eprintid: 10077352 rev_number: 30 eprint_status: archive userid: 608 dir: disk0/10/07/73/52 datestamp: 2019-07-17 15:59:40 lastmod: 2021-12-16 23:43:46 status_changed: 2019-07-17 15:59:40 type: article metadata_visibility: show creators_name: Allum, WH creators_name: Smyth, EC creators_name: Blazeby, JM creators_name: Grabsch, HI creators_name: Griffin, SM creators_name: Rowley, S creators_name: Cafferty, FH creators_name: Langley, RE creators_name: Cunningham, D title: Quality assurance of surgery in the randomized ST03 trial of perioperative chemotherapy in carcinoma of the stomach and gastro‐oesophageal junction ispublished: pub divisions: UCL divisions: B02 divisions: D65 divisions: J38 note: Copyright © 2019 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited. abstract: BACKGROUND: The UK Medical Research Council ST03 trial compared perioperative epirubicin, cisplatin and capecitabine (ECX) chemotherapy with or without bevacizumab (B) in gastric and oesophagogastric junctional cancer. No difference in survival was noted between the arms of the trial. The present study reviewed the standards and performance of surgery in the context of the protocol-specified surgical criteria. METHODS: Surgical and pathological clinical report forms were reviewed to determine adherence to the surgical protocols, perioperative morbidity and mortality, and final histopathological stage for all patients treated in the study. RESULTS: Of 1063 patients randomized, 895 (84·2 per cent) underwent resection; surgical details were available for 880 (98·3 per cent). Postoperative assessment data were available for 873 patients; complications occurred in 458 (52·5 per cent) overall, of whom 71 (8·1 per cent) developed complications deemed to be life-threatening by the responsible clinician. The most common complications were respiratory (211 patients, 24·2 per cent). The anastomotic leak rate was 118 of 873 (13·5 per cent) overall; among those who underwent oesophagogastrectomy, the rate was higher in the group receiving ECX-B (23·6 per cent versus 9·9 per cent in the ECX group). Pathological assessment data were available for 845 patients. At least 15 nodes were removed in 82·5 per cent of resections and the median lymph node harvest was 24 (i.q.r. 17-34). Twenty-five or more nodes were removed in 49·0 per cent of patients. Histopathologically, the R1 rate was 24·9 per cent (208 of 834 patients). An R1 resection was more common for proximal tumours. CONCLUSION: In the ST03 trial, the performance of surgery met the protocol-stipulated criteria. Registration number: NCT00450203 ( http://www.clinicaltrials.gov). date: 2019-08 date_type: published official_url: https://doi.org/10.1002/bjs.11184 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1669222 doi: 10.1002/bjs.11184 lyricists_name: Cafferty, Fay lyricists_name: Langley, Ruth lyricists_id: FCAFF86 lyricists_id: RELAN40 actors_name: Allington-Smith, Dominic actors_id: DAALL44 actors_role: owner full_text_status: public publication: BJS volume: 106 number: 9 pagerange: 1204-1215 event_location: England issn: 1365-2168 citation: Allum, WH; Smyth, EC; Blazeby, JM; Grabsch, HI; Griffin, SM; Rowley, S; Cafferty, FH; ... Cunningham, D; + view all <#> Allum, WH; Smyth, EC; Blazeby, JM; Grabsch, HI; Griffin, SM; Rowley, S; Cafferty, FH; Langley, RE; Cunningham, D; - view fewer <#> (2019) Quality assurance of surgery in the randomized ST03 trial of perioperative chemotherapy in carcinoma of the stomach and gastro‐oesophageal junction. BJS , 106 (9) pp. 1204-1215. 10.1002/bjs.11184 <https://doi.org/10.1002/bjs.11184>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10077352/3/Allum_et_al-2019-British_Journal_of_Surgery.pdf