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

This study has been completed.
Sponsor:
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00974948
First received: September 10, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 10, 2009
September 10, 2009
April 2006
December 2008   (final data collection date for primary outcome 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. [ Time Frame: 1 month, 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
2. Quality of life 3. Survival [ Time Frame: 1 month, 3 months and until death ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Inoperable, Painful Pancreatic Cancer
Procedure: EUS-guided celiac plexus neurolysis
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
  • Active Comparator: Neurolysis
    Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.
    Intervention: Procedure: EUS-guided celiac plexus neurolysis
  • No Intervention: Conventional therapy
    EUS will be performed with no celiac plexus neurolysis.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00974948
ND05.083
No
Anand Sahai MD, MSc (Epid), FRCPC, CHUM, Universite de Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
Not Provided
Study Director: Anand Sahai, MD CHUM, Universite de Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP