NCT00974948

Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis

A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic cancer presents with pain in the majority of cases. Destruction of the celiac ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used for pain that no longer responds to treatment with narcotics. The investigators compare standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective than narcotics and prevents escalating narcotic use.

Detailed description

This is a randomized, double blind, sham-controlled trial designed to evaluate the efficacy of early EUS-guided celiac plexus neurolysis (EUS-CPN). "Early" refers to the fact that, in contrast to previous CPN trials, we targeted patients with inoperable, painful pancreatic cancer in whom pain was mild and who were taking little or no narcotics. Our a priori hypotheses were that, compared to conventional management with narcotics alone, early neurolysis: 1) will better control pain related to inoperable pancreatic cancer, 2) will prevent the escalating use of narcotics associated with disease progression, 3) will improve quality of life, and 4) will improve survival. The aim our study is to test these 4 hypotheses.

Conditions

• Inoperable, Painful Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	EUS-guided celiac plexus neurolysis	Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2009-09-11
• Last updated: 2009-09-11

Locations

1 site across 1 country: Canada