Randomized Trial of EUS Neurolysis in Pancreas Cancer
Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain
2 other identifiers
interventional
26
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedOctober 14, 2015
October 1, 2015
2.4 years
January 17, 2006
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the efficacy of treatment of ethanol injection versus placebo
injection for pain in pancreatic cancer patients at 1 month and 3 months.
Secondary Outcomes (4)
To evaluate mortality and surgical morbidity at 1 month and 3 months
To evaluate magnitude of narcotic use after treatment at 1 month and 3 months
To estimate the period of time pain scores will remain below baseline levels
To estimate the effect of treatment on quality of life at 1 month and 3 month
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.
- 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.
- Patient must not require more than 2 l/min oxygen supplementation to maintain saturation \>90%.
- \> 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.
- Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.
- Life expectancy \> 3 months 3.10 Signed and dated informed consent.
You may not qualify if:
- Unable to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Wallace, MD MPH
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
August 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
October 14, 2015
Record last verified: 2015-10