Refractory bleeding after endoscopic sphincterotomy: a new indication for recombinant factor VII therapy?

The therapeutic approach in post-ERCP bleeding depends on the severity of the episode. In most instances early bleeding is self-limited, but when it is severe enough endoscopic injection of epinephrine (EP) is the usual treatment. Nevertheless, in some cases bleeding relapses, whereas in between 5% and 10% of patients the refractoriness to endoscopic management may even be fatal and other therapeutic alternatives would be needed. Otherwise, in a small subgroup of cases the bleeding becomes massive, the vision is obscured, and the injection may be very difficult in a situation of hemodynamic instability. We here report a case of refractory post-endoscopic sphincterotomy (ES) bleeding in a patient without preexisting coagulopathy, successfully treated with a single injection of rFVII. This novel experience suggests that rFVIIa, besides its actual high costs, might be useful and safe as a second-line, noninvasive, therapeutic tool in selected cases of massive, or refractory, post-ES bleeding.