Wyse, J.M., Carone, M., Paquin, S.C., Usatii, M., & Sahai, A.V. (2011). Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 29(26), 3541–3546.
DOI Link
Study Purpose
To determine if early ultrasound-guided celiac plexus neurolysis (EUS-CPN) prevents pain progression in and reduces narcotic use by patients with painful inoperable pancreatic cancer
Intervention Characteristics/Basic Study Process
Eligible for the study were patients referred for endoscopic ultrasound for the diagnosis and staging of suspected pancreatic cancer with new onset of suspected cancer-related pain. If onsite cytopathology results confirmed the diagnosis of adenocarcinoma and the lesion was deemed inoperable, consenting patients were randomly assigned to EUS-CPN or no EUS-CPN. Celiac plexus neurolysis (CPN) was performed during the endoscopic procedure. After the procedure patients returned to the referring physician for ongoing pain management. One month after randomization, a patient could undergo open-label CPN at the physician’s discretion. Investigators assessed outcomes at one and three months after randomization.
Sample Characteristics
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The sample was composed of 98 patients.
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Mean patient age was 66.6 years.
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Of all patients, 52% were female and 48% were male.
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All patients had inoperable pancreatic cancer. Investigators performed subgroup analysis of patients who received chemotherapy and/or radiation therapy for pain management. On average, patients had a pain-duration history of nine weeks. Average pain intensity score at baseline was 4.7 on an 11-point scale.
Setting
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Single site
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Outpatient
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Canada
Study Design
Double-blind randomized controlled trial
Measurement Instruments/Methods
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Numeric pain intensity rating scale 0–10
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Total morphine consumption
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Digestive Disease Quality-of-Life Questionnaire-15 (DDQ-15)
Results
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Sixty patients survived to the three-month follow-up point. All subjects randomized were included in intention-to-treat analysis. Pain relief with EUS-CPN was greater at one month (mean difference [MD] of pain scores: –28.9, 95% CI –67 through –2.8, p = 0.09) and three months (MD: –60.7, 95% CI –86.6 through –25.5, p = 0.01). However, the difference in mean change from baseline was significantly lower in the EUS-CPN group after one month (p = 0.01) and three months (p < 0.001).
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Change in morphine consumption was not different between groups at any time point.
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Authors noted no differences between groups in regard to survival or quality of life.
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Secondary analysis related to patients who received chemotherapy or radiation therapy.
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Among patients who did not undergo chemotherapy or radiation therapy, EUS-CPN was associated with significantly better pain relief at one month and three months (p < 0.001).
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In patients who underwent chemotherapy or radiation therapy, pain control with EUS-CPN was not significantly different from pain control in patients who did not undergo EUS-CPN.
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In patients undergoing chemotherapy or radiation therapy, authors noted no difference between groups in morphine consumption.
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In patients who did not have chemotherapy or radiation therapy, EUS-CPN patients had lower morphine consumption at three months (p = 0.05).
Conclusions
Results show that, compared to pain management with narcotics alone, early EUS-CPN provides greater pain relief. In the sudied patients, this approach was not better than chemotherapy or radiation therapy for pain control.
Limitations
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The study had a small sample, with fewer than 100 patients.
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Pain intensity measures used for analysis are unclear. Methods describe use of an 11-point scale and analysis of percentage of change. However, results are reported as mean differences. Presumably the differences are differences in mean percentage of change, but that is not clear.
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Timing of pain intensity measures is not entirely clear. Whether pain measures represent least, average, and worst pain is unclear.
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Authors do not discuss breakthrough pain or its management.
Nursing Implications
For patients with painful inoperable pancreatic cancer, early EUS-CPN may provide better pain control than do opioids alone. However, this study does not show any difference in overall morphine consumption associated with EUS-CPN. In this group of patients, palliative chemotherapy or radiation therapy appears to achieve pain control similar to the pain control that EUS-CPN achieves. EUS-CPN has not been associated with early or late complications; it may produce fewer side effects and symptoms than chemotherapy or radiation therapy. For this group of patients, nurses can advocate for consideration of EUS-CPN for adjuvant pain management. The advantage of early EUS-CPN is that the procedure can be done at the same time as a staging procedure, limiting the number of invasive procedures that the patient has to undergo.