Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.

Conditions
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Ampullary Adenoma, Ampulla of Vater Adenoma, Ampullary Cancer, Ampulla of Vater Cancer

Intervention / Treatment
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* Procedure: Endoscopic Papillectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Papillectomy|Endoscopic resection of ampullary neoplasm|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period. | 2016-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of Endoscopic Papillectomy-related adverse events. | 2016-2021 | 
| Recurrences | Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy. | 2016-2021 | 
| Concordance between pre- and post-Endoscopic Papillectomy pathologic findings | Concordance between pre- and post-Endoscopic Papillectomy pathologic findings | 2016-2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Papillectomy, Ampullary Adenoma, Ampullary Neoplasm