Randomized Trial of EUS Neurolysis in Pancreas Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | August 2004 |
| End Date: | January 2007 |
Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain
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.
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.
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.
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
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