Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis
Completed · Not applicable
Conditions studied: Pancreatic Carcinoma Metastatic, Pancreatic Adenocarcinoma, Pancreatic Neoplasms, Pancreatic Cancer, Pancreatic Cancer, Adult
In brief
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.
Key facts
- Study ID
- NCT03152487
- Run by
- AdventHealth
- People needed
- 28
- Starts
- 2017-04-24
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2019-02-11
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 19 years
- The subject is capable of understanding and complying with protocol requirements.
- The subject is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
- Abdominal pain typical for pancreatic cancer
- Cross-sectional imaging findings consistent with pancreatic cancer
- Pancreatic cancer confirmed by EUS-FNA in patients referred for suspected pancreatic cancer OR Patients with known diagnosis of pancreatic cancer
- Inoperable pancreatic cancer as determined during EUS or prior CT
You may not qualify if…
- Age <19 years
- Unable to obtain consent for the procedure from the patient
- Unable to safely undergo EUS for any reason
- Irreversible coagulopathy (Prothrombin time > 18 secs, platelet count < 50,000/ml)
- Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy
- Another cause for abdominal pain such as pseudocyst, ulcer or other intraabdominal disorder
- 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.
Where it is running
- Center for Interventional Endoscopy - Florida Hospital — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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