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

Inoperable, Painful Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974948
• Other study ID #: ND05.083
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: September 10, 2009
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Inoperable, Painful Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• EUS-guided celiac plexus neurolysis
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	2. Quality of life 3. Survival		1 month, 3 months and until death	No