Antireflux stents in tumors of the cardia.

Self-expanding metal esophageal stents (SMES) are highly effective in relieving dysphagia in patients with esophageal carcinoma. As the incidence of cancer at the lower esophagus/cardia continues to increase, SMES also are being deployed across the gastroesophageal junction (GEJ). However, use of SMES in this location makes the stomach and the esophagus, in effect, a common cavity, which predisposes patients to gastroesophageal reflux (GER) and aspiration. Reflux may result from an increase in intra-abdominal pressure or it may occur passively when the patient is recumbent. Acid-suppression medications do not protect against regurgitation and aspiration. We developed a modified antireflux SMES and evaluated its efficacy in vitro, in dogs, and in 11 patients with distal esophageal/GEJ carcinoma. The modification involved extending the polyurethane coating of the stent to 8 cm below the lower edge. In dogs, significantly more reflux episodes occurred with the regular stent (mean, 197 episodes) than with the modified stent (mean, 16 episodes; P = 0.03). In patients who received the modified stent, dysphagia scores were significantly reduced (mean baseline score, 3.4; mean end point score, 1.1; P <0.001). The modified stent prevented GER while allowing belching and vomiting.