related Complications
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: six weeksMean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Mean Cyst Fluid Carcinoembryonic Antigen (CEA)
|
214.1 ng/mL
Interval 0.2 to 1982.0
|
2466.2 ng/mL
Interval 0.2 to 24056.0
|
SECONDARY outcome
Timeframe: six weeksMean cyst fluid amylase for classification of mucinous cystic lesions
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Mean Cyst Fluid Amylase
|
3729 Units/L
Interval 30.0 to 7200.0
|
1944.5 Units/L
Interval 28.0 to 7200.0
|
SECONDARY outcome
Timeframe: six weeksMedian cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Median Cyst Fluid Carcinoembryonic Antigen (CEA)
|
15 ng/mL
Interval 3.4 to 74.5
|
24.9 ng/mL
Interval 0.35 to 248.5
|
SECONDARY outcome
Timeframe: six weeksMedian cyst fluid amylase for classification of mucinous cystic lesions
Outcome measures
| Measure |
Ciprofloxacin (Standard Group)
n=13 Participants
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.
Ciprofloxacin
|
Placebo (Intervention Group)
n=13 Participants
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Median Cyst Fluid Amylase
|
4006.5 Units/L
Interval 167.5 to 7200.0
|
239 Units/L
Interval 144.0 to 2930.0
|
Adverse Events
Drug (Standard Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug (Standard Group)
n=13 participants at risk
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.
Ciprofloxacin
|
Intervention Group
n=13 participants at risk
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/13 • 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.
|
7.7%
1/13 • Number of events 1 • 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
| Measure |
Drug (Standard Group)
n=13 participants at risk
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.
Ciprofloxacin
|
Intervention Group
n=13 participants at risk
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.
Placebo (for ciprofloxacin)
|
|---|---|---|
|
Gastrointestinal disorders
pain
|
0.00%
0/13 • 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.
|
30.8%
4/13 • Number of events 4 • 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.
|
Additional Information
Karl Kwok, MD
Kaiser Permanente, Los Angeles Medical Center
Phone: 800-954-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place