Clinical trial · Observational
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
NCT05690412CI-TRIAL-00063386PaNEThunknownClinicalTrials.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)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
| Ampulla of Vater Cancer | Malignant Ampulla of Vater Neoplasm | CURATED_BROADER | 0.80 |
| Ampullary Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Papillectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical Success
- timeFrame
- 2016-2021
- description
- Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.
Secondary outcomes (3)
- measure
- Adverse Events
- timeFrame
- 2016-2021
- description
- Incidence of Endoscopic Papillectomy-related adverse events.
- measure
- Recurrences
- timeFrame
- 2016-2021
- description
- Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDASGE Standards of Practice Committee; Chathadi KV, Khashab MA, Acosta RD, Chandrasekhara V, Eloubeidi MA, Faulx AL, Fonkalsrud L, Lightdale JR, Salztman JR, Shaukat A, Wang A, Cash BD, DeWitt JM. The role of endoscopy in ampullary and duodenal adenomas. Gastrointest Endosc. 2015 Nov;82(5):773-81. doi: 10.1016/j.gie.2015.06.027. Epub 2015 Aug 7. No abstract available. PMID 26260385
- BACKGROUNDVanbiervliet G, Strijker M, Arvanitakis M, Aelvoet A, Arnelo U, Beyna T, Busch O, Deprez PH, Kunovsky L, Larghi A, Manes G, Moss A, Napoleon B, Nayar M, Perez-Cuadrado-Robles E, Seewald S, Barthet M, van Hooft JE. Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Apr;53(4):429-448. doi: 10.1055/a-1397-3198. Epub 2021 Mar 16. PMID 33728632
- BACKGROUNDSpadaccini M, Fugazza A, Frazzoni L, Leo MD, Auriemma F, Carrara S, Maselli R, Galtieri PA, Chandrasekar VT, Fuccio L, Aljahdli E, Hassan C, Sharma P, Anderloni A, Repici A. Endoscopic papillectomy for neoplastic ampullary lesions: A systematic review with pooled analysis. United European Gastroenterol J. 2020 Feb;8(1):44-51. doi: 10.1177/2050640619868367. Epub 2019 Jul 30. PMID 32213054
- BACKGROUNDNapoleon B, Gincul R, Ponchon T, Berthiller J, Escourrou J, Canard JM, Boyer J, Barthet M, Ponsot P, Laugier R, Helbert T, Coumaros D, Scoazec JY, Mion F, Saurin JC; Societe Francaise d'Endoscopie Digestive (SFED, French Society of Digestive Endoscopy). Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study. Endoscopy. 2014 Feb;46(2):127-34. doi: 10.1055/s-0034-1364875. Epub 2014 Jan 29. PMID 24477368
- BACKGROUNDTringali A, Valerii G, Boskoski I, Familiari P, Landi R, Perri V, Costamagna G. Endoscopic snare papillectomy for adenoma of the ampulla of vater: Long-term results in 135 consecutive patients. Dig Liver Dis. 2020 Sep;52(9):1033-1038. doi: 10.1016/j.dld.2020.05.029. Epub 2020 Jun 10. PMID 32532606
- 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.