Treatment of recurrent esophageal strictures with a paclitaxel-coated balloon dilator: initial United States experience.

BACKGROUND AND AIMS: Recurrent esophageal strictures reduce the quality of life for patients and represent a significant burden for health care providers. A novel drug-coated balloon (DCB) dilator has been developed to decrease stricture recurrence. We report the first U.S.-based prospective study of the DCB evaluating pharmacokinetic parameters and clinical outcomes after treatment of recurrent esophageal strictures. This study was a substudy conducted before initiating a randomized controlled trial but using the same entry criteria.

METHODS

25 patients with recurrent esophageal strictures were enrolled at 10 U.S.

CENTERS: All patients' index treatment included endoscopy with stricture assessment with a functional lumen imaging probe (FLIP), symptom assessment using the Ogilvie Score and Dysphagia Handicap Index (DHI), followed by dilation with the drug-coated balloon. Follow-up was conducted at 1, 3, 6, and 12 months posttreatment with symptom assessments, endoscopy, and functional lumen imaging probe performed at 6 months. Stricture recurrence was defined as a diameter <13 mm on FLIP or any clinically driven reintervention.

RESULTS

Strictures were primarily peptic (88%) with a median of 6 lifetime dilations prior to entry. Freedom from stricture recurrence was 40% (10/25) in the 12 months post-DCB versus an expected 0% based on past history. Symptoms were improved (by DHI and Ogilvie Score) at 12 months. Systemic exposure to paclitaxel was limited, with only 7 subjects showing measurable levels of drug (0.1-0.2 ng/mL) in their blood after treatment. No adverse events were related to the DCB.

CONCLUSIONS

Treatment of esophageal strictures with DCB demonstrated decreased recurrence of significant stricture compared to historical needs, improved dysphagia symptoms compared to baseline, and limited systemic exposure to paclitaxel. Prospective randomized studies are needed to confirm these results.