An interventional study of Celiac Plexus Neurolysis and Radiofrequency Ablation in Pancreatic Carcinoma Metastatic, Pancreatic Adenocarcinoma and Pancreatic Neoplasms, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
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.
3,311 studies on the registry are indexed under Pancreatic Neoplasms; 911 are open to participants now.
This study's enrollment of 28 is below the median of 46 across 2,481 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →AdventHealth is the lead sponsor of 113 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
CPN will be undertaken at the celiac space which is located between the aorta and the celiac artery origin. A 22 or 19-gauge Fine Needle Aspiration (FNA) needle is used, and its tip is placed slightly anterior and cephalic to the origin of the celiac artery. Aspiration is first performed using a syringe to ensure that vascular puncture has not occurred. 10 mL Bupivacaine is injected first, followed by 20 mL of 98% alcohol.
Other: Celiac Plexus Neurolysis
Once the celiac ganglia are identified on EUS, a 19-gauge FNA needle is inserted into the center of the ganglion or area of celiac plexus under EUS guidance. The radiofrequency (RF) probe (EMcision, Montreal, Canada) is advanced through the FNA needle. Radiofrequency ablation is performed via the probe for 90 seconds, followed by a 90 second rest and repeated as required.
Other: Radiofrequency Ablation
This intervention involves accessing the Celiac Plexus Nerve via endoscopic guided ultrasound and then injecting the nerve bundle with bupivacaine.
Radiofrequency ablation is performed via the probe for 90 seconds, followed by a 90 second rest. This is repeated until the entire ganglion becomes hyperechoic on EUS.
Subject assessment of abdominal pain
Abdominal pain will be assessed with pain scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer module (QLQ-PAN26). The questionnaire has 26 questions with scoring ranging from a minimum of 26 to a maximum of 104. The higher the score, the worse the subject's quality of life rating.
Time frame: Baseline to 4 week follow up
Subject assessment of Quality of Life.
Quality of life (QOL) as assessed by the quality of life instrument: the Functional Assessment of Cancer Therapy, Pancreatic Cancer (FACT-PA) (i.e. QLQ-30 and PAN-26)
Time frame: Baseline; 2 week follow up; 4 week follow up
Narcotic Use
Subjects will be asked about their medication usage to manage pain and the answers will be documented.
Time frame: Initial visit; 2 week follow up; 4 week follow up
Crossover to alternate technique
Cross-over to the alternate technique due to inadequate response to the original technique (defined as \< 50% decrease in VAS score post-original technique).
Time frame: 48 hours post procedure; 2 week follow up; 4 week follow up
Adverse effects, and endoscopic adverse events
Information regarding complications if any, that the subject may have experienced, which can include hypotension, diarrhea, neuropathic pain, paraplegia and endoscopic adverse events
Time frame: 48 hours post procedure; 2 week follow up; 4 week follow up
Survival rate
Information regarding if the subject is alive or deceased.
Time frame: 2 week follow up; 4 week follow up
Pain per the VAS tool.
Abdominal pain will be assessed with a standardized 11-point continous visual analog pain scale (with "0" equaling no pain, "5" moderate pain and "10" worst pain ever.
Time frame: Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up
Plan to share: No — There is no plan to share individual participant data (IPD).
Ran from Apr 2017 to primary completion in Apr 2018, 11 months.
Of 352 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 71. This study's 11 months is below that.
Counting every sponsor, half of 373 studies reached it within 48 months; a quarter within 26 and three quarters within 75.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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