Clinical trial NCT00974948: Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inoperable, Painful Pancreatic Cancer
Keywords: Pancreatic cancer
Therapy
Neurolysis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 month, 3 months
Secondary outcomes:
measure: 2. Quality of life 3. Survival
timeFrame: 1 month, 3 months and until death
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: CHUM, Universite de Montreal
name: Anand Sahai, MD
role: STUDY_DIRECTOR
References: