Clinical efficacy and safety of endoscopic dilatation with EsoFLIP in benign esophageal strictures: preliminary results of a prospective study

Aims 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. EsoFLIP is a novel dilation balloon that utilizes high-resolution impedance planimetry to provide real-time, objective visualization and monitoring of dilation.

Methods 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 10 patients affected by esophageal strictures due to lymphocytic (2) and eosinophilic esophagitis (1), caustic ingestion (1), Schatzki rings secondary to GERD (3) and esophageal-gastric anastomosis (3). Strictures involved proximal-medial esophagus (18-30 cm from incisors) in 4 patients out of 10 and in 6 out of 10 patients medial-distal esophagus (30-42 cm). All dilation procedures were technically successful, and no adverse events occurred. The median procedure time was 41,2 min (±14.45) and fluoroscopy exposure time was 5,44 min (±1.23; 13,2% 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 12.10±7.85 vs 1 week-post-BEDQ 5.40±4.48, p-value 0.0308; pre-BEDQ 12.10±7.85 vs 1 month-post-BEDQ 3.40±4.38, p-value 0.0067). After procedure, there was a significant increase of stricture diameter (pre-diameter 8.75±2.78 vs post-diameter 12.4±2.57 mm, p value=0.007) and distensibility index (pre-DI 2.0730±1.8521 vs post-DI 4.0380±2.1404 mm2/mmHg, p value=0.0415); a not statistically significant increase in cross-sectional area was reported (post-CSA 119.56±42.59 vs pre-CSA 81.56±44.62 mm2, p value=0.0832).

Conclusions Our preliminary 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.

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Artikel online veröffentlicht:
15. April 2024