Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis



Status:Completed
Conditions:Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:2/13/2019
Start Date:April 24, 2017
End Date:August 1, 2018

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Randomized Trial Comparing Endoscopic Ultrasound-guided Radiofrequency Ablation vs.Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Alleviation of Abdominal Pain in Patients With Pancreatic Cancer

Pancreatic cancer is the second most common gastrointestinal malignancy. Abdominal discomfort
is a main symptom in patients with pancreatic cancer. Approximately 75% have pain at
diagnosis and over 90% in advanced stages. Pain control is an important part of the plan of
care for patients with pancreatic cancer.. The celiac plexus is a group of nerves that supply
organs in the abdomen. EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely used for
pain management in patients with pancreatic cancer. Radiofrequency ablation of celiac ganglia
or celiac plexus (EUS-RFA) is also being performed to alleviate abdominal pain in pancreatic
cancer patients. However currently no comparative studies exist comparing EUS-CPN with
EUS-RFA. The purpose of the study is to compare EUS-CPN with EUS-RFA for pain management in
pancreatic patients, in order to determine which technique is better at improving pain in
pancreatic cancer patients.

Pancreatic cancer is the second most common gastrointestinal malignancy and fourth leading
cause of cancer mortality. The incidence in the US is estimated at 8.8 per 100,000 population
with 30,000 new cases diagnosed annually. The prognosis of unresectable pancreatic cancer is
poor; overall 1 and 5-year survivals do not exceed 20 and 4%, respectively. For the minority
of patients (15%) who are resectable at diagnosis, the median survival is 10-20 months, with
5-year survival of 10-25%.

Abdominal discomfort is a predominant symptom in patients with pancreatic cancer.
Approximately 75% have pain at diagnosis and over 90% in advanced stages. Therefore a major
aspect of palliation is provision of adequate pain control. The standard approach to pain
management is based on the World Health Organization (WHO) 3-step ladder, beginning with
non-opioid analgesics (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen),
followed by weak opioids and then finally strong opioids as necessary. Virtually all patients
require escalating doses of opioids during their disease. Adjuvant therapies, including other
medications (e.g. trazodone, tricyclic anti-depressants, and bisphosphonates), palliative
radionucleotides, external beam radiation, or chemotherapy may also be useful for symptomatic
control.

In the last 10 years, EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely practiced
for alleviation of pain in patients with pancreatic cancer and has been shown to be
effective. At our institution, radiofrequency ablation (EUS-RFA), which involves ablation of
celiac ganglia or celiac plexus using a radiofrequency catheter, is being performed to
alleviate abdominal pain in pancreatic cancer patients. However currently no comparative
studies exist comparing EUS-CPN with EUS-RFA for pain alleviation in pancreatic cancer
patients.

In this randomized trial, the investigators will be comparing EUS-CPN with EUS-RFA for pain
alleviation in pancreatic patients, in order to determine which technique is better at
improving pain in pancreatic cancer patients.

Inclusion Criteria:

1. Age ≥ 19 years

2. The subject is capable of understanding and complying with protocol requirements.

3. The subject is able to understand and willing to sign an informed consent form prior
to the initiation of any study procedures.

4. Abdominal pain typical for pancreatic cancer

5. Cross-sectional imaging findings consistent with pancreatic cancer

6. Pancreatic cancer confirmed by EUS-FNA in patients referred for suspected pancreatic
cancer OR Patients with known diagnosis of pancreatic cancer

7. Inoperable pancreatic cancer as determined during EUS or prior CT

Exclusion Criteria:

1. Age <19 years

2. Unable to obtain consent for the procedure from the patient

3. Unable to safely undergo EUS for any reason

4. Irreversible coagulopathy (Prothrombin time > 18 secs, platelet count < 50,000/ml)

5. Previous CPN or other neurolytic block that could affect pancreatic cancer-related
pain or had implanted epidural or intrathecal analgesic therapy

6. Another cause for abdominal pain such as pseudocyst, ulcer or other intraabdominal
disorder

7. Pregnant women will be excluded. This will be confirmed by self-report. Pregnancy in
females of childbearing potential will be determined by routine preoperative urine or
serum Human Chorionic Gonadotropin (HCG) testing.
We found this trial at
1
site
601 East Rollins Street
Orlando, Florida 32803
1140
mi
from
Orlando, FL
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