Familial Adenomatous Polyposis Clinical Trial
— PapillectomyOfficial title:
Endoscopic Papillectomy for Ampullary Adenomas: an Italian Single Centre Experience
Verified date | April 2018 |
Source | Arcispedale Santa Maria Nuova-IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients taht underwent endoscopic papillectomy without a diagnosis of adenoma or adenocarcinoma in the specimen |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Arcispedale Santa Maria Nuova-IRCCS |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | number of procedures to achieve technical success | number of procedures to achieve technical success | 24 months | |
Secondary | incidence of adverse events | incidence of adverse events | 24 months | |
Secondary | incidence of recurrence | incidence of recurrence | 24 months | |
Secondary | concordance of histology pre- and post endoscopi papillectomy | concordance of histology pre- and post endoscopi papillectomy | 24 months |
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