A Prospective, Randomized, Double-Blind, Placebo Controlled Trial on the Efficacy of Ethanol Celiac Plexus Neurolysis in Patients with Operable Pancreatic and Periampullary Adenocarcinoma - 23/03/15

Doi : 10.1016/j.jamcollsurg.2014.12.013

Harish Lavu, MD, FACS ^a,^⁎ , Harry B. Lengel, BA ^a, Naomi M. Sell, BA ^a, Joseph A. Baiocco, BS ^a, Eugene P. Kennedy, MD, FACS ^a, Theresa P. Yeo, PhD ^a, Sherry A. Burrell, PhD ^c, Jordan M. Winter, MD, FACS ^a, Sarah Hegarty, MPhil ^b, Benjamin E. Leiby, PhD ^b, Charles J. Yeo, MD, FACS ^a
^a Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA
^b Division of Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA
^c School of Nursing, Rutgers University, The State University of New Jersey, Camden, NJ

^∗Correspondence address: Harish Lavu, MD, FACS, Thomas Jefferson University, 1025 Walnut St, Suite 605, Philadelphia, PA, 19107.

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.

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Abbreviations and Acronyms : BPI, ECPN, PDA, PPA, QOL, R/NP, R/P, RR, UR/NP, UR/P

Plan

Primary outcome: Worsening of baseline pain

Secondary outcomes: Quality of life and overall survival

Discussion

Conclusions

Author Contributions

	Disclosure Information: Nothing to disclose.
	Support: Statistical analysis funded by the Kimmel Cancer Center core grant (5 P30 CA056036-10 and 5 P30 CA056036-16). ClinicalTrials.gov number, NCT00806611.