Clinical trial NCT03152487: Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Carcinoma Metastatic
Pancreatic Adenocarcinoma
Pancreatic Neoplasms
Pancreatic Cancer
Pancreatic Cancer, Adult
Keywords: endoscopic ultrasound
celiac plexus neurolysis
radiofrequency ablation
pancreatic cancer
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will randomized to either a group that receives Celiac Plexus Neurolysis or Radiofrequency Ablation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subject assessment of abdominal pain
timeFrame: Baseline to 4 week follow up
Secondary outcomes:
measure: Subject assessment of Quality of Life.
timeFrame: Baseline; 2 week follow up; 4 week follow up
measure: Narcotic Use
timeFrame: Initial visit; 2 week follow up; 4 week follow up
measure: Crossover to alternate technique
timeFrame: 48 hours post procedure; 2 week follow up; 4 week follow up
measure: Adverse effects, and endoscopic adverse events
timeFrame: 48 hours post procedure; 2 week follow up; 4 week follow up
measure: Survival rate
timeFrame: 2 week follow up; 4 week follow up
measure: Pain per the VAS tool.
timeFrame: Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy - Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam S Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yan BM, Myers RP. Neurolytic celiac plexus block for pain control in unresectable pancreatic cancer. Am J Gastroenterol. 2007 Feb;102(2):430-8. doi: 10.1111/j.1572-0241.2006.00967.x. Epub 2006 Nov 13.
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citation: World Health Organization. Cancer pain relief, 2nd Ed. Geneva: WHO, 2006
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citation: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
citation: Bang JY, Hasan MK, Sutton B, Holt BA, Navaneethan U, Hawes R, Varadarajulu S. Intraprocedural increase in heart rate during EUS-guided celiac plexus neurolysis: Clinically relevant or just a physiologic change? Gastrointest Endosc. 2016 Nov;84(5):773-779.e3. doi: 10.1016/j.gie.2016.03.1496. Epub 2016 Apr 2.
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citation: Bang JY, Sutton B, Hawes RH, Varadarajulu S. EUS-guided celiac ganglion radiofrequency ablation versus celiac plexus neurolysis for palliation of pain in pancreatic cancer: a randomized controlled trial (with videos). Gastrointest Endosc. 2019 Jan;89(1):58-66.e3. doi: 10.1016/j.gie.2018.08.005. Epub 2018 Aug 16.