Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690412
Status:
RECRUITING
Last Update Posted:
2023-01-23
First Post:
2023-01-10
Brief Title:
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms
Sponsor:
Azienda Unità Sanitaria Locale della Romagna
Organization:
Azienda Unità Sanitaria Locale della Romagna
Study Overview
Official Title:
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms a Multicenter Retrospective Nationwide Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PaNETh
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None