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EUS Guided Celiac Neurolysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615653
First Posted: June 8, 2012
Last Update Posted: July 25, 2017
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.
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Michael Levy, Mayo Clinic
  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
Pancreatic Cancer Pain Procedure: EUS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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 Michael Levy, 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


Enrollment: 110
Actual Study Start Date: September 2009
Study Completion Date: June 2015
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT01615653


Locations
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
ClinicalTrials.gov Identifier: NCT01615653     History of Changes
Other Study ID Numbers: 09-005037
First Submitted: April 17, 2012
First Posted: June 8, 2012
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Michael Levy, Mayo Clinic:
Pancreatic cancer
Pancreas cancer
Pain
Celiac Plexus
Neurolysis

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cancer Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms