P649 Long-term follow-up of the PROTDILAT study; LONG-PROTDILAT Prospective multicenter randomized comparative study of endoscopic treatment of strictures in Crohn's disease (CD): self-expandable metal stent (SEMS) vs endoscopic balloon dilatation (EBD)
Authors: Ruiz Ramírez P , Loras C , Gornals J , Maia Bosca-Watts M , Brunet E , Iglesias E , Barrio J , Sicilia B , Dueñas C , Foruny J R , Martín-Arranz M D , Busquets D , Cerrillo E , García Morales N , Monfort D , Pérez-Roldán F , Pijoan E , González B , Reyes J , Torres G , Maristany E , Sanchiz V , Guardiola J , Esteve M 
Published: January 2024

Abstract

Background
The PROTDILAT study (Loras et al. Lancet Gastroenterol Hepatol.2022) at 1-year follow-up showed greater efficacy of EBD vs SEMS for the treatment of short strictures in CD.

Aims
To assess the long-term evolution of patients included in PROTDILAT study. 1)Percentage of patients free of surgery; 2)Factors related to surgery; 3)Need for endoscopic retreatments; 4)Effectiveness related to the type of initial endoscopic treatment (EBD vs SEMS); 5)Complications related to endoscopic or surgical treatment.

Methods
Retrospective study based on PROTDILAT trial database (patients with CD, obstructive symptoms, with stenosis &lt;10cm). Data on medical, endoscopic and surgical treatment and smoking habits were collected. The effectiveness of endoscopic treatment is defined by the percentage of patients free of surgery and endoscopic retreatment at the end of follow-up.

Results
Information available on 80/80 patients (39 SEMS, 41 EBD), 39 women, age (median): 45y (IQR: 38-55); median stricture length 3.4cm (IQR: 2-5.5), 42.5% being anastomotic. Thirty percent (24/80) of patients required surgical resection [(median time to surgery 27.88 months (5.89-52.39)]. Factors associated to surgery: non- intensification of therapy (HR 0.23 (0.09-063)), treatment with EBD (HR 0.24 (0.09-0.7)) (with respect to treatment with EBD + SEMS) and number of stents (HR 2.88 (1.14-7.27)). Of the 56 patients free of surgery, during the entire follow-up (median 84 months (74.7-84.0)), a median of 2 endoscopic procedures (1-3) were performed: EBD in 45 cases (80.0%) and SEMS in 26 cases (46%). Thirty-eight-point seventy-five percent (31/80 patients) did not require neither surgery nor endoscopic retreatment during the follow-up. Out of 44/80 patients (16 SEMS vs 28 EBD) with primary treatment success in PROTDILAT study (1 year of follow-up) that not required surgery, the long-term effectiveness of endoscopic treatment was 56% for SEMS and 68% for EBD (p=0.4). The complications related to endoscopic or surgical treatment were 8.75% (7/80) versus 37.5% (9/24) respectively (p=0.002).

Conclusion
Endoscopic treatment (predominantly EBD) avoids surgery in most cases, requiring a low number of endoscopic treatments in the long-term. Patients at higher risk for surgery are those with a greater number of endoscopic treatments that include SEMS and EBD. On the contrary, protective factors are non-intensification of therapy and having been treated exclusively with EBD. Although there are no significant differences in the long effectiveness between SEMS and EBD, a trend for a better outcome is observed for EBD. To highlight a significant higher rate of complications observed in surgical treatment compared to endoscopic treatment.