摘要
Self expandable metal stents deployed across the gastroesophageal junction predispose to gastroesophageal reflux. The efficacy of a stent with an antireflux mechanism in preventing gastroesophageal reflux was assessed. Thirty patients with carcinoma of the distal esophagus or of the gastric cardia were randomized to receive either a stent with a windsock-type antireflux valve (FerX-Ella) (n = 15) or a standard open stent (n = 15) of the same design minus the valve. Gastr oesophageal reflux was assessed by using standardized questionnaires and by 24- hour pH monitoring 14 days after treatment. Technical problems occurred during stent placement in 3 patients: migration (n = 2) and a problem with the introduci ng system (n = 1). Dysphagia improved from a median score of 3 (liquids only) to 1 (eat some solid food) in the antireflux group and from 3 to 0 (solid foods) i n the open stent group (p >0.20). Reflux symptoms were reported by 3/12 patients (25%) with an antireflux stent and by 2/14 (14%) with an open stent. In 11 patients, 24-hour pH monitoring was obtained, and increased esophageal acid expos ure (normal: < 4%) was present with both types of stent: median 24-hour reflux time (9 patients) with the antireflux stent was 23% vs. 10% in (2 patients) with the open stent (p = NS). Major complications occurred in 3 patients (20%) in each group and included bleeding (n = 3), severe pain (n = 2), and aspiration pn eumonia (n = 1). The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%). The FerX-Ella antireflux stent provi ded relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia. However, the antireflux valve failed to prevent gastroesophageal reflux .
Self expandable metal stents deployed across the gastroesophageal junction predispose to gastroesophageal reflux. The efficacy of a stent with an antireflux mechanism in preventing gastroesophageal reflux was assessed. Thirty patients with carcinoma of the distal esophagus or of the gastric cardia were randomized to receive either a stent with a windsock-type antireflux valve (FerX-Ella) (n = 15) or a standard open stent (n = 15) of the same design minus the valve. Gastr oesophageal reflux was assessed by using standardized questionnaires and by 24- hour pH monitoring 14 days after treatment. Technical problems occurred during stent placement in 3 patients: migration (n = 2) and a problem with the introduci ng system (n = 1). Dysphagia improved from a median score of 3 (liquids only) to 1 (eat some solid food) in the antireflux group and from 3 to 0 (solid foods) i n the open stent group (p >0.20). Reflux symptoms were reported by 3/12 patients (25%) with an antireflux stent and by 2/14 (14%) with an open stent. In 11 patients, 24-hour pH monitoring was obtained, and increased esophageal acid expos ure (normal: < 4%) was present with both types of stent: median 24-hour reflux time (9 patients) with the antireflux stent was 23% vs. 10% in (2 patients) with the open stent (p = NS). Major complications occurred in 3 patients (20%) in each group and included bleeding (n = 3), severe pain (n = 2), and aspiration pn eumonia (n = 1). The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%). The FerX-Ella antireflux stent provi ded relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia. However, the antireflux valve failed to prevent gastroesophageal reflux .
