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

ABSTRACT: 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.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.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.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.

SUBMITTER: Lavu H

PROVIDER: S-EPMC4448126 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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

Lavu Harish H Lengel Harry B HB Sell Naomi M NM Baiocco Joseph A JA Kennedy Eugene P EP Yeo Theresa P TP Burrell Sherry A SA Winter Jordan M JM Hegarty Sarah S Leiby Benjamin E BE Yeo Charles J CJ

Journal of the American College of Surgeons 20141217 4

<h4>Background</h4>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.<h4>Study design</h4>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 ei ...[more]

PMID: 25667135

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Project description:Background/Aims:In most instances of abdominal pain associated with pancreatic cancer, pain may become refractory to increasing doses of narcotics. Celiac plexus neurolysis represents an option; however, altered celiac plexus anatomy may render this treatment infeasible or ineffective, where splanchnic nerve neurolysis may represent another option. This study aimed to investigate the outcomes of splanchnic neurolysis in pancreatic cancer patients not responsive to celiac plexus neurolysis. Patients and Methods:Among all 84 patients who underwent celiac plexus neurolysis for pancreatic cancer pain during the study period, 34 patients did not respond and underwent splanchnic nerve neurolysis under fluoroscopic guidance and thus included in this retrospective study. Stage IV, III, and II disease was present in 38.2%, 47.1%, and 14.7% of the patients. During the study, 88.2% were receiving chemotherapy, whereas none were on radiotherapy. Data for daily narcotic dose equivalents and Visual Analogue Scale (VAS) scores during outpatient visits at baseline, 2 weeks, 2 months, and 3 months were extracted. Results:Pain response rates were 76.5%, 84.4%, and 71.0%, at 2 weeks, 2 months, and 3 months, respectively. A significant and dramatic reduction was seen in VAS scores at 2 weeks (2.8±1.2 versus 6.3±1.1, p<0.001), and this significant decline was maintained for 3 months. Similarly, a significant and dramatic reduction was seen in daily narcotic need at 2 weeks (20.8±32.9 versus 93.4±86.2 mg, p<0.001), which was also maintained during the 3-month follow-up. The procedure was generally well tolerated. Conclusion:Findings of this study suggest that splanchnic neurolysis represents a durable and effective option for pain control in pancreatic cancer patients in whom the neurolysis of the celiac plexus is ineffective. However, these conclusions refer to only preliminary single-center results in a selected patient group; thus, further large studies are warranted.

Project description:BackgroundComputerized tomography-guided celiac plexus neurolysis has become almost a safe technique to alleviate abdominal malignancy pain. We compared the single needle technique with changing patients' position and the double needle technique using posterior anterocrural approach.MethodsIn Double Needles Celiac Neurolysis Group (n = 17), we used two needles posterior anterocrural technique injecting 12.5 mL phenol 10% on each side in prone position. In Single Needle Celiac Neurolysis Group (n = 17), we used single needle posterior anterocrural approach. 25 mL of phenol 10% was injected from left side while patients were in left lateral position then turned to right side. The monitoring parameters were failure block rate and duration of patient positioning, technique time, Visual Analog Scale, complications (hypotension, diarrhea, vomiting, hemorrhage, neurological damage and infection) and rescue analgesia.ResultsThe failure block rate and duration of patient positioning significantly increased in double needles celiac neurolysis vs. single needle celiac neurolysis (30.8% vs. 0.13.8±1.2 vs. 8.9 ± 1; p = 0.046, p ≤ 0.001 respectively). Also, the technique time increased significantly in double needles celiac neurolysis than single needle celiac neurolysis (24.5 ± 5.1 vs. 15.4 ± 1.8; p ≤ 0.001). No significant differences existed as regards visual analogue scale: double needles celiac neurolysis = 2 (0-5), 2 (0-4), 3 (0-6), 3 (2-6) and single needle celiac neurolysis = 3 (0-5), 2 (0-5), 2 (0-4), 4 (2-6) after 1 day, 1 week, 1 and 3 months respectively. However, visual analogue scale in each group reduced significantly compared with basal values (p ≤ 0.001). There were no statistically significant differences as regards rescue analgesia and complications (p > 0.05).ConclusionSingle needle celiac neurolysis with changing patients' position has less failure block rate, less procedure time, shorter duration of patient positioning than double needles celiac neurolysis in abdominal malignancy.

Dataset Information

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

Publications

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

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