Trial Outcomes & Findings for Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study (NCT NCT00578279)

Results Overview

Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

baseline up to 1 year

Results posted on

2012-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	10 mL of Alcohol Injection subject randomized to 10ml of dehydrated alcohol	20 mL of Alcohol Injection subject randomized to 20ml of dehydrated alcohol
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 mL of Alcohol Injection n=10 Participants subject randomized to 10ml of dehydrated alcohol	20 mL of Alcohol Injection n=10 Participants subject randomized to 20ml of dehydrated alcohol	Total n=20 Participants Total of all reporting groups
Age Continuous	66 years STANDARD_DEVIATION 14 • n=5 Participants	63 years STANDARD_DEVIATION 10 • n=7 Participants	64 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline up to 1 year

Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.

Outcome measures

Outcome measures
Measure	10 mL of Alcohol Injection n=10 Participants subject randomized to 10ml of dehydrated alcohol	20 mL of Alcohol Injection n=10 Participants subject randomized to 20ml of dehydrated alcohol
The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection	7.9 units on a scale Standard Deviation 10.8	8.4 units on a scale Standard Deviation 9.2

Adverse Events

10 mL of Alcohol Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20 mL of Alcohol Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia K. LeBlanc, MD

Indiana University Medical Center

Phone: (317) 948-8125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place