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

NCT03152487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-02-11

No results posted yet for this study

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.

Conditions

  • Pancreatic Carcinoma Metastatic
  • Pancreatic Adenocarcinoma
  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Pancreatic Cancer, Adult

Interventions

OTHER

Celiac Plexus Neurolysis

This intervention involves accessing the Celiac Plexus Nerve via endoscopic guided ultrasound and then injecting the nerve bundle with bupivacaine.

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.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Shyam S Varadarajulu, MD · AdventHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2018-04-01
Completion
2018-08-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152487 on ClinicalTrials.gov