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.
