Self-expandable metal stents deployed across the gastroesophageal junction predispose to gastroesophageal reflux.
Dr Siersema and colleagues from the Netherlands undertook a study in order to assess the efficacy of a stent with an antireflux mechanism in preventing gastroesophageal reflux.
The research group included 30 patients with carcinoma of the distal esophagus or of the gastric cardia in the study.
The participants were randomly assigned 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.
The researchers assessed gastroesophageal reflux by using standardized questionnaires and by 24-hour pH monitoring 14 days after treatment.
The research team encountered technical problems during stent placement in 3 patients: migration (n=2) and a problem with the introducing system (n=1).
|Main cause of recurrent dysphagia was stent migration, which occurred in 23% of patients.|
The researchers found that 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.
The research team noted that 3/12 patients (25%) with an antireflux stent reported reflux symptoms, and 2/14 (14%) with an open stent.
The researchers were able to obtain 24-hour pH monitoring in 11 patients.
The research group found that 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).
Dr Siersema concluded, "The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%)."
"The FerX-Ella antireflux stent provided relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia."
He added, "However, the antireflux valve failed to prevent gastroesophageal reflux."