Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway <it>the greater saphenous vein </it>continues to be the most commonly used bypass conduit. <it>Minimally invasive endoscopic saphenous vein harvesting </it>is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature.</p> <p>Methods/Design</p> <p><b>Endoscopic Saphenous harvesting with an Open CO₂System </b>trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.</p> <p>Discussion</p> <p>The goal of this prospective randomized trial is to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO₂harvesting system versus conventional vein harvesting.</p> <p>The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.</p> <p>Trial registration</p> <p>www.clinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01121341">NCT01121341</a>.</p

Pulmonary adenocarcinomas: a single-centre validation study of the clinical and prognostic utility of the WHO/ IASLC subtype classification

Objective: Adenocarcinoma is the most frequently reported histological subtype of lung carcinoma in many series as well as the most histologically variable and heterogeneous form. A WHO/IASLC classification of pulmonary adenocarcinomas was proposed in 2004 suggesting clinical and prognostic implications for the different subtypes. The aim of the present study was to analyze our patient population of resected patients with adenocarcinoma according to the WHO/IASLC classification to evaluate its clinical and prognostic utility Methods: From January 2004 to October 2008 a total of 277 patients received curative resection of primary lung adenocarcinoma at our Institution. There were 191 men (69%) and 86 women (31%) with a mean age of 65 years (range 42-82 years). The tumours were classified according to the 2004 WHO/IASLC classification into: acinar adenocarcinomas (AC), papillary/micropapillary adenocarcinomas (PAP), bronchiolo-alveolar carcinomas (BAC), and solid adenocarcinomas with mucin production (SOL). Adenocarcinomas with mixed subtypes were reclassified according to the most prevalent histotype. Prevalence, correlations and survival analysis both univariate and multivariate using some clinico-pathological variables (age, microscopic vascular invasion, grading, perineural invasion, tumourinfiltrating lymphocytes, T, N status and pathologic Stage) were performed among the different subgroups. Results: There were 41 AC, 82 PAP ( 45 pure papillary and 37 mixed papillary/micropapillary when a >5% micropapillary component was present), 30 BAC, 15 SOL. 10 adenocarcinomas were variant subtypes, including clear cell (4), signet ring (4) and pseudosarcomatous (2) adenocarcinomas. In 99 patients the histological subtype could not be defined. BAC were significantly associated with a less microscopic vascular invasion (p=0.01), a lower grading (G1) (p=0.0001) and a lower N status (p=0.02). Acinar and solid adenocarcinomas showed no significant correlation with any clinico-pathological variable. Papillary/micropapillary adenocarcinomas were associated with a higher grading (G3) (p=0.05). 3-year survival rates for the different subtypes were: BAC, 78%; AC, 75%; SOL, 67% and PAP 62% (pure papillary 68%, mixed papillary/micropapillary 53%). The 99 undefined adenocarcinomas had a 3 year survival rate of 75%. The differences among the groups were not significant (p=0.6). In multivariate analysis, the subgroup classification was not an independent prognostic indicator (HR 1.02, 95%CI 0.84-1.23). Conclusions: In our experience, about one-third of resected pulmonary adenocarcinomas cannot be classified into subtypes using standard histopathologic techniques. The papillary/micropapillary pattern is associated with a higher dedifferentiation, and the micropapillary component confers a survival disadvantage which however was not significant in the present series. Classification of pulmonary adenocarcinomas into subtypes was not an independent prognostic factor in multivariate survival analysis. Although promising, the prognostic utility of the WHO/IASLC adenocarcinoma classification needs to be verified on a larger number of patients