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2017-04-24
2018-04-01
2018-08-01
28
NCT03152487
AdventHealth
AdventHealth
INTERVENTIONAL
Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-20 | N/A | 2019-02-08 |
2017-05-12 | N/A | 2019-02-11 |
2017-05-15 | N/A | 2019-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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 arte | OTHER: Celiac Plexus Neurolysis
|
| 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. Ra | OTHER: Radiofrequency Ablation
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | Baseline to 4 week follow up |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) | 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. | 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). | 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 | 48 hours post procedure; 2 week follow up; 4 week follow up |
| Survival rate | Information regarding if the subject is alive or deceased. | 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. | Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
