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.

Comparison of Outcomes with Semi-mechanical and Circular Stapled Intrathoracic Esophagogastric Anastomosis following Esophagectomy.

BACKGROUND: Several techniques have been described for esophagogastric anastomosis following esophagectomy. This study compared the outcomes of circular stapled anastomoses with semi-mechanical technique using a linear stapler. METHODS: Perioperative data were extracted from a contemporaneously collected database of all consecutive esophagectomies for cancer with intrathoracic anastomoses performed in the Trent Oesophago-Gastric Unit between January 2015 and April 2018. Anastomotic techniques: circular stapled versus semi-mechanical, were evaluated and outcomes were compared. The primary outcome was anastomotic leak rate. Secondary outcomes included anastomotic stricture, overall complication rates, length of stay (LOS) and 30 day all-cause mortality. RESULTS: One hundred and fifty-nine consecutive esophagectomies with intrathoracic anastomosis were performed during the study period. There were no significant differences between the two groups in terms of age, American Society of Anaesthesiologists score, Charlson comorbidity index and neoadjuvant therapies received. Circular stapled anastomoses were performed in 85 patients, while 74 patients received a semi-mechanical anastomosis. Clavien-Dindo complications II or more were higher in the circular stapled group (p = 0.02). There were 16 (10%) anastomotic leaks overall, three (4%) in semi-mechanical group versus 13 (15%) in the circular stapled group (p < 0.019). There was no statistically significant difference between the two groups in terms of LOS, 30-day mortality or the need for endoscopic dilatation of the anastomosis at 3 months follow-up. CONCLUSION: The move from a circular stapled to a semi-mechanical intrathoracic anastomosis has been associated with a reduced postoperative anastomotic leak rate following esophagectomy for esophageal cancer.

Initial experience with the use of biological implants for soft tissue and chest wall reconstruction in thoracic surgery.

BACKGROUND: Synthetic materials have traditionally been used for tissue reconstruction in thoracic surgery. New biomaterials have been tested in other areas of surgery with good results. The aim of our study is to evaluate our initial experience using prostheses in extended thoracic surgery. METHODS: A review was performed of all patients who underwent extended surgical procedures requiring soft tissue reconstruction with bioprosthetic materials after thoracic surgery from August 2009 to August 2011. A total of 44 consecutive patients were included. Operations involved radical pleurectomy and decortication for mesothelioma (n = 29), extended operations for thoracic malignancies (n = 8), surgery for trauma or perforated organs or complications (n = 6), and for benign infectious causes (n = 1). RESULTS: A total of 76 patches were used in 44 patients (median of 2; range 1 to 3 per patient). Median hospital stay was 13 (range 5 to 149) days. Three patients died during the postoperative period (6.8%); pulmonary embolism 5 days after intrapericardial pneumonectomy with chest wall reconstruction, fatal pneumonia 26 days after radical pleurectomy and decortication for mesothelioma, and bronchopleural fistula 11 days after pneumonectomy with diaphragm and atrium excision for lung cancer after initial chemoradiotherapy. No other surgical exploration or removal of patches has been required for infection. CONCLUSIONS: Our initial experience of using bioprosthetic patches for soft tissue reconstruction in thoracic surgery has proven satisfactory with overall acceptable results. The infection rates are low even when a proportion of procedures were performed under contaminated environments. Biologic prosthesis should be part of the surgical options to reconstruct soft tissues in thoracic surgery.

Marked changes in body composition following neoadjuvant chemotherapy for oesophagogastric cancer.

BACKGROUND & AIMS: Patients with sarcopenia [reduced fat free mass (FFM)] have a higher incidence of chemotherapy-related toxicity and decreased survival. As there are no such data in patients with oesophagogastric cancer (OGC), this study investigated changes in body composition in OGC patients receiving neoadjuvant chemotherapy (NAC). METHODS: OGC patients who had CT scans before and after NAC were studied. CT images at the L3 vertebral level were analysed using SliceOmatic(®) software to derive estimates of FFM and fat mass (FM). Comparisons were made between pre- and post-NAC CT images. Data are reported as mean ± SD. RESULTS: Forty-seven patients (34 male) aged 63 ± 12 years were studied and 79% completed their course of NAC. The interval between CT scans was 107 ± 27 days. The proportion of patients with sarcopenia increased from 57% pre-NAC to 79% post-NAC (p = 0.046). During NAC there were significant reductions in estimated FFM and FM (2.9 ± 4.7 kg, p < 0.0001 and 1.3 ± 3.2 kg, p = 0.007, respectively). No association was demonstrated between loss of FFM and non-completion of NAC, increased hospital stay or mortality. CONCLUSIONS: In patients with OGC commencing NAC, sarcopenia was present in 57%. NAC was associated with further reductions in FFM and an increase in the proportion of patients becoming sarcopenic.

The effect of heparin in peripheral intravenous nutrition via a fine-bore midline: a randomised double-blind controlled trial.

BACKGROUND AND AIMS: Peripheral intravenous nutrition (PIVN) delivered via a finebore midline offers a viable alternative to central venous feeding. The major complication is the onset of peripheral vein thrombophlebitis (PVT). Feed additives such as heparin and hydrocortisone have been advocated in its prevention. Concern over the safety of heparin has prevented its widespread use; this study examines its true benefit. METHODS: A randomised, double-blind trial comparing the addition of either, Heparin 1500 units or hydrocortisone 15 mg or a combination of the two to full intravenous nutrition (IVN) (2500 ml, 13 g of nitrogen, 1190 m0sm/k) was performed. All feeds were delivered via a finebore midline inserted via an antecubital fossa vein. Feeding was terminated in the event of complication or cessation of intended nutritional support. RESULTS: One hundred and twenty-three episodes of feeding occurred in 110 patients. The incidence of peripheral vein thrombosis was similar in each group (Heparin 30% (12/41), hydrocortisone 33% (14/42), combination 31% (13/41) chi(2) test P>0.05). There was a significant difference in total catheter survival with the addition of heparin to the feeds, either alone (11 days (SEM 1.79) or in combination with hydrocortisone (11.7 days (SEM 1.39) compared with those receiving only hydrocortisone (6.9 days (SEM 0.73) P=0.002 and 0.030, respectively)). CONCLUSION: When intravenous feeds are delivered in to a peripheral vein via a fine-bore midline, the addition of heparin to the feed extends the total period of feeding attainable.

In situ diagnosis of intravascular catheter-related bloodstream infection: a comparison of quantitative culture, differential time to positivity, and endoluminal brushing.

OBJECTIVE: To compare the accuracy of three techniques that do not require central venous catheter removal to diagnose catheter-related bloodstream infection. DESIGN: Prospective cohort study of central venous catheters from suspected cases of catheter-related bloodstream infection. SETTING: University teaching hospital. PATIENTS: One hundred and twenty-five central venous catheters from patients with suspected catheter-related bloodstream infection (a raised peripheral white blood cell count, temperature >37 degrees C, and/or local signs of infection at the catheter skin entry site) in intensive care and surgical patients in a large teaching hospital were assessed. INTERVENTIONS: None. MEASUREMENTS: Three techniques were compared: the differential time to positivity of central venous catheter vs. peripheral-blood cultures, quantitative culture of central venous catheter vs. peripheral blood, and the endoluminal brush with peripheral blood culture. MAIN RESULTS: Central venous catheters with a median dwell time of 11 days were examined. There were 36 episodes of catheter-related bloodstream infection, defined as a positive result from at least two of the three tests in the presence of a peripheral blood culture growing the same microorganism and without an identifiable alternative source of sepsis. The sensitivities of the endoluminal brush, quantitative culture, and differential time to positivity techniques were 100%, 89%, and 72%, respectively, with corresponding specificities of 89%, 97%, and 95%. Blood could be directly aspirated from only 231 of 312 (74%) lumens. In the 20 cases of catheter-related bloodstream infection associated with multiple-lumen central venous catheters, endoluminal brushing was positive for one, two, and three lumens in nine (45%), six (30%), and five (25%) cases, respectively. CONCLUSIONS: All three techniques had relatively high sensitivity. However, inability to obtain samples via central venous catheters is a major drawback of the differential time to positivity and quantitative blood culture approaches. Differential time to positivity is simple to perform and has high specificity and therefore could be used as a first line approach, with the endoluminal brush reserved for cases where blood cannot be obtained. All lumens of multiple-lumen central venous catheters must be sampled to ensure maximal sensitivity.

The routine microbiological screening of central venous catheters in home parenteral nutrition patients.

BACKGROUND & AIMS: Catheter-related bloodstream infection (CRBSI) is a major complication for patients receiving home parenteral nutrition (HTPN). Endoluminal sampling techniques allow the diagnosis of CRBSI without catheter removal and may allow the screening of asymptomatic patients. METHODS: Over a 5-year period, patients receiving HTPN were offered screening on a 3 monthly basis. All patients had tunnelled cuffed Hickman lines. All were asymptomatic at the time of screening, which took the form of either endoluminal brushing or quantitative cultures on through-line blood. RESULTS: Thirty-two patients were suitable for inclusion within the study period (10 male, median age 51 (iqr 46-61)) years with 30 of these having a least one screening performed. Four had positive screening results and underwent appropriate treatment. Of the remainder, 12 presented with at least one clinical episode of CRBSI and 14 had neither clinical CRBSI nor a positive screening result. The combined clinical and screening CRBSI rate was 0.39 episodes per catheter year. CONCLUSION: Although routine microbiological catheter screening can detect subclinical infections in HTPN patients the positive rate is low with the majority of patients still presenting clinical. Identification of higher risk patients and appropriate alterations to screening frequency may improve its value further.

Each lumen is a potential source of central venous catheter-related bloodstream infection.

OBJECTIVE: To determine the relative rates of microbial colonization of individual lumens in triple-lumen central venous catheters (CVCs) and calculate the chance of detecting catheter-related blood stream infection (CRBSI) if only one lumen is sampled. DESIGN: Prospective evaluation of CVCs from suspected and nonsuspected CRBSI cases. SETTING: University teaching hospital. PATIENTS: Triple-lumen CVCs from 50 cases of suspected CRBSI (a raised peripheral white blood cell count, temperature >37 degrees C, and/or local signs of infection at the catheter skin entry site) were evaluated. For comparison, 50 triple-lumen CVCs routinely removed at the end of use were evaluated. MEASUREMENTS: In both groups, peripheral blood cultures were taken before CVC removal. After CVC removal, each lumen was sampled in vitro using the endoluminal brush, and the tip was then cultured using the Maki roll technique. MAIN RESULTS: CVCs causing CRBSI had significant microbial colonization in one, two, or three lumens in ten (40%), ten (40%), or five (20%) cases, respectively. Overall, random sampling of only one lumen in CVCs causing CRBSI had a 60% chance of detecting significant colonization. CONCLUSIONS: If only one CVC lumen is sampled, a negative result does not reliably rule out infection. Each lumen of multiple-lumen CVCs should be considered as a potential source of CRBSI.