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

Recruiting

• Conditions: Ampulla of Vater Adenoma; Ampulla of Vater Cancer; Ampullary Adenoma; Ampullary Cancer

• Registration Number: NCT05690412
• Lead Sponsor: Azienda Unità Sanitaria Locale della Romagna

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.

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Success	2016-2021	Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Forlì-Cesena, Italy