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Trial Title:
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
NCT ID:
NCT05690412
Condition:
Ampullary Adenoma
Ampulla of Vater Adenoma
Ampullary Cancer
Ampulla of Vater Cancer
Conditions: Official terms:
Neoplasms
Adenoma
Conditions: Keywords:
Endoscopic Papillectomy
Ampullary Adenoma
Ampullary Neoplasm
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic Papillectomy
Description:
Endoscopic resection of ampullary neoplasm
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.
Criteria for eligibility:
Study pop:
All consecutive patients who underwent Endoscopic Papillectomy for Ampullary Neoplasm at
19 Italian centers, between January 2016 and December 2021.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale Morgagni-Pierantoni
Address:
City:
Forlì
Zip:
47121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Fabbri, MD
Start date:
April 1, 2022
Completion date:
March 31, 2023
Lead sponsor:
Agency:
Azienda Unità Sanitaria Locale della Romagna
Agency class:
Other
Source:
Azienda Unità Sanitaria Locale della Romagna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690412
