Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures

Post written by Bo Shen, MD, from Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, New York, New York, USA.

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Benign and malignant primary (ie, disease-associated) or anastomotic strictures in the lower GI tract are common in gastroenterology.

The focus of this article is the endoscopic treatment of benign primary or anastomotic strictures (eg, diverticular diseases). The main endoscopy treatment modality is mechanical endoscopic balloon dilation and endoscopic electroincision with stricturotomy.

However, most of those strictures require repeat endoscopic intervention, and some may be infeasible for surgical intervention because of the risk of postoperative recurrence of stricture and adverse events.

The concept and technology of drug-coated balloons have been applied in the routine management of cardiovascular and urological strictures. Paclitaxel has an antiproliferative effect to reduce the rate of restenosis of treated strictures. This case series demonstrates the feasibility, efficacy, and safety of drug-coated balloons. 

The management of primary or anastomotic benign strictures in the lower GI tract has been challenging. The most common benign lower GI tract strictures are seen in Crohn’s disease (CD). Medical, endoscopic, and surgical therapies have been used for the treatment of CD-associated strictures. Medical therapy has a limited role in the treatment of CD. Endoscopic mechanical balloon dilation and endoscopic stricturotomy provide less invasive yet effective therapy compared with surgical resection or stricturoplasty for CD strictures.  

Yet, restenosis of the strictures after dilation with the bare balloon is common, requiring repeat endoscopic therapy. Dilation of the strictures with a drug-coated balloon may be more effective than a bare balloon by reducing the interval between endoscopic interventions.

This study of 10 patients showed that dilation of benign primary or anastomotic strictures of the small and large bowels with drug-coated balloons is feasible with a technical success of 90% and appears to be effective in reducing patients’ symptoms and endoscopic obstruction scores. The procedure was well tolerated. With the success and outcome of similar technology in cardiovascular and urological stenosis, dilation of strictures with the drug-coated balloon holds a promising future.

Currently, the same kind of balloon is on clinical trial in the United States (Clinical trial registration number: NCT05561127).

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Average Endoscopic Obstruction Score at baseline versus at 6 months.

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