Background. There is little prospective data on whether bigger plastic stents are better for patients with malignant biliary obstruction with jaundice. Goals. Multicenter prospective study to compare technical success, clinical response, stent occlusion, and patient survival in patients with malignant biliary obstruction randomized to 10-French or 11.5-French plastic stent. Study. Patients with malignant biliary obstruction were randomized to 10-French or 11.5-French biliary stents. Patients were prospectively assessed for stent occlusion, stent-related interventions, hospital stay, and change in bilirubin. Main outcome measurements included technical success, clinical response, rates of stent occlusion, and survival. Results. 234 patients (47 hilar and 187 common bile duct strictures) were randomized. Outcomes were similar for the 10-French and 11.5-French groups (technical success 99.1% versus 97.4%, ). Overall, median stent survival was 213 days, but there was no statistically significant difference in stent survival between 10-French and 11.5-French stents (149 versus 258 days, ). Stent survival was significantly longer when placed for common bile duct versus hilar strictures (231 versus 115 days, ). Conclusions. The theoretical advantage of improved bile flow for the 11.5-French stent does not translate into more prolonged patency, better clinical response, and longer patient survival than the 10-French stent. 1. Introduction The majority of patients presenting with symptoms of malignant biliary obstruction are considered unsuitable for surgery because of locally advanced or metastatic disease or poor performance status. Palliative biliary stenting at ERCP is frequently the only planned therapy. Endoscopic biliary stenting was first described by Soehendra and Reynders-Frederix [1] in 1980 and since then has become the preferred method to relieve jaundice and improve quality of life for patients with advanced malignant biliary obstruction [2–5]. Several studies have shown that this technique is associated with fewer complications and lower costs than surgical bypass or percutaneous drainage [6–10]. The major limitation to long-term biliary stenting is stent occlusion which particularly affects plastic stents whose average patency is 4 months for the 10 French (Fr) polyethylene stents [11, 12]. The most commonly used plastic stent is the straight polyethylene stent with distal and proximal end holes and an adjacent side hole at its tip [13]. The most cost effective strategy to prolong stent patency is the use of larger stent diameter. However, while
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