Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Procedure: Alcohol Block

Study type: Interventional

Funder types: Other

Identifiers

NCT00806611

JT 1239 (Other Identifier)

2007-32 (Other Identifier)

08D.380

Details and patient eligibility

About

Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain

Full description

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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preoperative imaging indicates possibility of resectable pancreatic cancer
• Intraoperative biopsy histologically confirming pancreatic adenocarcinoma

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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438 participants in 2 patient groups, including a placebo group

50% Ethanol

Experimental group

Description:

Operating surgeon injects 20 ml of 50% ethanol on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle

Treatment:

Procedure: Alcohol Block

Placebo

Placebo Comparator group

Description:

Operating surgeon injects 20 ml of saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle

Treatment:

Procedure: Alcohol Block