Step-Up Strategy for Endoscopic Hemostasis Using PuraStat After Endoscopic Sphincterotomy Bleeding (STOP Trial)

Background and Aims

Recently, a novel self-assembling peptide hemostatic gel (PuraStat) has become available. Although PuraStat for endoscopic sphincterotomy (EST) bleeding has been evaluated and reported mainly in case reports and several retrospective studies, no prospective evaluation has been reported. The aim of the present study was to prospectively evaluate the safety and efficacy of PuraStat for persistent EST bleeding >120 seconds as a first-line endoscopic hemostasis technique.

Methods

This single-arm, prospective study was conducted between November 2022 and August 2023. As the primary technique for endoscopic hemostasis, PuraStat was applied first. If hemostasis failed, other techniques were used. The primary outcome of the present study was to evaluate the technical success rate of the application of PuraStat to the bleeding site. Clinical success was defined as the absence of oozing for 180 seconds after PuraStat application. Adverse events associated with procedures and secondary hemorrhage were secondary outcomes. PuraStat application was performed using the embankment method.

Results

During the study period, 1080 endoscopic retrograde cholangiopancreatography procedures were performed. A total of 108 patients experienced complications with EST bleeding. Among them, endoscopic hemostasis was required in 51 patients. These patients enrolled in this prospective study. All patients successfully underwent PuraStat application without PuraStat dislocation into the third part of the duodenum. The technical success rate of endoscopic hemostasis using PuraStat was 98% (50/51). As possible factors associated with secondary hemorrhage, biliary stents, including plastic or metal stents, were deployed in 60.7% (31/51). Finally, severe adverse events associated with the procedures were not observed in any patients, although mild acute pancreatitis was observed in 2 patients, and conservative treatment was successful.

Conclusion

In conclusion, PuraStat application may be safe for oozing after EST without increasing the frequency of acute pancreatitis.