Background: A major limitation of current treatment strategies for nonmalignant upper gastrointestinal stenoses is the lack of either optical or haptic feedback during dilation. Wire guidance and fluoroscopy is often necessary to control the position.
Methods: A novel device for endoscopic dilation, the BougieCap (Ovesco Endoscopy AG, Tübingen, Germany) was evaluated in a prospective multicenter trial. Primary outcome was successful dilation of stenosis and secondary outcome was alteration in dysphagia symptoms in short-term follow-up. RESULTS: 50 patients with benign esophageal strictures were included. Endoscopic bougienage was successful in 96 %. Bougienage failed in two cases because of high resistance. Symptoms of dysphagia decreased significantly after bougienage (59.0 points at Day 0 vs. 28.6 points at Day 14; P < 0.001). Adverse events were loss of BougieCap into the stomach in two cases; no severe adverse events were reported.
Conclusions: Endoscopic treatment of benign stenoses using the BougieCap enabled direct visual control of the bougienage procedure. This might help to adapt treatment more precisely to the stricture. Symptoms of dysphagia were improved in short-term follow-up. Additional wire guidance may be used for selected cases (e. g. narrow lumen, pediatric scope).
Trial registration: ClinicalTrials.gov NCT03349021.
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