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EUS Guided Celiac Neurolysis

This study is ongoing, but not recruiting participants.
American College of Gastroenterology
Information provided by (Responsible Party):
Michael Levy, Mayo Clinic Identifier:
First received: April 17, 2012
Last updated: August 18, 2015
Last verified: August 2015
  • 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
Pancreatic Cancer Pain
Procedure: EUS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

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 ]
    pain response will be measured

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2016
Primary Completion Date: March 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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01615653

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55906
Sponsors and Collaborators
Mayo Clinic
American College of Gastroenterology
  More Information

Responsible Party: Michael Levy, Professor of Medicine, Mayo Clinic Identifier: NCT01615653     History of Changes
Other Study ID Numbers: 09-005037
Study First Received: April 17, 2012
Last Updated: August 18, 2015

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases processed this record on April 28, 2017