Ampulla of Vater Adenoma, Ampulla of Vater Cancer, Ampullary Adenoma, Ampullary Cancer
Conditions
Keywords
Endoscopic Papillectomy, Ampullary Adenoma, Ampullary Neoplasm
Brief summary
The aim of our study is to provide data on the efficacy and safety of endoscopic papillectomy, by including consecutive patients treated after 2015, when first guidelines on endoscopic management of ampullary neoplasms were available.
Detailed description
Ampullary neoplasm (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. 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.
Interventions
PROCEDUREEndoscopic Papillectomy
Endoscopic resection of ampullary neoplasm
Sponsors
Azienda Unità Sanitaria Locale della Romagna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen
Exclusion criteria
* Absence of dysplasia on the resected specimen; * Locally advanced or metastatic disease (Clinical TNM stage \>T1 or N+ or M+); * Neoplasm Intra-Ductal Extension (IDE) \> 20 mm; * Previously treated ampullary neoplasm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 2016-2021 | Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 2016-2021 | Incidence of Endoscopic Papillectomy-related adverse events. |
| Recurrences | 2016-2021 | Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy. |
| Concordance between pre- and post-Endoscopic Papillectomy pathologic findings | 2016-2021 | Concordance between pre- and post-Endoscopic Papillectomy pathologic findings |
Countries
Italy
Contacts
Primary ContactCarlo Fabbri, MD
Outcome results
None listed