Introduction
EsoFLIP is a novel dilation balloon that utilizes high-resolution impedance planimetry to provide real-time, objective visualization and monitoring of dilation.
Aims & Methods
The aim of our prospective study is to evaluate clinical and technical success and safety of endoscopic dilation with EsoFLIP in patients affected by benign esophageal strictures (NCT05725473). Patients with symptomatic esophageal strictures, with exception of patients affected by motor disorders, were selected and endoscopic dilatations were performed with EsoFLIP (8-20 mm dilation range). Clinical condition was evaluated before and after procedure (one week and one month) using a specific questionnaire about severity and frequency of dysphagia (Brief Esophageal Dysphagia Questionnaire-BEDQ 10 items from 0 to 6). We also quantified rate of technical success, adverse events, total procedure time and fluoroscopy exposure time. We utilized EndoFLIP (impedance planimetry system) to evaluate stricture diameter (mm), cross-sectional area (CSA mm2), distensibility index (DI mm2/mmHg) before and after dilatation with EsoFLIP.
Results
We enrolled 15 patients affected by esophageal strictures due to lymphocytic (2) and eosinophilic esophagitis (2), caustic ingestion (2), Schatzki rings secondary to GERD (3), esophageal-gastric anastomosis (6). Strictures involved proximal-medial esophagus (18-30 cm from incisors) in 7 patients out of 15 and in 8 out of 15 patients medial-distal esophagus (30-42 cm). All dilation procedures were technically successful, and no adverse events occurred. The median procedure time was 52.67 min (±12.87) and fluoroscopy exposure time was 5.14 min (±1.23; 9.76% of procedure). After 1 week and 1 month from the dilatation there was a significant decrease of dysphagia severity and frequency shown by BEDQ total score (pre-BEDQ 6.87±5.82 vs 1 week-post-BEDQ 3.20±3.69, p-value 0,0486; pre-BEDQ 6.87±5.82 vs 1 month-post-BEDQ 2.33±2.81, p-value 0.0206). After procedure, there was a significant increase of stricture diameter (pre-diameter 8.55±2.80 vs post-diameter 12.44±2.20 mm, p value=0.0002), distensibility index (pre-DI 1.72±1.63 vs post-DI 3.45±1.99 mm2/mmHg, p value= 0.0151) and cross-sectional area (pre-CSA 70.93 ± 45.69 vs post-CSA 114.93± 33.79 mm2, p value=0.0075).
| | Pre Eso-FLIP dilatation | Post Eso-FLIP dilatation | 1 week post Eso-FLIP dilatation | 1 month post Eso-FLIP dilatation |
| BEDQ total score | 6.87±5.82 | | 3.20±3.69 (p= 0.0486) | 2.33±2.81 (p=0.0206) |
| Stricture diameter (mm) | 8.55±2.80 | 12.44±2.20 (p=0.0002) | | |
| Distensibility index (mm2/mmHg) | 1.72±1.63 | 3.45±1.99 (p= 0.0151) | | |
| Stricture cross-sectional area (mm2) | 70.93 ± 45.69 | 114.93± 33.79 (p=0.0075) | | |
Conclusion
Our data showed that endoscopic dilatation of benign esophageal strictures with EsoFLIP is clinically effective and safe. EsoFLIP is a promising dilation technology that may yield a larger diameter change and may potentially reduce fluoroscopy time exposure when compared to traditional endoscopic dilation.
References
Ng K, Mogul D, Hollier J et al. Utility of functional lumen imaging probe in esophageal measurements and dilations: a single pediatric center experience. Surg Endosc. 2020 Mar;34(3):1294-1299
Baumann AJ, Carlson DA. EsoFLIP for esophageal dilation: proposed advantages. Curr Opin Gastroenterol. 2020 Jul;36(4):329-335.