A New Type of Balloon Catheter-Based Dilatation Intervention for Patients With Cricopharyngeus Achalasia After Stroke: A Randomized Study

Abstract

Purpose To investigated the efficacy and safety of a new type of balloon catheter in dilatation intervention for patients with cricopharyngeus achalasia after stroke. Methods Fifty-two patients with cricopharyngeus achalasia after stroke received routinely swallowing rehabilitation trainings and were randomly assigned to: an experimental group (n = 26) that received dilatation therapy using this new balloon catheter one time per day for 5 days per week and a control group (n = 26) that received dilatation therapy with NO.14 ordinary urinary catheter one time per day for 5 days per week. Duration of intervention, EAT-10 and FOIS scores were recorded at baseline and every day during intervention. The time for FOIS score ≥ 3, the time for recovery of oral intake of water, liquid food, mushy food and solid food were recorded and estimated. Complications were recorded during intervention. Results The Exp group had shorter duration of intervention compared to the Con group (p < 0.001). Exp group improved faster than Con group with shorter recovery time for oral intake of liquid food (p < 0.001), mushy food (p = 0.001) and solid food (p < 0.001). At the termination of intervention, EAT-10 score was lower in Exp group than in Con group (p = 0.002). Compared to the Con group, Exp group had similar incidence of complications but better tolerability (p = 0.006). Conclusion Using this new balloon catheter for dilatation improves more and faster than using ordinary urinary catheter in patients with cricopharyngeus achalasia after stroke.