Randomized phase II study of the anti-inflammatory effect of ghrelin during the postoperative period of esophagectomy

Annals of Surgery

Volumn 262, Issue 2, 2015, Pages 230-236

  Takata, Akihiro ^a   Takiguchi, Shuji ^a   Miyazaki, Yasuhiro ^a   Miyata, Hiroshi ^a   Takahashi, Tsuyoshi ^a   Kurokawa, Yukinori ^a   Yamasaki, Makoto ^a   Nakajima, Kiyokazu ^a   Mori, Masaki ^a   Kangawa, Kenji ^b   Doki, Yuichiro ^a  

^a School of Medicine   (Japan)

^b NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

Author keywords

esophagectomy; ghrelin; systemic inflammatory response syndrome (SIRS)

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; C REACTIVE PROTEIN; CHOLINESTERASE; CISPLATIN; CREATININE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; GHRELIN; GROWTH HORMONE; INTERLEUKIN 6; IRINOTECAN; METHYLPREDNISOLONE; PLACEBO; RETINOL BINDING PROTEIN; SODIUM CHLORIDE;

ADULT; AGED; ANASTOMOSIS LEAKAGE; ANTIINFLAMMATORY ACTIVITY; ARTICLE; ATELECTASIS; BLOOD ANALYSIS; BODY COMPOSITION; BODY WEIGHT; CANCER ADJUVANT THERAPY; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONTINUOUS INFUSION; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; ESOPHAGUS CANCER; ESOPHAGUS RESECTION; FEMALE; HEART ARRHYTHMIA; HUMAN; INCIDENCE; LEAN BODY WEIGHT; MALE; MANAGED CARE; NITROGEN BALANCE; NUTRITIONAL STATUS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; POSTOPERATIVE COMPLICATION; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE INFLAMMATION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RECURRENT LARYNGEAL NERVE PALSY; SURGICAL TECHNIQUE; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; TIME TO TREATMENT; TREATMENT DURATION; WOUND INFECTION; ADVERSE EFFECTS; BLOOD; CLINICAL TRIAL; ESOPHAGEAL NEOPLASMS; FOLLOW UP; METABOLISM; MIDDLE AGED; PATHOLOGY;

AGED; C-REACTIVE PROTEIN; ESOPHAGEAL NEOPLASMS; ESOPHAGECTOMY; FEMALE; FOLLOW-UP STUDIES; GHRELIN; HUMANS; INCIDENCE; INTERLEUKIN-6; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME;

EID: 84938290876     PISSN: 00034932     EISSN: 15281140     Source Type: Journal    
DOI: 10.1097/SLA.0000000000000986     Document Type: Article

References (53)

1. Enzinger PC, Mayer RJ,. Esophageal cancer. N Engl J Med. 2003; 349: 2241-2252
2. Sjoquist KM, Burmeister BH, Smithers BM, Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-Analysis. Lancet Oncol. 2011; 12: 681-692
3. Kawahara Y, Ninomiya I, Fujimura T, Prospective randomized controlled study on the effects of perioperative administration of a neutrophil elastase inhibitor to patients undergoing video-Assisted thoracoscopic surgery for thoracic esophageal cancer. Dis Esophagus. 2010; 23: 329-339
4. Morita M, Yoshida R, Ikeda K, Acute lung injury following an esophagectomy for esophageal cancer, with special reference to the clinical factors and cytokine levels of peripheral blood and pleural drainage fluid. Dis Esophagus. 2008; 21: 30-36
5. Derogar M, Orsini N, Sadr-Azodi O, Influence of major postoperative complications on health-related quality of life among long-Term survivors of esophageal cancer surgery. J Clin Oncol. 2012; 30: 1615-1619
6. Hirai T, Yamashita Y, Mukaida H, Poor prognosis in esophageal cancer patients with postoperative complications. Surg Today. 1998; 28: 576-579
7. Opal SM, Fisher CJ Jr, Dhainaut JF, Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group. Crit Care Med. 1997; 25: 1115-1124
8. Akamoto S, Okano K, Sano T, Neutrophil elastase inhibitor (sivelestat) preserves antitumor immunity and reduces the inflammatory mediators associated with major surgery. Surg Today. 2007; 37: 359-365
9. Ryugo M, Sawa Y, Takano H, Effect of a polymorphonuclear elastase inhibitor (sivelestat sodium) on acute lung injury after cardiopulmonary bypass: findings of a double-blind randomized study. Surg Today. 2006; 36: 321-326
10. Sato A, Kuwabara Y, Shinoda N, Use of low dose dopamine, gabexate mesilate and ulinastatin reduces the water balance and pulmonary complication in thoracic esophagectomy patients. Dis Esophagus. 2005; 18: 151-154
11. Ono S, Aosasa S, Mochizuki H,. Effects of a protease inhibitor on reduction of surgical stress in esophagectomy. Am J Surg. 1999; 177: 78-82
12. Sato N, Koeda K, Ikeda K, Randomized study of the benefits of preoperative corticosteroid administration on the postoperative morbidity and cytokine response in patients undergoing surgery for esophageal cancer. Ann Surg. 2002; 236: 184-190
13. Shimada H, Ochiai T, Okazumi S, Clinical benefits of steroid therapy on surgical stress in patients with esophageal cancer. Surgery. 2000; 128: 791-798
14. Tsukada K, Miyazaki T, Katoh H, Effect of perioperative steroid therapy on the postoperative course of patients with oesophageal cancer. Dig Liver Dis. 2006; 38: 240-244
15. Shintani M, Ogawa Y, Ebihara K, Ghrelin, an endogenous growth hormone secretagogue, is a novel orexigenic peptide that antagonizes leptin action through the activation of hypothalamic neuropeptide Y/Y1 receptor pathway. Diabetes. 2001; 50: 227-232
16. Masuda Y, Tanaka T, Inomata N, Ghrelin stimulates gastric acid secretion and motility in rats. Biochem Biophys Res Commun 2000; 276: 905-908
17. Nagaya N, Moriya J, Yasumura Y, Effects of ghrelin administration on left ventricular function, exercise capacity, and muscle wasting in patients with chronic heart failure. Circulation. 2004; 110: 3674-3679
18. Nagaya N, Itoh T, Murakami S, Treatment of cachexia with ghrelin in patients with COPD. Chest. 2005; 128: 1187-1193
19. Strasser F, Lutz TA, Maeder MT, Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study. Br J Cancer. 2008; 98: 300-308
20. Adachi S, Takiguchi S, Okada K, Effects of ghrelin administration after total gastrectomy: a prospective, randomized, placebo-controlled phase II study. Gastroenterology. 2010; 138: 1312-1320
21. Yamamoto K, Takiguchi S, Miyata H, Randomized phase II study of clinical effects of ghrelin after esophagectomy with gastric tube reconstruction. Surgery. 2010; 148: 31-38
22. Hiura Y, Takiguchi S, Yamamoto K, Effects of ghrelin administration during chemotherapy with advanced esophageal cancer patients: a prospective, randomized, placebo-controlled phase 2 study. Cancer. 2012; 118: 4785-4794
23. Wu R, Dong W, Zhou M, Ghrelin attenuates sepsis-induced acute lung injury and mortality in rats. Am J Respir Crit Care Med. 2007; 176: 805-813
24. Doki Y, Takachi K, Ishikawa O, Ghrelin reduction after esophageal substitution and its correlation to postoperative body weight loss in esophageal cancer patients. Surgery. 2006; 139: 797-805
25. Yamamoto K, Takiguchi S, Miyata H, Reduced plasma ghrelin levels on day 1 after esophagectomy: a new predictor of prolonged systemic inflammatory response syndrome. Surg Today. 2013; 43: 48-54
26. Tomimaru Y, Yano M, Takachi K, Factors affecting the prognosis of patients with esophageal cancer undergoing salvage surgery after definitive chemoradiotherapy. J Surg Oncol. 2006; 93: 422-428
27. Sobin LH, Gospodawowics MK, Wittekind C H, eds. TNM Classification of Malignant Tumors, 7th edition. New York, NY: Wiley-Liss, Inc; 2009
28. Ando N, Kato H, Igaki H, A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907). Ann Surg Oncol. 2012; 19: 68-74
29. Osugi H, Takemura M, Higashino M, Video-Assisted thoracoscopic esophagectomy and radical lymph node dissection for esophageal cancer A series of 75 cases. Surg Endosc. 2002; 16: 1588-1593
30. Shiozaki H, Yano M, Tsujinaka T, Lymph node metastasis along the recurrent nerve chain is an indication for cervical lymph node dissection in thoracic esophageal cancer. Dis Esophagus. 2001; 14: 191-196
31. Yamasaki M, Miyata H, Fujiwara Y, Minimally invasive esophagectomy for esophageal cancer: comparative analysis of open and hand-Assisted laparoscopic abdominal lymphadenectomy with gastric conduit reconstruction. J Surg Oncol. 2011; 104: 623-628
32. Muckart DJ, Bhagwanjee S,. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definitions of the systemic inflammatory response syndrome and allied disorders in relation to critically injured patients. Crit Care Med. 1997; 25: 1789-1795
33. Dindo D, Demartines N, Clavien PA,. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240: 205-213
34. Akamizu T, Shinomiya T, Irako T, Separate measurement of plasma levels of acylated and desacyl ghrelin in healthy subjects using a new direct ELISA assay. J Clin Endocrinol Metab. 2005; 90: 6-9
35. Mazess RB, Barden HS, Bisek JP, Dual-energy x-ray absorptiometry for total-body and regional bone-mineral and soft-Tissue composition. Am J Clin Nutr. 1990; 51: 1106-1112
36. Shimakawa T, Naritaka Y, Asaka S, Neoadjuvant chemotherapy (FAP) for advanced esophageal cancer. Anticancer Res. 2008; 28: 2321-2326
37. Yamasaki M, Miyata H, Tanaka K, Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus. Oncology. 2011; 80: 307-313
38. Daly JM, Fry WA, Little AG, Esophageal cancer: results of an American College of Surgeons Patient Care Evaluation Study. J Am Coll Surg. 2000; 190: 562-572; discussion 572-573
39. Viklund P, Lindblad M, Lu M, Risk factors for complications after esophageal cancer resection: a prospective population-based study in Sweden. Ann Surg. 2006; 243: 204-211
40. Sakamoto K, Arakawa H, Mita S, Elevation of circulating interleukin 6 after surgery: factors influencing the serum level. Cytokine. 1994; 6: 181-186
41. Sato N, Koeda K, Kimura Y, Cytokine profile of serum and bronchoalveolar lavage fluids following thoracic esophageal cancer surgery. Eur Surg Res. 2001; 33: 279-284
42. Li WG, Gavrila D, Liu X, Ghrelin inhibits proinflammatory responses and nuclear factor-kappaB activation in human endothelial cells. Circulation. 2004; 109: 2221-2226
43. Liu X, Xiao Q, Zhao K, Ghrelin inhibits high glucose-induced PC12 cell apoptosis by regulating TLR4/NF-kappaB pathway. Inflammation. 2013; 36: 1286-1294
44. Xu X, Jhun BS, Ha CH, Molecular mechanisms of ghrelin-mediated endothelial nitric oxide synthase activation. Endocrinology. 2008; 149: 4183-4192
45. Konturek PC, Brzozowski T, Engel M, Ghrelin ameliorates colonic inflammation. Role of nitric oxide and sensory nerves. J Physiol Pharmacol. 2009; 60: 41-47
46. Wang W, Bansal S, Falk S, Ghrelin protects mice against endotoxemia-induced acute kidney injury. Am J Physiol Renal Physiol. 2009; 297: F1032-F1037
47. Wu R, Dong W, Zhou M, Ghrelin improves tissue perfusion in severe sepsis via downregulation of endothelin-1. Cardiovasc Res. 2005; 68: 318-326
48. Li Y, Hai J, Li L, Administration of ghrelin improves inflammation, oxidative stress, and apoptosis during and after nonalcoholic fatty liver disease development. Endocrine. 2013; 43: 376-386
49. Zhang H, Cui Z, Luo G, Ghrelin attenuates intestinal ischemia/reperfusion injury in mice by activating the mTOR signaling pathway. Int J Mol Med. 2013; 32: 851-859
50. Vila G, Maier C, Riedl M, Bacterial endotoxin induces biphasic changes in plasma ghrelin in healthy humans. J Clin Endocrinol Metab. 2007; 92: 3930-3934
51. Koch A, Sanson E, Helm A, Regulation and prognostic relevance of serum ghrelin concentrations in critical illness and sepsis. Crit Care. 2010; 14: R94
52. Miki K, Maekura R, Nagaya N, Ghrelin treatment of cachectic patients with chronic obstructive pulmonary disease: a multicenter, randomized, double-blind, placebo-controlled trial. PLoS One. 2012; 7: e35708
53. Kodama T, Ashitani J, Matsumoto N, Ghrelin treatment suppresses neutrophil-dominant inflammation in airways of patients with chronic respiratory infection. Pulm Pharmacol Ther. 2008; 21: 774-779