Through-the-scope placement of a fully covered metal stent for palliation of malignant dysphagia: a prospective cohort study (with video)

Background and Aims To further optimize endoscopic stent placement, an esophageal fully covered self-expandable metal stent with a through-the-scope (TTS) delivery system was designed, providing direct endoscopic control during stent placement. The aim of the study was to assess the feasibility and safety of a TTS stent approach for palliation of malignant dysphagia. Methods This multicenter prospective feasibility study included patients with malignant dysphagia undergoing stent placement. The primary outcome was technical success of TTS stent placement. Secondary outcomes included functional outcome, adverse events, and survival. Patients were prospectively evaluated at days 14 and 28, and monthly thereafter, until death or stent removal. Results In total, 33 stents were placed in 32 patients. TTS stent placement was feasible in 30 (91%) procedures. In the other 3 procedures (9%), no large-channel endoscope could be introduced because of patient discomfort. In 10 (33%) TTS procedures, technical success was achieved because no fluoroscopy and/or guidewire was used, whereas in 20 (67%) TTS procedures, placement was supported by a guidewire (n = 9), or fluoroscopy and a guidewire (n = 11). After 2 weeks, dysphagia scores had improved in 24 (86%) patients. Median dysphagia-free time was 32 days (interquartile range [IQR], 17–76 days). In 20 (63%) patients, 29 serious adverse events (SAEs) occurred. Recurrent dysphagia occurred in 13 (41%) patients due to migration (n = 5), tissue overgrowth (n = 4), and stent deformation (n = 4). Other SAEs included significant retrosternal pain (n = 4), hemorrhage (n = 2), and esophageal perforation (n = 1). No patient died from a stent-related cause. Median survival was 42 days (IQR, 28–91 days). Conclusion Placement of an esophageal TTS stent was feasible in most of the patients with malignant dysphagia. However, stent placement was associated with a relatively high adverse event rate, and in more than one-third of patients, stent placement still required fluoroscopy, which limited optimal benefit of the TTS approach. (Clinical trial registration number: NCT03269903.)