Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer

The Australian Immunonutrition Study Group

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3 Citations (Scopus)

Abstract

Background: Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. Methods: Patients were randomized before oesophagectomy to immunonutrition (IMPACT®) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. Results: Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. Conclusion: Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 (https://www.anzctr.org.au).

Original languageEnglish
Pages (from-to)1262-1272
Number of pages11
JournalBritish Journal of Surgery
Volume105
Issue number10
DOIs
Publication statusPublished - 1 Sep 2018

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Esophageal Neoplasms
Randomized Controlled Trials
Esophagectomy
Quality of Life
Length of Stay
Nutritive Value
Hospital Mortality
Neoplasms
Research Personnel
Organizations
Incidence
Research

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@article{5b656997060349e9ad7fd814e6526c2b,
title = "Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer",
abstract = "Background: Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. Methods: Patients were randomized before oesophagectomy to immunonutrition (IMPACT{\circledR}) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. Results: Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. Conclusion: Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 (https://www.anzctr.org.au).",
author = "{The Australian Immunonutrition Study Group} and Mudge, {L. A.} and Watson, {D. I.} and Smithers, {B. M.} and Isenring, {E. A.} and L. Smith and Jamieson, {G. G.} and A. Aly and S. Archer and M. Ballal and J. Barbon and A. Barbour and K. Benton and J. Bessell and M. Bond and Melissa Berryman and T. Bright and R. Cade and A. Cardamis and R. Carroll and K. Cashman and L. Chan and B. Chapman and S. Chapman and D. Chen and J. Chisholm and W. Davidson and P. Devitt and C. Dong and R. Doola and S. Edwards and K. Epari and M. Farley and J. Farrow and M. Ferguson and D. Fletcher and K. Forbes and K. Fullerton and P. Game and S. Gan and D. Gotley and B. Gout and J. Gray and S. Heaney and Johnson, {M. A.} and M. Johnstone and S. Kariyawasam and J. Karnon and A. Kelaart and L. Kellett and E. Kennedy and R. Krane and S. Lemass and R. Lindstrom-Sowman and J. Loeliger and A. Lord and John Ludbrook and C. McFarlane and M. McPhee and Ooi, {S. Y.X.} and L. Pearce and K. Pettigrew and E. Putrus and G. Rassias and A. Shanks and J. Shenfine and Smith, {E. L.} and J. Singleton and J. Spillane and L. Sputore and B. Steer and T. Sullivan and L. Teleni and D. Tolcher and J. Thomas and S. Thompson and T. Thorpe and C. Watterson and V. Wills and A. Wilton and K. Wright and T. Wright",
year = "2018",
month = "9",
day = "1",
doi = "10.1002/bjs.10923",
language = "English",
volume = "105",
pages = "1262--1272",
journal = "European Journal of Surgery, Acta Chirurgica",
issn = "0007-1323",
publisher = "John Wiley & Sons",
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}

Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer. / The Australian Immunonutrition Study Group.

In: British Journal of Surgery, Vol. 105, No. 10, 01.09.2018, p. 1262-1272.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer

AU - The Australian Immunonutrition Study Group

AU - Mudge, L. A.

AU - Watson, D. I.

AU - Smithers, B. M.

AU - Isenring, E. A.

AU - Smith, L.

AU - Jamieson, G. G.

AU - Aly, A.

AU - Archer, S.

AU - Ballal, M.

AU - Barbon, J.

AU - Barbour, A.

AU - Benton, K.

AU - Bessell, J.

AU - Bond, M.

AU - Berryman, Melissa

AU - Bright, T.

AU - Cade, R.

AU - Cardamis, A.

AU - Carroll, R.

AU - Cashman, K.

AU - Chan, L.

AU - Chapman, B.

AU - Chapman, S.

AU - Chen, D.

AU - Chisholm, J.

AU - Davidson, W.

AU - Devitt, P.

AU - Dong, C.

AU - Doola, R.

AU - Edwards, S.

AU - Epari, K.

AU - Farley, M.

AU - Farrow, J.

AU - Ferguson, M.

AU - Fletcher, D.

AU - Forbes, K.

AU - Fullerton, K.

AU - Game, P.

AU - Gan, S.

AU - Gotley, D.

AU - Gout, B.

AU - Gray, J.

AU - Heaney, S.

AU - Johnson, M. A.

AU - Johnstone, M.

AU - Kariyawasam, S.

AU - Karnon, J.

AU - Kelaart, A.

AU - Kellett, L.

AU - Kennedy, E.

AU - Krane, R.

AU - Lemass, S.

AU - Lindstrom-Sowman, R.

AU - Loeliger, J.

AU - Lord, A.

AU - Ludbrook, John

AU - McFarlane, C.

AU - McPhee, M.

AU - Ooi, S. Y.X.

AU - Pearce, L.

AU - Pettigrew, K.

AU - Putrus, E.

AU - Rassias, G.

AU - Shanks, A.

AU - Shenfine, J.

AU - Smith, E. L.

AU - Singleton, J.

AU - Spillane, J.

AU - Sputore, L.

AU - Steer, B.

AU - Sullivan, T.

AU - Teleni, L.

AU - Tolcher, D.

AU - Thomas, J.

AU - Thompson, S.

AU - Thorpe, T.

AU - Watterson, C.

AU - Wills, V.

AU - Wilton, A.

AU - Wright, K.

AU - Wright, T.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background: Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. Methods: Patients were randomized before oesophagectomy to immunonutrition (IMPACT®) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. Results: Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. Conclusion: Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 (https://www.anzctr.org.au).

AB - Background: Preoperative immunonutrition has been proposed to reduce the duration of hospital stay and infective complications following major elective surgery in patients with gastrointestinal malignancy. A multicentre 2 × 2 factorial RCT was conducted to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with oesophageal cancer. Methods: Patients were randomized before oesophagectomy to immunonutrition (IMPACT®) versus standard isocaloric/isonitrogenous nutrition, then further randomized after operation to immunonutrition versus standard nutrition. Clinical and quality-of-life outcomes were assessed at 14 and 42 days after operation on an intention-to-treat basis. The primary outcome was the occurrence of infective complications. Secondary outcomes were other complications, duration of hospital stay, mortality, nutritional and quality-of-life outcomes (EuroQol EQ-5D-3 L™, European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-OES18). Patients and investigators were blinded until the completion of data analysis. Results: Some 278 patients from 11 Australian sites were randomized; two were excluded and data from 276 were analysed. The incidence of infective complications was similar for all groups (37 per cent in perioperative standard nutrition group, 51 per cent in perioperative immunonutrition group, 34 per cent in preoperative immunonutrition group and 40 per cent in postoperative immunonutrition group; P = 0·187). There were no significant differences in any other clinical or quality-of-life outcomes. Conclusion: Use of immunonutrition before and/or after surgery provided no benefit over standard nutrition in patients undergoing oesophagectomy. Registration number: ACTRN12611000178943 (https://www.anzctr.org.au).

UR - http://www.scopus.com/inward/record.url?scp=85050476896&partnerID=8YFLogxK

U2 - 10.1002/bjs.10923

DO - 10.1002/bjs.10923

M3 - Article

VL - 105

SP - 1262

EP - 1272

JO - European Journal of Surgery, Acta Chirurgica

JF - European Journal of Surgery, Acta Chirurgica

SN - 0007-1323

IS - 10

ER -