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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-03-31

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.

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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.

Conditions

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Ampullary Adenoma Ampulla of Vater Adenoma Ampullary Cancer Ampulla of Vater Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Endoscopic Papillectomy

Endoscopic resection of ampullary neoplasm

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No