Seicean, A., Cainap, C., Gulei, I., Tantau, M., & Seicean, R. (2013). Pain palliation by endoscopic ultrasound-guided celiac plexus neurolysis in patients with unresectable pancreatic cancer. Journal of Gastrointestinal and Liver Diseases, 22, 59–64.

Study Purpose

To evaluate the safety and initial efficacy of endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with painful unresectable pancreatic cancer

Intervention Characteristics/Basic Study Process

All patients enrolled in the study received the EUS-CPN procedure once. As per protocol, patients were placed in left lateral position under either general anesthesia with propofol or IV deep sedation with midazolam, according to the patient’s personal preference.  If the patient was found to have unresectable disease and the fine-gauge needle aspiration findings were consistent with pancreatic cancer, CPN was performed under EUS guidance.  All procedures were performed by a single endosonographer. The 22-gauge injection needle was inserted into the targeted central position, advanced to the celiac trunk, and injected bupivacaine 1% and then a single injection of 10–15 ml of absolute alcohol. Each patient was monitored closely for two hours post-procedure in order to identify any immediate complications such as hypotension, tachycardia, pain enhancement, or paraplegia. Each patient was called 48 hours post-procedure to monitor for late effects such as diarrhea, hypotension, fever, or paraplegia.

Sample Characteristics

  • N = 32  
  • AGE RANGE: 37–68 years
  • MEAN AGE: 56.93 years
  • MALES:  69%, FEMALES: 31%
  • KEY DISEASE CHARACTERISTICS: All had diagnosis of inoperable pancreatic body-tail cancer without prior chemotherapy and presented with pain that necessitated opioid analgesia.
  • OTHER KEY SAMPLE CHARACTERISTICS: Their visual analog scale (VAS) pain score was greater than 3 at the time of endoscopy, and diagnosis of pancreatic cancer was confirmed by cytopathological examination.

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: Romania

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Prospective cohort study of patients undergoing EUS-CPN for local advanced pancreatic adenocarcinoma without prior chemotherapy and pain requiring opioid analgesia
  • Conducted at a tertiary medical center

Measurement Instruments/Methods

  • Assessment of pain and quality of life
    • Before the procedure, the Brief Pain Inventory-Short Form (BPI-SF) and the Functional Assessment of Cancer Therapy-General (FACT-G) (version 4) were administered to each patient. The BPI-SF evaluates the presence of pain using a 0–10 VAS to report average pain, minimum and maximum pain, and response to painkillers over the seven-day period preceding the intervention. The BPI-SF also evaluated the relationship of pain to activities such as walking, working, sleeping, social relations, and enjoyment of life. The FACT-G questionnaire evaluated physical well-being, social/family well-being, emotional well-being, and functional well-being. Each patient’s present health status was evaluated by means of self-reported VAS (0–100).
  • Follow-up
    • Pain and quality of life were re-evaluated at the two-week follow-up visit (two weeks post-procedure). The BPI-SF and FACT-G were administered again, and any change in opioid daily usage was documented. Pain improvement was defined as a decrease of 2 or more points in pain score as compared to the index value without concurrent increase in oral opioid intake.

Results

Each participant had one session of EUS-CPN performed. No complications or side effects were noted. Overall, the average pain decreased by 2 or more points in 28 of 32 patients (87.5%). Physical, emotional, and functional well-being scores were improved after the procedure. Family and social support did not change after the procedure. Pain relief experienced with use of medication after the EUS-CPN intervention (90%) did not significantly increase compared to prior (80%). The rate of pain alleviation, defined as a decrease of 2 or more points in pain score, was 75% in short-term follow-up. All BPI-SF measures of effects of pain showed improvement after EUS-CPN, including walking, general activity, working, sleeping, and enjoyment of life.

The FACT-G quality of life questionnaire showed physical, functional, and emotional well-being improved after EUS-CPN, as well as subjective appreciation of life. Functional status, work capability, sleeping, and enjoyment of leisure activities improved. Difficulties in physical status such as lack of energy, poor physical condition, and feeling ill were improved. No differences were found in coping with the disease (i.e., hopefulness and satisfaction with one’s own behavior), acceptance of the disease, enjoyment of life, or fulfillment at work.

Conclusions

This study demonstrated that EUS-CPN provides a safe and effective method of short-term pain management in patients with inoperable pancreatic body-tail cancer. Diminishing pain resulted in improvements in the areas of functional status, sleeping, and quality of life. Acceptance of the illness and enjoyment of life did not change.

These results would have increased substantiation with further research that included longer-term follow-up as well as investigation into multiple doses with a control group for further comparison to determine more explicitly the results demonstrated here and the relational cues to the intervention (as opposed to simply having a different subjective experience at the date of the two-week follow-up visit).

Limitations

  • Small sample (less than 100)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Excluded patients receiving any cancer therapy other than painkillers

Nursing Implications

These findings present an area for further nursing attention and related research. With no adverse effect noted during or post-procedure, this presents an opportunity for further research to determine comparison of results when a control group is implemented, increased frequency/doses of the intervention, and follow-up that continues at similar intervals but for a longer time (as appropriate with increased exposure to the intervention at regular intervals).