Dua KS, et al. - Given that self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration, researchers evaluated the effectiveness and safety of SEMS with a tricuspid anti-reflux valve (SEMS-V). Phase 3, multicenter, prospective, noninferiority, randomized, controlled trial in patients with malignant dysphagia requiring SEMSs to be placed across the GEJ was conducted. They randomized patients to receive SEMSs with no valve (SEMS-NV) or SEMS-V. The SEMS-V stent relieved dysphagia equally effectively compared to the SEMS-NV stent. They observed that the presence of the valve did not increase the risks of adverse events. Between the two stents, the gastroesophageal reflux disease [GERD] symptom scores were similar, implying either that the valve was not effective or that all proton-pump inhibitors (PPIs) patients could have masked GERD symptoms. In either group, there was no perforation, food impaction or stent-related death. Objective assessment studies such as fluoroscopy and/or pH/impedance are advisable.