The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute⊕ Study

<p>Abstract</p> <p>Background</p> <p>The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing negative for lymph node metastases (i.e. pN0) will subsequently develop locoregional and/or systemic metastases within 5 years. The presence of occult nodal isolated tumor cells (ITCs) and/or micrometastases (MMs) at the time of resection predisposes CC patients to high risk for disease recurrence. These pN0_micro+patients harbouring occult micrometastases may benefit from adjuvant treatment. The purpose of the present study is to delineate the subset of pN0 patients with micrometastases (pN0_micro+) and evaluate the benefits from adjuvant chemotherapy in pN0_micro+CC patients.</p> <p>Methods/design</p> <p>EnRoute+ is an open label, multicenter, randomized controlled clinical trial. All CC patients (age above 18 years) without synchronous locoregional lymph node and/or systemic metastases (clinical stage I-II disease) and operated upon with curative intent are eligible for inclusion. All resected specimens of patients are subject to an <it>ex vivo </it>sentinel lymph node mapping procedure (SLNM) following curative resection. The investigation for micrometastases in pN0 patients is done by extended serial sectioning and immunohistochemistry for pan-cytokeratin in sentinel lymph nodes which are tumour negative upon standard pathological examination. Patients with ITC/MM-positive sentinel lymph nodes (pN0_micro+) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS).</p> <p>Discussion</p> <p>The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0 _micro+CC patients by reducing disease recurrence by adjuvant chemotherapy.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01097265">NCT01097265</a></p

Postoperative efficacy and safety of vessel sealing: an experimental study on carotid arteries of the pig

The aim of this preclinical study was to analyze the burst pressure of large in vivo sealed vessels, not just immediately, but also in the first 7 postoperative days. In 26 anesthetized pigs, the right carotid artery was sealed and cut using a novel device that integrates bipolar and ultrasonic energy. The animals were then awakened. They underwent a second surgical procedure after different follow-up periods ranging from 1 to 7 days: the left common carotid artery was sealed and cut in the same way as the contralateral artery. Perioperative and postoperative clinical events, evolution of burst pressure over time, and comparison between immediate and delayed burst pressure were analyzed. All sealings were successful. There were no perioperative or postoperative complications. Median immediate (day 0) burst pressure was 949 mmHg (IQR 781-1181). Burst pressure decreased postoperatively but was never below 500 mmHg in any pig. Postoperative variations are observed in the burst pressure of in vivo sealed arteries. Immediate burst pressure alone should not be used for validating vascular sealing devices