A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer
Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United
States and is usually fatal. Surgery provides the only chance for long-term survival. Pain
is a significant, often difficult to control component of survivorship for many who succumb
to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac
plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for
pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a
prospective randomized double blind placebo controlled clinical trial.
This protocol is designed to definitively determine the role of ethanol celiac plexus
neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and
help define the standard of care for cancer associated pain management in this disease.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary endpoint is cancer related pain control.
Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors
Harish Lavu, MD
Thomas Jefferson University
United States: Institutional Review Board
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|