Comparing endoscopic intervention against fully covered self-expanding metal stent placement for post-endoscopic sphincterotomy bleed (CEASE Study)

Background and study aims: Limited data exist for the use of fully covered self-expanding metal stent (FCSEMS) as an intervention for immediate bleeds post-endoscopic sphincterotomy (ES) after primary endoscopic intervention failure or to reduce the number of delayed bleeding events in patient with increased risk of bleeding post-ES. Patients and methods: We evaluated a retrospective cohort of individuals who had ES performed from 2011 to 2014. A total of 700 patients were identified with 67 patients having post-ES bleeding. The FCSEMS treatment group included 23 patients and the non-FCSEMS treatment group included 44 patients. The primary end point was rate of change of Hgb at 72 hours after ES in the FCSEMS group and the primary endoscopic intervention-only group. A comparison also was made between the FCSEMS and non-FCSEMS group with regards to proportion of coagulopathy and number of delayed bleeding events. Results: The FCSEMS treatment group had a lower bleeding rate at 72 hours (0.66 g/dL vs 1.98 g/dL P < 0.001), increased proportion of patients at high risk of bleeding (40 % vs 9 % P value 0.008), and increased frequency of bleeding events that were moderately severe (52 % vs 9 % P = 0.0002) compared to the non-FCSEMS treatment group. The FCSEMS group included 9 patients at increased risk of bleeding and no patients with delayed bleed compared to the non-FCSEMS group, in which all 4 patients at increased risk of bleeding developed a delayed bleed. Conclusion: FCSEMS can provide homeostasis after primary endoscopic intervention failure, thus reducing the need for high-risk procedures. FCSEMS can reduce delayed bleeding events in patients at high risk of post-ES bleeding.