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

Sponsor
Azienda Unità Sanitaria Locale della Romagna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05690412
Collaborator
(none)
400
1
12
33.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic Papillectomy

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Clinical Success [2016-2021]

    Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.

Secondary Outcome Measures

  1. Adverse Events [2016-2021]

    Incidence of Endoscopic Papillectomy-related adverse events.

  2. Recurrences [2016-2021]

    Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.

  3. Concordance between pre- and post-Endoscopic Papillectomy pathologic findings [2016-2021]

    Concordance between pre- and post-Endoscopic Papillectomy pathologic findings

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Morgagni-Pierantoni Forlì Forlì-Cesena Italy 47121

Sponsors and Collaborators

  • Azienda Unità Sanitaria Locale della Romagna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carlo Fabbri, Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, Azienda Unità Sanitaria Locale della Romagna
ClinicalTrials.gov Identifier:
NCT05690412
Other Study ID Numbers:
  • 2828
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carlo Fabbri, Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, Azienda Unità Sanitaria Locale della Romagna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2023