| Sumario: | Background: Anorectal stricture is a challenging complication of Crohn's disease (CD). Endoscopic needle-knife stricturotomy (NKSt) has emerged as a minimally invasive treatment option, but its long-term outcomes and factors influencing recurrence remain underexplored. Objectives: This study aimed to prospectively evaluate the long-term efficacy, safety, and risk factors for recurrence after NKSt for primary high-grade anorectal strictures in CD. Design: Single-center prospective cohort study. Methods: Between October 2020 and September 2023, 54 consecutive CD patients with primary high-grade anorectal strictures undergoing NKSt were enrolled. The primary endpoint was stricture recurrence requiring re-intervention. Risk factors were analyzed using univariable and multivariable Cox proportional hazards regression. Recurrence-free survival was estimated with the Kaplan-Meier method. A restricted cubic spline model within the Cox framework was employed to explore the nonlinear relationship between stricture length and recurrence. Results: The median follow-up was 24 months (interquartile range (IQR): 6–43). Immediate technical success was achieved in all patients (100%), and 38 patients (70.4%) reported symptomatic improvement at 3 months. Recurrence occurred in 20 patients (37.0%). Multivariable analysis identified stricture length (hazard ratio (HR) 1.184 per cm increase, 95% confidence interval (CI): 1.015–1.380; p = 0.032), the presence of an ostomy (HR 3.901, 95% CI: 1.406–10.823; p = 0.009), and concurrent biologic therapy (HR 0.177, 95% CI: 0.057–0.546; p = 0.003) as independent predictors of recurrence. In univariable analysis, NKSt combined with bleomycin injection was associated with a lower recurrence risk compared to NKSt alone (p = 0.027). Conclusion: NKSt is an effective and safe treatment for primary high-grade anorectal strictures in CD, although recurrence is common. Stricture length, ostomy status, and the use of biologic agents are independent predictors of recurrence, while concomitant bleomycin injection may reduce recurrence risk. These findings can inform individualized treatment strategies and highlight the need for validation in larger, multicenter trials. Plain language summary: A safe, minimally invasive treatment for severe rectal narrowing in Crohn's disease: long-term study results Severe narrowing in the lower bowel is a difficult complication of Crohn's disease that can cause pain, trouble passing stool, and other problems. Currently, treatment options are limited, and many patients eventually need major surgery. This study wanted to see if NKSt could be a good alternative to help patients avoid such surgery. What did the researchers do? A total of 54 patients with severe narrowing of the anus or rectum due to Crohn's disease were treated with NKSt and then followed for an average of 2 years. The researchers recorded whether the narrowing came back, how patients felt after treatment, and what factors might be linked to recurrence. What did the researchers find? The procedure was technically successful in all patients right away, and about 70% felt much better 3 months later. During follow-up, the narrowing returned in 20 out of 54 patients (about 37%). Three main factors were found to be linked to a higher risk of the narrowing coming back: longer strictures (each extra centimetre increased the risk); having an opening in the abdomen for waste removal (ostomy); not using biologic therapy (using biologics lowered the risk). Injecting a drug called bleomycin during the procedure also appeared to lower the chance of recurrence. No serious side effects related to the procedure were reported. What do the results mean? Endoscopic needle-knife stricturotomy is a safe and effective way to treat severe anorectal narrowing in Crohn's disease. It can improve symptoms and may help many patients avoid major surgery. The study also gives doctors and patients useful information about who might be more likely to need repeat treatment. Using biologic medicines or adding bleomycin during the procedure could help lower the risk of the narrowing coming back. More studies with larger groups of patients are needed to confirm these results.
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