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A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Preoperative imaging indicates possibility of resectable pancreatic cancer

- Intraoperative biopsy histologically confirming pancreatic adenocarcinoma

Exclusion Criteria:

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is cancer related pain control.

Outcome Time Frame:

Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors

Safety Issue:

No

Principal Investigator

Harish Lavu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

08D.380

NCT ID:

NCT00806611

Start Date:

September 2008

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • periampullary cancer
  • resectable
  • unresectable
  • celiac plexus neurolysis
  • surgery
  • Pancreatic Neoplasms

Name

Location

Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541