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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974948
First Posted: September 11, 2009
Last Update Posted: September 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre hospitalier de l'Université de Montréal (CHUM)
  Purpose
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.

Condition Intervention Phase
Inoperable, Painful Pancreatic Cancer Procedure: EUS-guided celiac plexus neurolysis Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 2. Quality of life 3. Survival [ Time Frame: 1 month, 3 months and until death ]

Enrollment: 100
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neurolysis
Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.
Procedure: EUS-guided celiac plexus neurolysis
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
No Intervention: Conventional therapy
EUS will be performed with no celiac plexus neurolysis.

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974948


Locations
Canada, Quebec
CHUM
Montreal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Study Director: Anand Sahai, MD CHUM, Universite de Montreal
  More Information

Responsible Party: Anand Sahai MD, MSc (Epid), FRCPC, CHUM, Universite de Montreal
ClinicalTrials.gov Identifier: NCT00974948     History of Changes
Other Study ID Numbers: ND05.083
First Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Pancreatic cancer
Therapy
Neurolysis

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases