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.

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

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.

• The sample was composed of 98 patients.
• Mean patient age was 66.6 years.
• Of all patients, 52% were female and 48% were male.
• 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.

• Single site
• Outpatient
• Canada

Double-blind randomized controlled trial

• Numeric pain intensity rating scale 0–10
• Total morphine consumption
• Digestive Disease Quality-of-Life Questionnaire-15 (DDQ-15)

• 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).
• Change in morphine consumption was not different between groups at any time point.
• Authors noted no differences between groups in regard to survival or quality of life.
• Secondary analysis related to patients who received chemotherapy or radiation therapy.
  • 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).
  • 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.
  • In patients undergoing chemotherapy or radiation therapy, authors noted no difference between groups in morphine consumption.
  • In patients who did not have chemotherapy or radiation therapy, EUS-CPN patients had lower morphine consumption at three months (p = 0.05).

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. 

• The study had a small sample, with fewer than 100 patients.
• 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.
• Timing of pain intensity measures is not entirely clear. Whether pain measures represent least, average, and worst pain is unclear.
• Authors do not discuss breakthrough pain or its management.

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.