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EUS Guided Celiac Neurolysis

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Michael Levy, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01615653
First received: April 17, 2012
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

  • Hypothesis:

    - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.

  • Rationale:

    • Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

Condition Intervention Phase
Pancreatic Cancer Pain
 Procedure: EUS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pain assessed using a numerical rating scale (NRS) from 0 to 10. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    pain response will be measured


Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS 1 Procedure: EUS
EUS Guided Therapy
Active Comparator: EUS 2 Procedure: EUS
EUS Guided Therapy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  • 2. Cytologic or histologic confirmation of pancreatic carcinoma
  • 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  • 4. EUS clinically indicated (for non-study purposes)

Exclusion Criteria:

  • 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  • 2. Abdominal surgery within 1 month
  • 3. Prior celiac plexus or ganglia neurolysis.
  • 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  • 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615653

Contacts
Contact: Michael J Levy, MD 507-266-6931 levy.michael@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55906
Contact: Michael J Levy, MD     507-266-6931     levy.michael@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
American College of Gastroenterology
  More Information

No publications provided

Responsible Party: Michael Levy, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01615653     History of Changes
Other Study ID Numbers: 09-005037
Study First Received: April 17, 2012
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pancreatic cancer
Pancreas cancer
Pain
Celiac Plexus
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

ClinicalTrials.gov processed this record on May 23, 2013