Introduction
Endoscopic Papillectomy (EP) represents the gold standard treatment for ampullary adenoma. Despite high rates of clinical success, EP is still burdened by a non-negligible rate of adverse events, with bleeding being one of the most frequent, with a reported pooled rate of 10.6%. Despite differences in presentation and in severity, the majority of the EP-related bleeding can be managed endoscopically. Various techniques, including epinephrine injection, argon plasma coagulation (APC), hemoclips, biliary stents have been employed to manage bleeding, but robust evidence supporting their efficacy are still lacking. Recently, the introduction of a novel haemostatic peptide gel has expanded the toolbox of endoscopic haemostatic agents.
Aims & Methods
This study aims to evaluate the safety and efficacy of this new haemostatic agent in controlling bleeding in patients undergoing EP. This is a multicenter, retrospective study from 4 high-volume centers in Italy, including all consecutive patients treated with the novel heamostatic peptide gel for the management of active EP-related bleeding, between 2019 and 2024. Clinical success was defined as the achievement of hemostasis using the hemostatic gel, either alone or in combination with other techniques, for the treatment of active intraprocedural or delayed EP-related bleeding, without subsequent rebleeding
Results
A total of 16 patients were included in the study. In 15 patients, haemostatic gel was used to manage intraprocedural bleeding, while one patient was treated for delayed bleeding. An oozing bleeding was shown in 13 cases, a spurting bleeding in one case, while in 3 cases no active bleeding was present, although a visible vessels was found in two patients and one ulcer with an adherent clot in one case. Six patients were treated exclusively with haemostatic gel, while the remaining patients received combination treatments, including epinephrine injection (5 cases), clipping (6 cases), biliary stenting (2 cases), and fibrin glue application (1 case). The application of hemostatic gel was successful in 100% of cases, despite the use of side-viewing duodenoscopes with elevator. Clinical success of haemostatic gel application after the first bleeding episode was achieved in 75% (12/16) of patients. However, 4 out of 16 patients (25%) experienced rebleeding within one day after the first treatment. The severity of bleeding ranged from mild to moderate, effectively controlled endoscopically in all cases except one, in which a radiologic embolization was needed in order to achieve bleed control and was therefore classified as severe. No gel-related adverse events were reported.
Conclusion
This novel peptide gel could represent a promising and safe tool to manage active bleeding related to EP. Further prospective studies are needed to confirm its efficacy.
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