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Colorectal Endoscopic Stenting Trial (CReST) for obstructing left-sided colorectal cancer: randomized clinical trial

医学 外科 内窥镜支架置入术 围手术期 随机对照试验 结直肠癌 随机化 造口(药) 减压 支架 癌症 内科学
作者
James E. Hill,S Lee,Dion Morton,M. C. Parker,Steve Halligan,Stuart A. Taylor,Catherine Kay,Richard Gray,Kelly Handley,Manjinder Kaur,Laura Magill,Letitia C. Fulcher,Manjinder Kaur,Helen Lilly,Alan Warwick Palmer,Anna Peters,Laura Magill,Chakanaka Sidile,Adrian Wilcockson,H Bensoussane,Kelly Handley,N Marchevsky,Alfred Oliver,Gordon L Carlson,Nigel Scott,Louise Hiller,Derek Alderson,D. F. Martin,Ly–Mee Yu,A Chokkalingam,Nicholas B Cross,Ray Delicata,Paul Edwards,Gregory M. Sturgeon,Diego Domingo,James L. Gutmann,Jinfeng Huang,Tina Mills-Baldock,A Mtwana,Purushothaman Premchand,Nicola Willis,Shirley Cocks,E Curran,Zara Gall,Pamela Jo Harris,J Hobbiss,George Lipscomb,A Maxwell,Heena Patel,David C. Smith,R M Antrum,Conrad Beckett,Justine Davies,T.S. Ghosh,Jay Gokhale,John P. Griffith,J Halstead,Christian S. Jackson,Sue Jowett,Catherine Kay,Andrew Lowe,James W. May,John E. McGowan,Jonathan Robinson,R Simpson,Sophie Stephenson,Mark Steward,B Thomas,Andrew Thrower,Karen Ward,Jason Dexter,Timothy E. Doyle,P A Farrands,Andrew Hart,Marc Lamah,Peterson Jc,Hannah Brown,Ewen Cameron,N. Carroll,Justine Davies,Nicola Fearnhead,K. Goodwin,Alexander D. Liddle,Rachel W. Miller,John M. Morton,Michael Powar,Deborah Read,Kirsten Sloan,J Uttridge,James M. Wheeler,I. M. Bain,Sue Clark,Jeremy Cundall,John Dent,S Green,N.D. Grunshaw,K. Gunning,A. E. Howey,Sarah Marsden,I. Minty,Laura Morgan,Sophie E. Noblett,Kyle Potts,John Scott,Deborah Turnbull,J. S. Varma,Laura L. Wayman,Sarah J. Welsh,Amy S. Anstead,R. Bhardwaj,Tracy Edmunds,Barry Fuller,P Holder,Linda Lacey,M. C. Parker,Ronan Ryan,J Smith-Hedges,C Stuart,Katherine Walsh,Alakananda Basu,Al Fazir Omar,J Pitt,G F Read,Paul Ridley,John H. Spurgeon,Y Tricker,Nigel C. Bird,David Browell,C Barry,William Cunliffe,M Eltringham,M Katrory,Mark Mercer-Jones,Colin Nice,John Scott,Grace Timmons,Matthew Leighton Williams,C Wipat,James D. Akula,Abby Caine,Peter Dawson,Gerhard Reese,Y Fatola,B Mazibuko,Mary M Pelling,Lorena Ramos,Geoff Smith,Kamal Aryal,Khaleel K. Ashraf,Rawya Badreldin,Bonnie E. Brett,Amila O. De Silva,Stuart R. Gray,John Harman,M Jordon,Kirosh Shankar Kshatriya,Roshan Lal,Luke A Perry,Vamsi Velchuru,Matthew Leighton Williams,Guy Carrault,Anika Hansmann,Andrew J M Leather,Savvas Papagrigoriadis,Praveen Peddu,Sara Ryan,Samuel S. Ambrose,R. P. Baker,D Beral,I. D. Botterill,Dermot Burke,Louise Clarke,M. D. Evans,Simon Everett,P. J. Finan,Ben Griffiths,John Hamlin,Julian Hance,Kelly T. Harris,Musarrat Hussain,DG Jayne,S. B. Kelly,Michael Lim,S. Maslekar,Danilo Mišković,Catherine Moriarty,M Priestley,S Rawson,Pradeep Sagar,R. N. Saunders,Maria Sheridan,Hilary Speight,Damian Tolan,Leigh White,Lawrence H. Wilkinson,Tim Wilson,David Burling,Sue Clark,Pooja Datt,Chris Fraser,Ashish Gupta,Ian Jenkins,R. H. Kennedy,John Northover,Samia Sakuma,BP Saunders,Noriko Suzuki,Siwan Thomas‐Gibson,Finlay Curran,Debbie Hitchen,A Immanuel,S Kirk,RS Kushwaha,S Lee,M. C. Parker,Angélica Vanessa,Jenny Butler-Barnes,Catherine L. Hough,Aamir Z. Khan,T. Larcombe,Irving M. London,Chelliah Selvasekar,Shafquat Zaman,Jeremy Anderson,Julie Ball,M Basheer,John Brittenden,Adeshina S. Fawole,Rebecca Foster,Kathryn Gill,A Hayton-Bott,Ashley P Jones,Konstantinos Kamposioras,Stephen J. Kerr,T. F. Lowry,Susan Lupton,Christopher P. Macklin,Carl Morrison,Charles Morrison,Himanshu Narula,C Parchment-Smith,Mary A.M. Rogers,Salahuddin Shah,Ranjith Kumar Sivakumar,N. Sivaramakrishnan,Deven Vani,Kamlesh Verma,C Sivanathan,Peter Siao Tick Chong,M. J. Duff,Katherine Duffey,Paul G. Horgan,Lesley McGregor,Ruth F. McKee,John R. Pender,Sowmya Viswanathan,Margaret Ashcroft,James Docherty,Alan Donaldson,Michael Lim,K Macleod,A. MacLeod,Adam Todd,Kenneth Walker,Angus Watson,Hazel M. Younger,John E. Brush,Stephen Glancy,M MacRury,Julian Mander,Hugh Paterson,Leanne Atkin,Caroline Brain,Sarah Brunt,Con Amore V. Burt,Helen Cheshire,Madeleine Clout,H Corderoy,Chen Da-we,A. R. Dixon,H Garlicka,Marina Hopes,S. K. P. John,Kim Kirby,S Kirkpatrick,Robert L. Law,A. J. Longstaff,Eric Loveday,Albert S. Lyons,Kathryn McCarthy,Anne Pullyblank,Aoife Reilly,K Richmond-Russell,A. M. Roe,Leyana R. Saville,Lauren Shelton,Nelson H. Slack,Christopher G. Smith,Liza Solomon,A Treasure,Anil Agarwal,David W Borowski,A. Chilvers,D Dwarakanath,Sean Essex,Dharmendra Garg,Talvinder Gill,Elisabeth Jameson,P Jones-King,S Kiddell,Hadri Latif,Joanne Latimer,Lois E. Shepherd,Sara A. Sinclair,Mohamed Tabaqchali,Hayley Wardle,Deborah Wilson,Anwar Ahmad,Abdul Arain,Mark Cartmell,Kate Cross,Alexandra Davis,J. Groome,Brad Holbrook,S Ley,Neil E. Markham,Mani Menon,John Taylor,F. Thomas,Lynne van Koutrik,Sarfaraz Ahmad,V Cursley,Karin M. Dent,Karen Martin,Dinker R Pai,Sally Anne Pearson,J F Abercrombie,Austin G Acheson,Lewis Aldred,N. C. Armitage,Ayan Banerjea,Chris Coulson,Michael Eyre,Charles Maxwell-Armstrong,Richard F. O’neil,Krish Ragunath,M.H. Robinson,J H Scholefield,Richard Swinden,John P. Williams,Suzie Anthony,Mark Bratby,C Cunningham,Simona Fourie,Oliver P. Jones,Ian Lindsey,Francis S. Morrison,Neil Mortensen,Daniel Munday,Raman Uberoi,Fadzil Ahmad,Nishchay Chandra,Philip G. Conaghan,D. B. Coull,Julie Foxton,Matthew Gibson,W Hameed,Lyn Jones,Donnie McGrath,James R. Ramus,T Samakomva,Archie Speirs,Katherine Walsh,H. Arumugam,A Ewiddison,W Faux,Michael J. Feldman,S Gopalswamy,Lisa Graves,J D Hancock,Philip Harvey,Haizal Mohd Hussaini,Edward Lloyd-Davies,C Lynn,Jillian Madine,Giles Maskell,Nick Morley,Katherine S. Pollard,K Prout,P. Boorman,Brian P. Dickinson,Richard Guinness,Taylor Hill,Jonathan Moran,I. D. Anderson,Anita Ashton,Christopher Babbs,Hal A. Burnett,Kay Goulden,Peter Harrison,Luc Härter,Steven J. Hughes,Victoria Kenyon,S Lee,Nicholas P. Lees,Anna Lydon,Alfred T. Ogden,L Ottiwell,Daci Platt,F.H. Read,Dominic Slade,Chris Thompson,Vinod Cingeetham,David I. Watson,Sarah Brown,Deirdre Donnelly,J Hampton,I. A. Eyre‐Brook,Jayne Foot,Nicholas R. Forsyth,Louise Hunt,Andrew Lowe,P. Mackey,Rudi Matull,Huw Thomas,Christopher Vickery,Grant R. Caddy,Jonathan H. Foreman,Michael E. Hyland,K McCallion,Ethna McFerran,T. C. K. Tham,J. R. A. Turkington,Shelley Day,James Francombe,Patrick F. Murphy,E. Simmons,Rahul Janak Sinha,David A. Bull,A Compson,Michael K. Gould,Sauid Ishaq,Anthony Kawesha,Kataneh Maleki,Mark Marriott,L Poutney,Paul S. Stonelake,Curtis Adams,S. Brundell,M Coleman,H. M. Congdon,Walter Douie,Leonie Eastlake,Louise Evenden,Benjamin Fox,C Gandy,Konstantinos Georgiadis,K. B. Hosie,Andrew Latchford,F. C. Oppong,Jennifer Pascoe,M Rance,Ewen Shepherd,J Shirley,H Smith,Budd Appleton,C Bobary,Mark Feeney,Adrian Gardner,F. F. Krouma,David M. Richards,L Roche,Gail Tudor,Thomas K. Young,A Olufunso,Derek Alderson,Muhammad Atif,Simon Bach,Joanne Dasgin,Colm Forde,Kaori Futaba,Manijeh Ghods-Ghorbani,David Gourevitch,Tariq Ismail,Christopher Hang Liang Keh,N Manimaran,Ian McCafferty,Dion Morton,Steve Pandey,Simon Radley,Peter Riley,J Royle,Nigel Suggett,Andrew Torrance,Olga Tucker,Ravinder Vohra,Jessica Aldous,D. Béal,H Beveridge,S Bradshaw,Anna Carrick,Chris Coulson,J Dockree,Mary C. Fearon,Adrian Hall,Kathleen Holding,N P Hurst,G. B. Irvine,Kyle M Langston,Jonathan N. Lund,GA Redfern,David Reeves,J R Reynolds,Jennifer K. Rowntree,Kim Simmonds,Rajeev Singh,WJ Speake,Gillian Tierney,Samson Tou,C Worth,Baljit Singh,R Verma,Joanna Allison,Andrew Allison,N. C. Bathurst,C Buckley,James Gotto,Zahid Hussain Khan,Jonathan Ockrim,R Rowland-Axe,Ann Russell,Katie Spurdle,Barbara Williams-Yesson,A. Ames,Paul Rylance,Sophia Dyer,Jordan Fletcher,Susan Kent,Nicholas Law,John MacFie,K. S. Mainprize,Joanne Mallinson,Carmel McNaught,Christopher Mitchell,Andrew Nunn,Ian Renwick
出处
期刊:British Journal of Surgery [Oxford University Press]
卷期号:109 (11): 1073-1080 被引量:10
标识
DOI:10.1093/bjs/znac141
摘要

Colorectal cancer often presents with obstruction needing urgent, potentially life-saving decompression. The comparative efficacy and safety of endoluminal stenting versus emergency surgery as initial treatment for such patients is uncertain.Patients with left-sided colonic obstruction and radiological features of carcinoma were randomized to endoluminal stenting using a combined endoscopic/fluoroscopic technique followed by elective surgery 1-4 weeks later, or surgical decompression with or without tumour resection. Treatment allocation was via a central randomization service using a minimization procedure stratified by curative intent, primary tumour site, and severity score (Acute Physiology And Chronic Health Evaluation). Co-primary outcome measures were duration of hospital stay and 30-day mortality. Secondary outcomes were stoma formation, stenting completion and complication rates, perioperative morbidity, 6-month survival, 3-year recurrence, resource use, adherence to chemotherapy, and quality of life. Analyses were undertaken by intention to treat.Between 23 April 2009 and 22 December 2014, 245 patients from 39 hospitals were randomized. Stenting was attempted in 119 of 123 allocated patients (96.7 per cent), achieving relief of obstruction in 98 of 119 (82.4 per cent). For the 89 per cent treated with curative intent, there were no significant differences in 30-day postoperative mortality (3.6 per cent (4 of 110) versus 5.6 per cent (6 of 107); P = 0.48), or duration of hospital stay (median 19 (i.q.r. 11-34) versus 18 (10-28) days; P = 0.94) between stenting followed by delayed elective surgery and emergency surgery. Among patients undergoing potentially curative treatment, stoma formation occurred less frequently in those allocated to stenting than those allocated to immediate surgery (47 of 99 (47.5 per cent) versus 72 of 106 (67.9 per cent); P = 0.003). There were no significant differences in perioperative morbidity, critical care use, quality of life, 3-year recurrence or mortality between treatment groups.Stenting as a bridge to surgery reduces stoma formation without detrimental effects. Registration number: ISRCTN13846816 (http://www.controlled-trials.com).
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