Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

Prognostic value of baseline FDG uptake on PET-CT in esophageal carcinoma.

AIM: To evaluate the influence of baseline maximum standardized uptake value (SUVmax) on survival in a cohort of patients, undergoing positron emission tomography-computed tomography (PET-CT) scan for esophageal carcinoma. METHODS: The pre-treatment SUVmax numeric reading was determined in patients with confirmed esophageal or junctional cancer having PET-CT scan during the time period 1(st) January 2007 until 31(st) July 2012. A minimum follow up of 12 mo was required. Patients were subdivided into quartiles according to SUVmax value and the influence of SUVmax on survival was assessed using univariate and multivariate analysis. The following pre-treatment factors were investigated: patient characteristics, tumor characteristics and planned treatment. RESULTS: The study population was 271 patients (191 male) with esophageal or junctional carcinoma. The median age was 65 years (range 40-85) and histologic subtype was adenocarcinoma in 197 patients and squamous carcinoma in 74 patients. The treatment intent was radical in 182 and palliative in 89 patients. SUVmax was linked to histologic subtype (P = 0.008), tumor site (P = 0.01) and Union for International Cancer Control (UICC) stage (P < 0.001). On univariate analysis, prognosis was significantly associated with SUVmax (P = 0.001), T-stage (P < 0.001) and UICC stage (P < 0.001). On multivariate analysis, only T-stage and UICC stage remained significant. CONCLUSION: Pretreatment SUVmax was not a useful marker in isolation for determining prognosis of patients with esophageal carcinoma.

Management of esophageal perforation and anastomotic leak by transluminal drainage.

INTRODUCTION: The management of esophageal perforations and leaks remains a challenge. Although there are broad management principles, each situation may require a different surgical approach. The aim of this report was to describe the management of these esophageal crises by transluminal drainage via a transabdominal approach. METHODS: Between 2005 and 2009, patients with anastomotic or gastric staple line leak (n = 4) or esophageal perforation (n = 2) underwent transabdominal surgery and transluminal drainage. This simple technique has, to the best of our knowledge, not been previously reported. RESULTS: All six patients survived. The median intensive care unit and hospital stays were 12 days (range 0-32) and 63 days (range 32-99), respectively. At a median follow-up time of 25 months (range 15-60), five of the six patients remain alive and well. One patient with node positive esophageal carcinoma has died from relapsed disease. CONCLUSIONS: Transabdominal transluminal drainage should be added to the list of potential techniques that can be employed in management of esophageal leaks and perforations. It is a valuable adjunct to the armamentarium of the esophageal surgeon for dealing with these challenging situations.