Se lf- expandable metal stents versus endoscopic balloon dilatation for the treatment of strictures in Crohn’s disease: a retrospective lo ng- term foll ow- up of the ProtDilat study, an open label, multicenter, randomized trial

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BACKGROUND: At 1-year of follow-up, the ProtDilat trial indicated that endoscopic balloon dilatation (EBD) was more effective than self-expandable metal stents (SEMSs) for treating Crohn's disease (CD) strictures. We aimed to assess the long-term outcomes of ProtDilat participants, focusing on surgery-free rates, factors related to surgery, and endoscopic retreatment. METHODS: We retrospectively collected data on medical treatment, endoscopic-surgical interventions, and smoking status. The primary outcome was the percentage of patients who remained free of surgery at the end of follow-up. RESULTS: Eighty participants were included (39 SEMS, 41 EBD); 39 were women and the median age was 45 years (IQR: 38-55). Over a 7-year follow-up (median 77 months; IQR 61-84), 31.5% (25/80) of patients required surgery, with a median time to surgery of 30.6 months (IQR 6.4-55.2). Surgery-protective factors were no-intensification of medical therapy (HR 0.22 [0.08-0.58]), EBD treatment (HR 0.26 [0.10-0.68]), and single endoscopic treatment (HR 0.33 [0.15-0.74]). Among the 55 patients who avoided surgery, the median number of endoscopic treatments was two. Notably, 36.3% (29/80) required neither surgery nor endoscopic retreatment. Among the 53 patients (20 SEMS vs 33 EBD) with successful initial endoscopic treatment in the ProtDilat, the long-term effectiveness (free of surgery and endoscopic retreatment) was 45% and 57.6% respectively (P = .374). Treatment-related adverse events occurred in 8.75% (7/80) of endoscopic cases vs 36% (9/25) of surgical cases (P = .003), with a severity (AGREE/Clavien-Dindo ≥ 3) of 38% (3/8) vs 84% (10/12), respectively (P = .011). CONCLUSIONS: Endoscopic approaches (especially EBD) are effective long-term therapies for avoiding surgery and requiring few endoscopic treatments. Stable medical management and single EBD therapy were independently associated with a lower likelihood of surgery during follow-up. Our findings also highlight the higher frequency and severity of adverse events associated with surgical intervention compared to endoscopic management.