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

NCT ID: NCT00974948

Last Updated: 2009-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Inoperable, Painful Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neurolysis

Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.

Group Type: ACTIVE_COMPARATOR

EUS-guided celiac plexus neurolysis

Intervention Type: PROCEDURE

Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.

Conventional therapy

EUS will be performed with no celiac plexus neurolysis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EUS-guided celiac plexus neurolysis

Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

CHUM, Universite de Montreal

Principal Investigators

Anand Sahai, MD

Role: STUDY_DIRECTOR

CHUM, Universite de Montreal

Locations

CHUM

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ND05.083

Identifier Type: -

Identifier Source: org_study_id