Safety and Efficacy of Through-the-Scope Fully Covered Self-Expanding Metal Stents Across Diverse Benign and Malignant Esophageal Pathologies - A Retrospective Cohort Study (with video)

<title>Abstract</title> <p> <bold>Background and Aims</bold> Through-the-scope (TTS) fully covered self-expanding metal stents (FCSEMSs) are an emerging endoscopic stent platform that permit deployment through the working channel of a therapeutic endoscope under continuous endoscopic visualization, frequently without fluoroscopy. Compared with conventional over-the-wire (OTW) systems, TTS stents may offer practical advantages, including improved positional control in angulated or surgically altered anatomy, reduced reliance on fluoroscopy, and broader procedural accessibility. However, published experience with TTS FCSEMSs is limited and mainly focused primarily on malignant dysphagia, and data supporting their use across broader esophageal and foregut indications, including luminal defects, bleeding, and complex benign conditions, remain limited. We aimed to evaluate the safety, technical success, clinical outcomes, and migration profile of TTS FCSEMSs deployed across diverse benign and malignant esophageal and foregut indications in routine clinical practice and to contextualize these findings within the published OTW SEMS literature. <bold>Methods</bold> We conducted a single-center retrospective cohort study of consecutive adults undergoing TTS FCSEMS placement at Ruby Memorial Hospital, West Virginia University (January 2020–August 2025). Indications included malignant obstruction and a broad range of benign pathologies: refractory peptic, radiation-induced, and anastomotic strictures; post-sleeve gastrectomy and anastomotic leaks; iatrogenic and spontaneous perforations; esophageal fistulas; ulcer-related hemorrhage; and eroded intragastric devices. Technical success was defined as complete stent deployment at the intended location. Clinical success was defined as 30-day reintervention-free survival and/or meaningful symptomatic improvement at 14 days. Migration-free survival was analyzed using Kaplan-Meier methods, and adverse events were classified by standardized criteria. <bold>Results</bold> Sixty-four patients underwent 64 index TTS FCSEMS procedures (27 benign, 37 malignant); median age was 63 years. Indications spanned strictures (20.3%), malignancy (57.8%), leaks (9.4%), perforations (6.3%), fistulas (1.6%), bleeding ulcers (3.1%), and eroded gastric band (1.6%). Technical success was 100% in both groups. Clinical success was achieved in 44 of 64 patients (68.8%): 66.7% benign, 70.3% malignant. Fluoroscopy was used in only 46.9% of procedures. Stent migration occurred in 7 patients (10.9%); all were managed endoscopically. Overall adverse events occurred in 11 patients (17.2%), comprising intolerance requiring removal (7.8%), tissue overgrowth (6.3%), and bleeding (3.1%). No perforations or procedure-related deaths occurred. Migration rates were substantially lower than historical OTW series (25–40%), attributable in part to endoscopic fixation in 79.7% of cases. <bold>Conclusions</bold> TTS FCSEMS placement demonstrated high technical success, acceptable clinical effectiveness, and a favorable safety profile across a broad spectrum of benign and malignant esophageal and foregut indications beyond malignant dysphagia. The platform allowed frequent deployment without fluoroscopy and may offer practical advantages in challenging anatomy and urgent clinical scenarios. Endoscopic fixation was commonly used and may have contributed to the low observed migration rate. Further prospective comparative studies are needed. </p>