No abstract

2011-003038-14.

Background A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. Methods Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia [ 2 cm. Results The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230°(160°-300°). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with C50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p \ 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. Conclusion The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and G.

Despite a number of efforts being put into the radiological protection of both patient and staff during interventional radiological (IR) procedures during recent years, information about radiation exposure during endoscopic retrograde cholangiopancreatography (ERCP) procedures remains scarce. The purpose of this study was to estimate both patient and staff radiation doses during therapeutic ERCP procedures by direct measurement and to compare these results with data from other IR procedures. For 54 patients, effective dose and skin dose were estimated by measuring the dose-area product. For staff, entrance surface doses to the lens of the eye, thyroid and hands were estimated by thermoluminescent dosemeters. A median effective dose of 7.3 mSv and a median entrance surface dose of 271 mGy per procedure were estimated for patients. The gastroenterologist received a median dose of 0.34 mGy to the lens of the eye, 0.30 mGy to the skin at the level of the thyroid and 0.44 mGy to the skin of the hands, per procedure. When comparing the dosimetric quantities presented in this study with data from other IR procedures, it is clear that patient skin doses and doses to staff are high owing to the use of inappropriate X-ray equipment. ERCP requires the same radiation protection practice as all IR procedures. It should be consistently included in future multicentre IR patient and staff dose survey studies at national or international level.