Randomized trial of small-diameter versus large-diameter esophageal stents for palliation of malignant esophageal obstruction

Goals: To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction. Background: Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown. Study: A prospective randomized trial was conducted at a regional referral hospital. One hundred persons with unresectable esophageal cancer were enrolled, randomized to receive a SEMS of either 18 or 23mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival. Results: The study arms were evenly matched. Dysphagia resolved after stent placement in 95% in both groups. After 6 months the cumulative incidence of recurrent dysphagia was 38% (95% CI 18%-53%) versus 47% (26%-63%) in the small-diameter versus large-diameter groups, respectively (P=0.23). The cumulative incidence of adverse events was 57% in both groups at 6 months, with trends toward more frequent gastrointestinal bleeding and esophago-respiratory fistula in the large-diameter group, and more frequent stent migration, stent occlusion, and endoscopic reintervention in the small-diameter group. There was a trend toward longer survival in the small-diameter group (median survival, 5.9 vs. 3 mo; P=0.10). Higher initial performance status score and female gender were associated with improved survival. Limitations include enrollment of only 100 (of a planned 200) persons and incomplete follow-up of some participants. Conclusions: Small-diameter and large-diameter esophageal SEMS provided similar palliation of dysphagia due to esophageal cancer. The overall incidence of adverse events was not affected by stent diameter, but there was a trend toward longer survival with smalldiameter stents (Clinical trial registration number: NCT01894763).