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

February 8, 2019 updated by: AdventHealth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy - Florida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 4 week follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline; 2 week follow up; 4 week follow up
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.
Initial visit; 2 week follow up; 4 week follow up
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).
48 hours post procedure; 2 week follow up; 4 week follow up
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
48 hours post procedure; 2 week follow up; 4 week follow up
Survival rate
Time Frame: 2 week follow up; 4 week follow up
Information regarding if the subject is alive or deceased.
2 week follow up; 4 week follow up
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.
Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Shyam S Varadarajulu, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1035541

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual participant data (IPD).

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Neoplasms

Clinical Trials on Celiac Plexus Neurolysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe