Efficacy and safety of a novel multisegmented fully covered self-expanding metal stent for malignant esophageal obstruction: a prospective pilot study with historical control.

BACKGROUND AND AIMS: Self-expanding metal stents (SEMSs) are effective for symptom palliation in patients with esophageal obstruction. However, their placement can lead to adverse events such as stent migration and restenosis. A novel fully covered SEMS (FCSEMS) with antimigration properties has been developed to address these issues. This study aimed to evaluate the feasibility and safety of this novel stent in treating malignant esophageal obstruction.

METHODS

This prospective pilot study enrolled patients with malignant esophageal obstruction treated with the novel stent at a tertiary referral center. Primary outcomes included technical and clinical efficacy, whereas secondary outcomes were adverse events. Treatment outcomes were compared between the novel stent and historical control groups.

RESULTS

137 patients were analyzed, comprising 32 in the novel stent group and 105 in the historical control group. In the novel stent group, technical success was achieved in 100% of patients and clinical success in 96.9%. No stent placement-related events, including bleeding or perforation, were observed. Though no significant differences in adverse events were found, the novel stent group had a lower migration rate than the historical control group (9.4% vs. 14.3%, p = 0.565). Median stent patency was similar between the groups (70.5 vs. 43.0 days, p = 0.185).

CONCLUSIONS

The novel multisegmented FCSEMS demonstrated high technical and clinical efficacy with a low migration rate, presenting a promising treatment option for malignant esophageal obstruction. Further studies with larger samples are needed to confirm these findings.