Minimally invasive or open oesophagectomy for localized oesophageal cancer: Results of the ROMIO phase 3 randomized controlled trial.

e16057 Background: Patients with localised oesophageal adenocarcinoma or squamous cell cancer are frequently offered surgery, usually with neoadjuvant treatment. Whether minimally invasive surgical approaches are superior to standard open procedures in terms of patient recovery and survival benefit is unclear. Well-designed and well-conducted pragmatic trials are limited. The ROMIO study compared laparoscopic abdominal surgery and thoracotomy (LAO) with open oesophagectomy (OO), to test the hypothesis that LAO allows faster recovery than OO whilst maintaining the survival benefit of surgery. Methods: A pragmatic multi-centre randomised controlled trial (1:1 LAO vs. OO) was conducted in 9 major cancer centres in the UK. Included were patients with localised adenocarcinoma or squamous cell cancer selected by a multi-disciplinary team for oesophagectomy with or without neoadjuvant treatment. Surgery was quality assured by provision of a protocol, pre-operative video assessment of the 40 participating surgeons and intra-operative photographs of key agreed surgical components. The primary outcome was the physical function scale of the EORTC QLQ-C30 assessed during the first 3 months. Results: At enrolment to ROMIO 447 (85%) of 526 participants were male, mean age was 67 years (SD 9), 469 (89%) had an adenocarcinoma, 368 (70%) had a clinically staged T3 or T4a tumour, 295 (56%) had clinically positive nodes, and 438 (83%) underwent neoadjuvant treatment. 263 were randomly allocated to each of the two procedures, with 241 (92%) undergoing their allocated open surgery and 237 (91%) undergoing their allocated LAO (hybrid) surgery. Analyses are underway and this presentation will include the primary outcome measure and other short-term clinical outcomes including key complications and survival during the first 90 days (clinical data >95% complete). Conclusions: ROMIO is the largest multi-centre randomised controlled surgical trial of minimal access versus open surgical approaches for oesophageal cancer. The provision of a surgical quality assessment tool will supplement trial data to provide for the first-time evidence of surgical standards of both approaches. Clinical trial information: ISRCTN10386621.