Randomized Trial of EUS Neurolysis in Pancreas Cancer

Completed · Phase 3

Conditions studied: Pancreatic Neoplasms

In brief

This is a clinical trial to determine more effective methods of controlling the pain in pancreatic cancer. Although narcotic pain medication are effective, they have many side effects and are underutilized due to social stigma and fear of addiction. Celiac plexus neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be more effective and have fewer side effects than pain medication alone. We are evaluating the effectiveness of this standard pain medications with or without celiac plexus neurolysis in a randomized controlled trial. One half of the participants will receive pain medications only and the other half will receive pain medications plus neurolysis, delivered via an endoscopic ultrasound device placed in the stomach.

Key facts

Study ID

NCT00279292

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

26

Starts

2004-08-01

Expected to finish

2007-01-01

Last updated by the study team

2015-10-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.
• 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.
• 4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation >90%.
• 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.
• 8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.
• 9 Life expectancy > 3 months 3.10 Signed and dated informed consent.

You may not qualify if…

• Unable to sign informed consent

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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