Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial

Background

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.

Methods

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. Gastroesophageal reflux was assessed by using standardized questionnaires and by 24-hour pH monitoring 14 days after treatment.

Results

Technical problems occurred during stent placement in 3 patients: migration (n=2) and a problem with the introducing 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) in 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 exposure (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 pneumonia (n=1). The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%).

Conclusions

The FerX-Ella antireflux stent provided relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia. However, the antireflux valve failed to prevent gastroesophageal reflux.