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

Phase 3

Completed

• Conditions: Inoperable, Painful Pancreatic Cancer
• Interventions: Procedure: EUS-guided celiac plexus neurolysis

• Registration Number: NCT00974948
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Last Update Submitted: 2009-09-10
• Study First Posted: 2009-09-11
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• previous imaging and/or the EUS examination demonstrated inoperable pancreatic cancer defined as involvement of the superior mesenteric vein, portal vein or confluence, superior mesenteric artery, celiac axis, hepatic artery, or non-regional lymphadenopathy
• a new diagnosis of pancreatic adenocarcinoma was confirmed by an on-site cytopathologist following EUS fine needle aspiration (EUS-FNA)

Exclusion Criteria

• allergy to bupivicaine
• possible future surgical management of the tumor
• expected survival less than 3months (suspected or proven carcinomatosis or liver metastases)
• inability or unwillingness to provide informed consent prior to the EUS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurolysis	EUS-guided celiac plexus neurolysis	Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.

Primary Outcome Measures

Name	Time	Method
Absolute and relative changes in 7-point Likert-score for abdominal pain at 1 and 3 months post-randomization. Secondary endpoints were change in morphine equivalent consumption (MEQ), quality of life (DDQ-15), and overall survival.	1 month, 3 months

Secondary Outcome Measures

Name	Time	Method
2. Quality of life 3. Survival	1 month, 3 months and until death

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montreal, Quebec, Canada