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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Completed; Phase 3

Conditions: Inoperable, Painful Pancreatic Cancer

Treatments: Procedure: EUS-guided celiac plexus neurolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00974948

ND05.083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Neurolysis

Active Comparator group

Description:

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

Treatment:

Procedure: EUS-guided celiac plexus neurolysis

Conventional therapy

No Intervention group

Description:

EUS will be performed with no celiac plexus neurolysis.