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

Authors

• Harish Lavu
• Harry B Lengel
• Naomi M Sell
• Joseph A Baiocco
• Eugene P Kennedy
• Theresa P Yeo
• Sherry A Burrell
• Jordan M Winter
• Sarah Hegarty
• Benjamin E Leiby
• Charles J Yeo

Publication/Presentation Date

4-1-2015

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.

Volume

220

Issue

4

First Page

497

Last Page

508

ISSN

1879-1190

Published In/Presented At

Lavu, H., Lengel, H. B., Sell, N. M., Baiocco, J. A., Kennedy, E. P., Yeo, T. P., Burrell, S. A., Winter, J. M., Hegarty, S., Leiby, B. E., & Yeo, C. J. (2015). A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. Journal of the American College of Surgeons, 220(4), 497–508. https://doi.org/10.1016/j.jamcollsurg.2014.12.013

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

25667135

Department(s)

Administration and Leadership

Document Type

Article