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

January 20, 2023 updated by: Carlo Fabbri, Azienda Unità Sanitaria Locale della Romagna

Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Forlì-Cesena
      • Forlì, Forlì-Cesena, Italy, 47121
        • Recruiting
        • Ospedale Morgagni-Pierantoni
        • Contact:
          • Carlo Fabbri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success
Time Frame: 2016-2021
Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.
2016-2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 2016-2021
Incidence of Endoscopic Papillectomy-related adverse events.
2016-2021
Recurrences
Time Frame: 2016-2021
Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.
2016-2021
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
Time Frame: 2016-2021
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
2016-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale della Romagna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2828

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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