345. PERI-OPERATIVE SELECTIVE DECONTAMINATION OF THE DIGESTIVE TRACT TO PREVENT SEVERE INFECTIOUS COMPLICATIONS AFTER ESOPHAGECTOMY: A RANDOMIZED MULTICENTER CLINICAL TRIAL

Abstract Protocol presentation Rationale: Esophagectomy is a complex surgical procedure, associated with significant morbidity and mortality rates. Most postoperative complications are caused by infections (10–30%). These are thought to arise from (micro-)aspiration of bacteria residing in the oropharyngeal and gastrointestinal (GI) tract, leading to (respiratory) infections. Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic strategy that aims to prevent postoperative infections. Pathogenic aerobic gram-negative rods and yeasts are reduced, while anaerobic, protective microbiota are preserved. SDD has been shown to lower the risk for respiratory infections in an intensive care setting. Establishing SDD as effective addition to the standard care of esophagectomy patients is expected to increase their chance of survival. Objective Robust and prospective evaluation of SDD after esophagectomy as a protective strategy reducing postoperative pneumonia and other infectious complications, anastomotic leakage and mortality. Study design and population A randomized, controlled, open-label, multicentre trial, including 854 patients with primary resectable esophageal carcinoma ((y)cT1-4a N0-3 M0) planned for transthoracic esophagectomy. Intervention The intervention group receives SDD treatment additional to standard care. An oral suspension (10ml) containing amphotericin B (50 mg/ml), colistin sulphate (10 mg/ml), and tobramycin (8 mg/ml). Patients take the oral suspension four times daily for one week, starting three days prior to the surgery. On the day of surgery, intake is limited to an early morning and a late evening dose. All other facets of care are equal to the control group (standard care without SDD). Two microbial samples will be taken from the esophageal resection specimen (one proximal and one from the distal part) for culture to evaluate effectiveness and compliance of SDD application in control as well as in the intervention group. Furthermore, all participants will be asked to keep a diary. Main study parameters The cumulative incidence of postoperative pneumonia within 30 days after surgery. Secondary study parameters The cumulative incidence of all postoperative complications and re-operation within 30 days after surgery, all- cause mortality within 90 days, length of stay and readmissions within 6 months and quality of life, direct and indirect costs; a week before, 30 days-, 3 months and 6 months after surgery.