Minimally invasive or open oesophagectomy for localised oesophageal cancer: results of the ROMIO pragmatic randomised controlled trial
Session type: E-poster/poster
Patients with localised oesophageal adenocarcinoma or squamous cell cancer are frequently offered surgery. Post-surgery there is a major impact on health-related quality of life, provoking interest in approaches to enhancing recovery. We 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.
A NIHR-funded pragmatic randomised controlled trial conducted in nine UK centres (project ref HTA 14/140/78). Patients were selected by multi-disciplinary teams for oesophagectomy with or without neoadjuvant treatment. Surgery was quality assured by surgical protocols, pre-operative video assessment of the 40 participating surgeons, and intra-operative photographs of key surgical components. Here we report on early outcomes including the primary outcome: the physical function scale of the EORTC QLQ-C30 (range 0 to 100) assessed during the first 3 months.
At enrolment 448 (85%) of 527 participants were male, mean age was 67 years (SD 9), 469 (89%) had an adenocarcinoma, 371 (71%) had a clinically staged T3 or T4a tumour, 296 (56%) had positive nodes, and 438 (83%) underwent neoadjuvant treatment. 241 of 263 (92%) participants underwent their allocated OO, and 231 (89%) contributed to the primary outcome, whilst 237 of 264 (91%) participants underwent their allocated LAO and 232 (90%) contributed to the primary outcome. Participants allocated to hybrid surgery reported better average physical function over the three months following randomisation, but the difference was small and consistent with chance: difference in means 2, 95% confidence interval -2 to 6, p=0.3. Complication rates were similar between the allocated groups, for example 88 (34%) of participants in the OO and 82 (32%) of participants in the LAO groups experienced a pulmonary infection within 30 days of surgery.
The ROMIO study did not identify any differences between OO and LAO in post-surgical recovery or complications. Health economic and longer-term survival data will be available in early 2022.
The ROMIO randomised controlled trial provides no evidence of differences in post-surgical recovery or complications between open and hybrid oesophagectomy in the treatment of localised oesophageal cancer.