Clinical trial NCT05690412: Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
Official title: Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ampullary Adenoma
Ampulla of Vater Adenoma
Ampullary Cancer
Ampulla of Vater Cancer
Keywords: Endoscopic Papillectomy
Ampullary Adenoma
Ampullary Neoplasm
Lead sponsor: Azienda Unità Sanitaria Locale della Romagna
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent Endoscopic Papillectomy for Ampullary Neoplasm at 19 Italian centers, between January 2016 and December 2021.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: 2016-2021
Secondary outcomes:
measure: Adverse Events
timeFrame: 2016-2021
measure: Recurrences
timeFrame: 2016-2021
measure: Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
timeFrame: 2016-2021
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
state: Forlì-Cesena
Study officials:
References:
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