Pancreatic Cancer
Conditions
Brief summary
The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma. Hypotheses: 1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma. 2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL)
Interventions
subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure. * Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS. * Subjects undergoing EUS for pancreatic cancer staging. * Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis. * No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. Subjects must not have a coagulopathy (platelet \<50,000, INR\>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care. * Subjects must provide signed written informed consent. * A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.
Exclusion criteria
* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical). * Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol. * Subjects with uncorrectable coagulopathy * Subjects with an allergy to bupivacaine or alcohol. * Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 mL of Alcohol Injection subject randomized to 10ml of dehydrated alcohol | 10 |
| 20 mL of Alcohol Injection subject randomized to 20ml of dehydrated alcohol | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | 10 mL of Alcohol Injection | 20 mL of Alcohol Injection | Total |
|---|---|---|---|
| Age Continuous | 66 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection
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.
Time frame: baseline up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mL of Alcohol Injection | 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 |
| 20 mL of Alcohol Injection | The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection | 8.4 units on a scale | Standard Deviation 9.2 |