Trials / Unknown
UnknownNCT05690412
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Azienda Unità Sanitaria Locale della Romagna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic Papillectomy | Endoscopic resection of ampullary neoplasm |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
- First posted
- 2023-01-19
- Last updated
- 2023-01-23
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05690412. Inclusion in this directory is not an endorsement.