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

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ClinicalTrials.gov Identifier: NCT03152487
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Metastatic Pancreatic Adenocarcinoma Pancreatic Neoplasms Pancreatic Cancer Pancreatic Cancer, Adult Other: Celiac Plexus Neurolysis Other: Radiofrequency Ablation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will randomized to either a group that receives Celiac Plexus Neurolysis or Radiofrequency Ablation.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: Celiac Plexus Neurolysis
This intervention involves accessing the Celiac Plexus Nerve via endoscopic guided ultrasound and then injecting the nerve bundle with bupivacaine.

Active Comparator: 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.
Other: Radiofrequency Ablation
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.




Primary Outcome Measures :
  1. Subject assessment of abdominal pain [ Time Frame: 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 :
  1. Subject assessment of Quality of Life. [ Time Frame: 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)

  2. Narcotic Use [ Time Frame: 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.

  3. Crossover to alternate technique [ Time Frame: 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).

  4. Adverse effects, and endoscopic adverse events [ Time Frame: 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

  5. Survival rate [ Time Frame: 2 week follow up; 4 week follow up ]
    Information regarding if the subject is alive or deceased.

  6. Pain per the VAS tool. [ Time Frame: 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152487


Locations
United States, Florida
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Florida Hospital
Investigators
Principal Investigator: Shyam S Varadarajulu, MD Florida Hospital

Publications:
World Health Organization. Cancer pain relief, 2nd Ed. Geneva: WHO, 2006

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT03152487     History of Changes
Other Study ID Numbers: 1035541
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data (IPD).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Florida Hospital:
endoscopic ultrasound
celiac plexus neurolysis
radiofrequency ablation
pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases