PURPOSE: To compare the effectiveness of an antireflux stent with that of a standard open stent in preventing symptoms of gastroesophageal reflux in patients with inoperable distal esophageal cancer. MATERIALS AND METHODS: Fifty consecutive patients with inoperable distal esophageal tumors underwentplacement of either a standard open or an antireflux stent across the cardia. Stents were allocated randomly before assessment of the stricture. All patients were followed up prospectively by the departmental research nurses. Technical and clinical success, reflux symptoms, complications, and reintervention rates were assessed. P values of observed differences were calculated by using the chi(2) and log-rank tests as appropriate. RESULTS: The technical success rate was 100%. Improvement in dysphagia was identical in both groups (three points on a five-point scale). Twenty-four (96%) of 25 patients with standard open stents had symptoms of esophageal reflux; 19 (76%) of 25 required treatment. Three (12%) of 25 patients with antireflux stents reported esophageal reflux; one (4%) of 25 required treatment. This difference was significant (P <.001). There was no significant difference in survival, complications, or reintervention rate. One case of late esophageal perforation occurred in each group. One patient died of aspiration within 24 hours after insertion of a standard open stent; no procedure-related deaths occurred with the antireflux stent. CONCLUSION: This antireflux stent is as safe and effective as the standard open stent in relieving malignant dysphagia and was successful in reducing symptomatic gastroesophageal reflux. Copyright RSNA, 2002
RCT Entities:
PURPOSE: To compare the effectiveness of an antireflux stent with that of a standard open stent in preventing symptoms of gastroesophageal reflux in patients with inoperable distal esophageal cancer. MATERIALS AND METHODS: Fifty consecutive patients with inoperable distal esophageal tumors underwent placement of either a standard open or an antireflux stent across the cardia. Stents were allocated randomly before assessment of the stricture. All patients were followed up prospectively by the departmental research nurses. Technical and clinical success, reflux symptoms, complications, and reintervention rates were assessed. P values of observed differences were calculated by using the chi(2) and log-rank tests as appropriate. RESULTS: The technical success rate was 100%. Improvement in dysphagia was identical in both groups (three points on a five-point scale). Twenty-four (96%) of 25 patients with standard open stents had symptoms of esophageal reflux; 19 (76%) of 25 required treatment. Three (12%) of 25 patients with antireflux stents reported esophageal reflux; one (4%) of 25 required treatment. This difference was significant (P <.001). There was no significant difference in survival, complications, or reintervention rate. One case of late esophageal perforation occurred in each group. One patient died of aspiration within 24 hours after insertion of a standard open stent; no procedure-related deaths occurred with the antireflux stent. CONCLUSION: This antireflux stent is as safe and effective as the standard open stent in relieving malignant dysphagia and was successful in reducing symptomatic gastroesophageal reflux. Copyright RSNA, 2002