A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma

J Am Coll Surg. 2015 Apr;220(4):497-508. doi: 10.1016/j.jamcollsurg.2014.12.013. Epub 2014 Dec 17.

Abstract

Background: Ethanol celiac plexus neurolysis (ECPN) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma (PPA). This study examined its efficacy in patients undergoing PPA resection.

Study design: There were 485 patients who participated in this prospective, randomized, double-blind placebo controlled trial. Patients were stratified by preoperative pain and disease resectability. They received either ECPN (50% ethanol) or 0.9% normal saline placebo control. The primary endpoint was short- and long-term pain and secondary endpoints included postoperative morbidity, quality of life, and overall survival.

Results: Data from 467 patients were analyzed. The primary endpoint, the percentage of PPA patients experiencing a worsening of pain compared with preoperative baseline for resectable patients, was not different between the ethanol and saline groups in either the resectable/pain stratum (22% vs 18%, relative risk [RR] 1.23 [0.34, 4.46]), or the resectable/no pain stratum (37% vs 34%, RR 1.10 [0.67, 1.81]). In multivariable analysis of resected pancreatic ductal adenocarcinoma (PDA) patients, there was a significant reduction in pain in the resectable/pain group, suggesting that surgical resection of the malignancy alone (independent of ECPN) decreases pain to a significant degree.

Conclusions: In this study, we demonstrated a significant reduction in pain after surgical resection of PPA. However, the addition of ECPN did not synergize to result in a further reduction in pain, and in fact, its effect may have been masked by surgical resection. Given this, we cannot recommend the use of ECPN to mitigate cancer-related pain in resectable PPA patients.

Trial registration: ClinicalTrials.gov NCT00806611.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Abdominal Pain / diagnosis
  • Abdominal Pain / etiology
  • Abdominal Pain / therapy*
  • Adenocarcinoma / complications
  • Adenocarcinoma / mortality
  • Adenocarcinoma / surgery*
  • Aged
  • Autonomic Nerve Block / methods*
  • Celiac Plexus / drug effects*
  • Double-Blind Method
  • Ethanol / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Pancreatectomy*
  • Pancreatic Neoplasms / complications
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / surgery*
  • Pennsylvania / epidemiology
  • Prospective Studies
  • Survival Rate / trends
  • Treatment Outcome

Substances

  • Ethanol

Associated data

  • ClinicalTrials.gov/NCT00806611