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.

Systematic Review and Meta-Analysis of Epidural Analgesia Versus Different Analgesic Regimes Following Oesophagogastric Resection.

INTRODUCTION: Effective analgesia following open oesophagogastric (OG) resection is considered a key determinant of recovery. This review aimed to compare epidural to alternative analgesic techniques in patients undergoing major open resection for OG cancer. METHODS: A systematic review and meta-analysis was conducted of randomized controlled trials comparing epidural with alternative analgesic methods in open OG surgery. Primary outcome was the overall post-operative morbidity rate. Secondary outcomes included pulmonary complication rates, length of stay (LOS) and pain scores at 24 h. RESULTS: Six trials which comprised of 249 patients were identified (3 following gastrectomy and 3 following oesophagectomy). Following gastrectomy, secondary outcomes including pulmonary complications and dynamic pain scores at 24 h were improved in the epidural groups. No difference was observed in overall morbidity rates or LOS. Following oesophagectomy, overall morbidity rates were not reported at all. LOS was not shortened, and rest pain was not significantly different in the epidural group, but dynamic pain scores were reported to be improved. CONCLUSION: Few trials of analgesic regimen have been performed following open OG resection. In those trials that have been performed, epidural analgesia has not been shown to reduce overall morbidity. Epidural is associated with reduced pulmonary complications after gastrectomy, but no benefit has been shown after oesophagectomy. Whilst widespread investigation of minimally invasive OG techniques currently takes place, it is clear that the most effective patient pathway following open OG surgery, particularly oesophagectomy, is still not proven. Further trials are required.

Argon plasma coagulation compared with stent placement in the palliative treatment of inoperable oesophageal cancer.

BACKGROUND: Self-expandable metal stents (SEMSs) are the main palliative modality used in inoperable oesophageal cancer. Other palliative modalities, including argon plasma coagulation (APC), have also been used. OBJECTIVE: The purpose of this study was to assess the relative efficacy of SEMS and APC regarding the survival of patients with inoperable oesophageal cancer, not receiving chemo/radiotherapy. METHODS: Single centre, retrospective analysis of all patients (n = 228) with inoperable oesophageal cancer between January 2000 and July 2014, not receiving chemo-radiotherapy, treated with SEMS (n = 160) or APC (n = 68) as primary palliation modalities. Cox regression analysis was performed to identify individual factors affecting survival and Kaplan-Meier curves were created for patients treated with APC and SEMS for stage III and IV disease. Survival intervals were compared by the log-rank test. RESULTS: Type of treatment was the only statistically significant factor affecting survival, after disease stage stratification (hazard ratio (HR): 1.36, 95% confidence interval (CI): 1.13-1.65 of SEMS over APC, p: 0.002). Median survival for patients treated with APC and SEMS was 257 (interquartile range (IQR): 414, 124) and 151 (IQR: 241, 61) days respectively in stage III disease. It was 135 (IQR: 238, 43) and 70 (IQR: 148, 32) days respectively in stage IV disease. Both differences were statistically significant (p = 0.02 and 0.05 respectively). CONCLUSIONS: APC is a promising palliation modality in inoperable oesophageal cancer, when patients are not candidates for chemo-radiotherapy. A randomized controlled trial will be needed to confirm those results.

Long-term outcomes following laparoscopic anterior and Nissen fundoplication.

BACKGROUND: Limited evidence exists to which operation gives best long-term outcomes for gastro-oesophageal reflux disease. This study aimed to assess long-term symptomatic outcome and satisfaction following laparoscopic anterior (LA) or Nissen fundoplication in a specialist upper gastrointestinal unit. METHODS: Patients who underwent primary LA or Nissen (LN) fundoplication between May 1994 and June 2010 were identified from a prospectively collected database. DeMeester, modified DeMeester, 'Gastrointestinal Symptom Rating Scale' scores and patient satisfaction were assessed by questionnaire. RESULTS: A total of 387 patients underwent surgery and 246 patients (65%) completed questionnaires, with 181 LA patients and 65 LN patients. Median follow-up was 83 months for LA and 179 months for LN (P < 0.001). A total of 218/245 (89%) reported major improvement in symptoms and 27 (11%) reported poor outcomes. There was no differences between LA and LN for symptom scores at short (<5 years) or long-term follow-up (>5 years). Women reported significantly higher DeMeester scores and lower satisfaction (P = 0.012). One hundred and eighteen (48%) patients were taking proton pump inhibitors (PPI) at follow-up despite high satisfaction rates. CONCLUSION: LA and LN have similar long-term results with patients reporting high satisfaction levels. Women reported more symptoms and less satisfaction than men. Despite high satisfaction rates a high percentage of patients take PPIs.

Surgical and endoscopic management of high grade dysplasia and early oesophageal adenocarcinoma.

BACKGROUND: The introduction of endoscopic techniques has led to debate about optimal management of early oesophageal adenocarcinoma. The aim was to evaluate patient selection and outcomes for endoscopic or surgical treatment at a tertiary referral centre. METHODS: A prospectively collected database of consecutive patients staged with high-grade dysplasia (HGD) or T1 oesophageal adenocarcinoma treated with curative intent between 2005 and 2013 was undertaken. All patients were discussed at the multidisciplinary team meeting. Surgical treatment was by thoracoscopic assisted or standard/laparoscopic assisted Ivor Lewis oesophagectomy. Endoscopic treatment was a structured programme of endoscopic mucosal resection (EMR) and/or radiofrequency ablation (RFA). Outcomes included treatment variables, recurrence and complications. RESULTS: 83 patients treated; 50 with endoscopic therapy (EMR only-4, EMR then RFA-22, RFA only-24) and 38 by surgery (33 straight to surgery and 5 following EMR). Median age (67) and mean follow-up (21 months) were similar. HGD was more common in the endoscopic group (32/50, 64%, vs.3/33, 9%, p = 0.0001). Significant complications were more common following surgery (13/38, 34%, vs. 1/50, 2%, p = 0.0001). There were two in-hospital deaths following oesophagectomy (1 open, 1 thoracoscopic). Endoscopic treatment beyond 12 months for persisting HGD/intramucosal disease was required in 2 patients. Recurrence of HGD/invasive cancer was diagnosed in 2/36 (5.6%, T1a recurrence) of endoscopic and 1/38 (2.6%, T2N0 - subsequent hepatic metastases) surgical patients. CONCLUSION: A management algorithm including both endoscopic treatment and oesophagectomy provides optimal outcome for these patients. Due to additional morbidity of surgery, endoscopic treatment is appropriate first-line treatment.

Surgical management of emergency and elective giant paraesophageal hiatus hernias.

BACKGROUND: Uncertainty exists surrounding the laparoscopic approach to the repair of giant paraesophageal hiatus hernias (GPHHs), in regard to both long-term outcomes and its role in the emergency presentation. The aim of this study was to assess the outcome of laparoscopic GPHH repair, compared with traditional open surgery, in both the elective and emergency setting. SUBJECTS AND METHODS: Data regarding all patients who underwent GPHH repair between January 1994 and June 2008 were retrieved from the prospectively maintained Lothian Surgical Audit database. Demographic details, surgical approach (open/laparoscopic), conversion to an open procedure, complications, and recurrences were analyzed. RESULTS: Sixty-four patients had GPHH repair. Attempted laparoscopic repair and conversion rates were 52 of 64 (81.2%) and 12 of 52 (23.1%), respectively. Including these conversions, 24 of 64 patients had an open repair. The mean postoperative hospital stay, complications, and mortality were significantly lower among the laparoscopic cohort. Twenty-five of 64 patients had surgery as an emergency admission. Postoperative mortality after emergency surgery was 5 of 25 (20.0%) compared with 3 of 39 (7.6%) among elective patients (P=.146). The recurrence rate after laparoscopic and open repair was 25.0% (10 of 40) and 8.3% (2 of 24), respectively (P=.184). CONCLUSIONS: This study has confirmed that surgical repair of GPHH is associated with a significant morbidity and mortality, in both the elective and emergency setting. Although the laparoscopic approach should be attempted in the first instance, the open approach appears to have a lower recurrence rate.

Jejunostomy after oesophagectomy: a review of evidence and current practice.

Patients undergoing oesophagectomy often have nutritional needs at the time of diagnosis and in the post-operative period. The aim of this article is to review the current literature and report on the author's experience of routine feeding jejunostomy insertion following oesophagectomy. The records of forty-eight consecutive patients undergoing oesphagectomy under the author's care were reviewed. Although the evidence of benefit of peri-operative feeding in patients undergoing oesophagectomy is limited, there is a clear need to establish a feeding route at the time of surgery. Oesophagectomy is associated with a mortality rate of 5-10% and a morbidity rate of 30-40% even in high-volume specialist centres. Over 50% of patients developing complications will require an alternative to oral feeding beyond 30 d. The enteral route is preferred in terms of safety and cost. A surgical feeding jejunostomy is associated with a low complication rate and a mortality rate of less than 1%. In forty-eight patients undergoing oesophagectomy the average weight loss at 6 months was 8·4 kg with only 8% regaining their pre-operative weight. Large reductions in weight at 6 months post-operatively were recorded irrespective of the development of post-operative complications or early recurrent disease. Routine jejunostomy insertion is recommended to ensure adequate nutrition in patients who develop post-operative complications and for those patients with long-term reduced appetite and poor oral intake.

Neoadjuvant chemotherapy for carcinoma of the oesophagus and oesophago-gastric junction: a six-year experience.

BACKGROUND: Oesophageal cancer is a major clinical problem with a generally poor prognosis. As a result there has been interest in combining surgery with neoadjuvant chemotherapy to try and improve outcomes, although the current evidence for benefit is inconsistent. We aimed to compare, in a non-randomised study, the post-operative complication rate and short and long-term survival of patients who underwent surgical resection for carcinoma of the oesophagus and types I and II carcinoma of the oesophago-gastric junction with or without neo-adjuvant chemotherapy. METHODS: Details of all resections for oesophageal/junctional (types I and II) adenocarcinoma or squamous cell carcinoma between April 2000 and July 2006 were collected prospectively. Data from patients with T3 and/or N1 disease who underwent either neoadjuvant chemotherapy (NAC) or not (non-NAC) were compared. Data were analysed using Kaplan-Meier plots, Mann-Whitney U-test, Cox Regression modelling, and Chi-squared test with Yates' correction where sample sizes <10. RESULTS: 167 patients were included (89 NAC and 78 non-NAC). The in-hospital post-operative mortality rate of the NAC group (n = 2 deaths; 2.2%) was significantly lower (p = 0.045) than the non-NAC group (n = 6 deaths; 7.7%). Most deaths were due to cardio-respiratory complications; however, there was no significant difference in rates of chest infections, anastomotic leaks, wound infections, re-operations, readmission to ITU or overall complications between the two groups. Although both the two-year survival rate (60.7%) and long-term survival of NAC patients (median survival = 793 days; 95% CI = 390-1196) was greater than non-NAC patients (two-year survival rate = 48.7%; median survival = 554 days; 95% CI = 246-862 respectively), these differences were not statistically significant. CONCLUSION: This non-randomised study demonstrated that NAC was associated with a significant reduction in post-operative inpatient mortality rate. Whether this can be explained by a decreased co-morbidity in NAC patients or a protective phenomenon associated with NAC remains unclear. This study also demonstrated a greater two-year survival rate and overall median survival time following NAC but this was not statistically significant.