Management of malignant stricture of the esophagogastric junction with a newly designed self-expanding metal stent with an antireflux mechanism.

BACKGROUND AND STUDY AIMS: When stents are placed across the esophagogastric junction for palliative treatment of malignant strictures, they may lead to esophagogastric reflux. The aim of this study was to compare the effectiveness of a newly designed antireflux stent with that of a standard open stent and a currently available antireflux stent (Dostent) in preventing gastroesophageal reflux symptoms in patients with inoperable cancer at the esophagogastric junction. PATIENTS AND METHODS: Thirty-six consecutive patients with cancer at the esophagogastric junction were randomly assigned to undergo placement of a newly designed antireflux stent (n = 12), a Dostent (n = 12), or a standard open stent (n = 12). Technical and clinical success, dysphagia score, reflux symptoms, complications and ambulatory 24-h esophageal pH monitoring were assessed.
RESULTS: The technical success rates were 100 %. After 1 week, dysphagia had improved in all patient groups ( P < 0.05), but the degree of improvement did not differ between the three groups. The DeMeester score was significantly lower in the group with the newly designed antireflux stent than in the other groups. The fraction of the total recording time during which esophageal pH was below 4 was 3.14 +/- 5.78 % using the newly designed antireflux stent, in comparison with 29.25 +/- 15.41 % in the Dostent group and 15.01 +/- 11.72 % in the standard open stent group ( P < 0.001). Fewer reflux episodes occurred with the newly designed antireflux stent than with the Dostent or standard open stent. There were no complications with any of the three stents.
CONCLUSIONS: The newly designed antireflux stent is effective in relieving dysphagia caused by malignant cancer at the esophagogastric junction. The newly designed antireflux stent is significantly more effective in preventing gastroesophageal reflux than currently available antireflux stents.

RCT Entities:   Population Interventions Outcomes