Endoscopic Papillectomy for Ampullary Adenomas
Papillectomy
1 other identifier
observational
62
0 countries
N/A
Brief Summary
In this single-center experience we retrospectively evaluated principal clinical outcomes of endoscopic papillectomy in all patients referred to our unit. The same evaluation was then performed dividing sproradic ampullary adenoma from familial adenomatous polyposis associated adenomas, and resulting outcomes were compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedJune 11, 2025
April 1, 2018
11 years
April 4, 2018
June 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
technical success
The primary outcome of the study was the technical success of endoscopic papillectomy, considered as achieved when all the following criteria were met: a) complete removal, even in multiple sessions b) absence of residues at histology (histology \<= pT1) at the first follow-up; c) recurrence successful treated by endoscopy (not surgery). Technical failure of EP was considered when at least one of the following criteria was met: a) histology\> pT1; b) residual adenomatous tissue not suitable of endoscopic resection; c) recurrence treated by surgery
24 months
Secondary Outcomes (4)
number of procedures to achieve technical success
24 months
incidence of adverse events
24 months
incidence of recurrence
24 months
concordance of histology pre- and post endoscopi papillectomy
24 months
Interventions
Endoscopic resection of ampullary of Vater neoplasms
Eligibility Criteria
All consecutive patients who underwent endoscopi papillectomy because of ampullary tumor at Arcispedale Santa Maria Nuova
You may qualify if:
- Patients with diagnosis of ampullary adenoma on the endoscopic resection specimen and with at least 24 months of follow-up were included in the analysis
You may not qualify if:
- Patients taht underwent endoscopic papillectomy without a diagnosis of adenoma or adenocarcinoma in the specimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Cecinato P, Parmeggiani F, Braglia L, Carlinfante G, Zecchini R, Decembrino F, Iori V, Sereni G, Tioli C, Cavina M, Camellini L, Azzolini F, Ponz de Leon M, Sassatelli R. Endoscopic Papillectomy for Ampullary Adenomas: Different Outcomes in Sporadic Tumors and Those Associated with Familial Adenomatous Polyposis. J Gastrointest Surg. 2021 Feb;25(2):457-466. doi: 10.1007/s11605-019-04500-w. Epub 2020 Jan 2.
PMID: 31898110DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Romano Sassatelli, MD
Azienda USL Reggio Emilia - IRCCS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2018
First Posted
April 11, 2018
Study Start
January 1, 2005
Primary Completion
December 31, 2015
Study Completion
December 31, 2017
Last Updated
June 11, 2025
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share