Pancreatic Cancer Clinical Trial
Official title:
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.
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