Clinical trial · Observational
Endoscopic Papillectomy for Ampullary Adenomas
Endoscopic Papillectomy for Ampullary Adenomas: an Italian Single Centre Experience
NCT03494543CI-TRIAL-00090854PapillectomycompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Papillectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- technical success
- timeFrame
- 24 months
- description
- 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
Secondary outcomes (4)
- measure
- number of procedures to achieve technical success
- timeFrame
- 24 months
- description
- number of procedures to achieve technical success
- measure
- incidence of adverse events
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCecinato 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 31898110