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

Not Applicable

Completed

• Conditions: Pancreatic Carcinoma Metastatic; Pancreatic Neoplasms; Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Cancer, Adult
• Interventions: Other: Celiac Plexus Neurolysis; Other: Radiofrequency Ablation

• Registration Number: NCT03152487
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2017-04-20
• Study Start: 2017-04-24
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2018-04-01
• Study Completion: 2018-08-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celiac Plexus Neurolysis	Celiac Plexus Neurolysis	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.
Radiofrequency Ablation	Radiofrequency Ablation	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.

Primary Outcome Measures

Name	Time	Method
Subject assessment of abdominal pain	Baseline to 4 week follow up	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.

Secondary Outcome Measures

Name	Time	Method
Narcotic Use	Initial visit; 2 week follow up; 4 week follow up	Subjects will be asked about their medication usage to manage pain and the answers will be documented.
Crossover to alternate technique	48 hours post procedure; 2 week follow up; 4 week follow up	Cross-over to the alternate technique due to inadequate response to the original technique (defined as \< 50% decrease in VAS score post-original technique).
Adverse effects, and endoscopic adverse events	48 hours post procedure; 2 week follow up; 4 week follow up	Information regarding complications if any, that the subject may have experienced, which can include hypotension, diarrhea, neuropathic pain, paraplegia and endoscopic adverse events
Survival rate	2 week follow up; 4 week follow up	Information regarding if the subject is alive or deceased.
Subject assessment of Quality of Life.	Baseline; 2 week follow up; 4 week follow up	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)
Pain per the VAS tool.	Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up	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.

Trial Locations

Locations (1)

Center for Interventional Endoscopy - Florida Hospital; 🇺🇸 Orlando, Florida, United States