Post written by Kulwinder S. Dua, MD, FASGE, FACP, FRCP, from the Department of Medicine, Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

The purpose of this study was to evaluate the safety and efficacy of a new self-expanding metal esophageal stent (SEMS) with an anti-reflux valve in relieving dysphagia symptoms and simultaneously preventing gastroesophageal reflux symptoms when deployed across the gastroesophageal junction (GEJ).

The incidence of adenocarcinoma of the esophagus is rising, and most of these patients present with advanced disease requiring palliation of dysphagia symptoms. Since the majority of these cancers are located in the lower esophagus, SEMS used for palliating dysphagia have to be deployed across the GEJ. This allows for free reflux of gastric contents (including recently eaten food) into the esophagus and besides reflux symptoms, patients are at risk of aspiration pneumonia and death. Hence we need a SEMS that not only can effectively palliate dysphagia but also prevents gastroesophageal reflux disease (GERD).

To address the above, a new SEMS was designed that had a tricuspid anti-reflux valve attached in its lower end (SEMS-V). The safety and efficacy of this stent in relieving dysphagia (using the dysphagia grade scale) and preventing reflux (using the GERD-HRQL scores) was compared to a standard identical SEMS without a valve (SEMS-NV) in a prospective, randomized controlled, single-blinded study on patients with lower esophageal cancers. Similar to SEMS-NV, SEMS-V was effective in relieving dysphagia but was not found to be superior in preventing reflux. Side-effects and adverse events rates were similar in the 2 groups.

Figure 1. A, Standard self-expanding metal esophageal stent with no valve. B, Modified self-expanding metal esophageal stent with a tricuspid antireflux valve.

With the rising incidence of esophageal cancers involving the lower esophagus requiring SEMS to be placed across the GEJ, there is an unmet need of having SEMS that not only can effectively palliate dysphagia but also simultaneously prevent gastroesophageal reflux. Although the tricuspid-valve design in this study was not effective in preventing reflux, newer designs may have to be developed.

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