Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Disease Strictures: The BEST-CD Randomized Trial

Endoscopic balloon dilation (EBD) is the standard therapy for Crohn's disease (CD) strictures but is limited by recurrence and reinterventions. Randomized comparative data on endoscopic stricturotomy (ES) vs EBD are lacking.

In this randomized controlled trial, adults (18-65 years) with symptomatic CD and short (<3 cm) strictures accessible by standard endoscopy were randomly assigned (1:1) to EBD or ES. The primary outcome was clinical recurrence at 1 year. Secondary outcomes at 1 year included reintervention, surgery, and stricture-related emergency visits and hospitalisation; safety was assessed at 30 days. Time-to-event analyses were censored at 12 months.

Of 164 patients screened, 106 were randomised (EBD n=53; ES n=53). In the intention-to-treat population, clinical recurrence at 1 year was lower with ES than EBD (30.1% vs 54.7%; p=0·01), as were reintervention (24.5% vs 49.1%; p=0·01), emergency visits (18.9% vs 50.9%; p=0·001), and hospitalisations (15.1% vs 34%; p=0·02). Surgery did not differ significantly (1.9% vs 11.3%; p=0·11). In 12-month time-to-event analyses, EBD was associated with higher hazards of clinical recurrence (HR 2.27, 95% CI 1.23-4.18) and reintervention (HR 2.40, 95% CI 1.23-4.68), with consistent findings for emergency visits and hospitalisation. Adverse events were similar (13·2% vs 22.6%; p=0·30).

ES was associated with lower 1-year clinical recurrence and reintervention than EBD for short CD strictures. These findings support ES as a promising endoscopic strategy in expert centres and warrant validation in multicentre studies. (ClinicalTrials.gov: NCT05521867).