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

Autor:	Lavu H; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA. Electronic address: harish.lavu@jefferson.edu., Lengel HB; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Sell NM; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Baiocco JA; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Kennedy EP; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Yeo TP; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Burrell SA; School of Nursing, Rutgers University, The State University of New Jersey, Camden, NJ., Winter JM; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Hegarty S; Division of Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Leiby BE; Division of Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA., Yeo CJ; Department of Surgery, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA.
Jazyk:	angličtina
Zdroj:	Journal of the American College of Surgeons [J Am Coll Surg] 2015 Apr; Vol. 220 (4), pp. 497-508. Date of Electronic Publication: 2014 Dec 17.
DOI:	10.1016/j.jamcollsurg.2014.12.013
Abstrakt:	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. (Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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