Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction.

BACKGROUND AND AIM: Metal stents placed across the gastroesophageal junction in patients with malignant dysphagia frequently present with reflux symptoms. We compared an antireflux stent with a standard open stent used in combination with proton pump inhibitor medication.

METHODS: Forty-nine patients with dysphagia due to inoperable carcinoma in the lower third of the esophagus were randomly selected to receive either a antireflux valve stent (FerX-Ella) (n = 22) or a covered standard open stent (Ultraflex), which was combined with proton pump inhibitors such as omeprazole (n = 26). The technical success, the presence of reflux, and complications were recorded.

RESULTS: Reflux was seen in 3/22 patients (13.6%) in the FerX-Ella group and in 2/26 patients (7.7%) in the Ultraflex and proton pump inhibitor combination group (P-value not significant). In both groups, a significant improvement in the dysphagia score was seen and no statistically significant difference was detected between the two groups (P = 0.84). The FerX-Ella stents migrated more frequently (32%) than the Ultraflex stents (23%). This also necessitated surgical intervention more frequently in the FerX-Ella group (2/22, 9.1%) compared to the Ultraflex group (1/26, 3.8%).

CONCLUSION: The antireflux stent had no demonstrable advantages compared to the combination of standard open stent and proton pump inhibitor medication.