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Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain


Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain


This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided
celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have
significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic
ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same
medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine
and ethanol. Patients will be followed for at least 3 months for pain, quality of life and
narcotic usage.


Inclusion Criteria:



3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical
comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive
portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual)
will be included only if the consulting surgeon feels the patients is unresectable based
on the CT scan information.

3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at
least 1 hour per day.

3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not
required unless clinically indicated due to known warfarin use or suspected coagulopathy.

3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain
saturation >90%.

3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since
previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7
days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy
and radiotherapy allowances.

3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to
known or suspected coagulopathy.

3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent.

Exclusion Criteria:

Unable to sign informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of treatment of ethanol injection versus placebo

Principal Investigator

Michael B Wallace, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

R03 DK69947 (completed)

NCT ID:

NCT00279292

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic neoplasm
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic JacksonvilleJacksonville, Florida  32224