ENDOSCOPIC PAPILLECTOMY: A MULTICENTER, RETROSPECTIVE, NATIONWIDE STUDY AFTER THE STANDARDISATION OF THE TECHNIQUE.

BACKGROUND AND AIMS
Ampullary neoplasia (AN) is a rare disease, but its incidence is increasing. In the last 20 years, endoscopic papillectomy (EP) has become the gold standard treatment for ampullary adenomas and early stage adenocarcinomas, thereby replacing surgical resection, which is burdened by higher rates of morbidity and mortality. However, the data supporting safety and efficacy of EP derive from multiple retrospective studies, that included procedures mostly performed before 2015, when first guidelines on endoscopic management of AN were available. This had an impact on large variability in patient selection criteria and endoscopic techniques, resulting in heterogenous outcomes. Therefore, the aim of our study is to provide data on the efficacy and safety of this technique, by including consecutive patients treated after the standardization of this technique.

METHODS
All patients who underwent EP at 19 Italian centers between January 2016 and December 2021 were included. Clinical success was defined by the complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period. EP-related adverse events and recurrences were recorded.

RESULTS
A total of 225 patients were included. The mean lesion’s size was 20 mm (5–80 mm). En bloc resection was possible in 72.5% of cases, with an overall R0 resection rate of 50.7%. During a mean follow-up period of 23.2 months, recurrences were diagnosed in 17.2% of patients, 61,3% of which were successfully treated with an additional endoscopic treatment. Thus, clinical success was achieved in 76.7% of the cases. In multivariate analysis, R1 resection, lesion size and histological diagnosis were predictors for recurrence. Intra-procedural bleeding occurred during 12,4% of EP. Post-EP adverse events (AE) occurred in 39,5% of patients, including delayed bleeding (20,9%), pancreatitis (13.3%) and perforation (2.2%). Complications were mild or moderate in 88,9%, while the 11.1% were severe, according the ASGE Lexicon. No EP-related deaths were recorded.

CONCLUSIONS
The results of our study confirm the efficacy of endoscopic papillectomy in the treatment of ampulla of Vater neoplasms in the current clinical practice. Most of recurrences were successfully endoscopically managed. However, even if performed by expert endoscopists, EP is a procedure associated with not negligible risk of complications.