PaNETh: Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- Clinical Success [2016-2021]
Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.
Secondary Outcome Measures
- Adverse Events [2016-2021]
Incidence of Endoscopic Papillectomy-related adverse events.
- Recurrences [2016-2021]
Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.
- Concordance between pre- and post-Endoscopic Papillectomy pathologic findings [2016-2021]
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
Eligibility Criteria
Criteria
Inclusion Criteria:
- Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen
Exclusion Criteria:
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Absence of dysplasia on the resected specimen;
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Locally advanced or metastatic disease (Clinical TNM stage >T1 or N+ or M+);
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Neoplasm Intra-Ductal Extension (IDE) > 20 mm;
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Previously treated ampullary neoplasm.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ospedale Morgagni-Pierantoni | Forlì | Forlì-Cesena | Italy | 47121 |
Sponsors and Collaborators
- Azienda Unità Sanitaria Locale della Romagna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- ASGE 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.
- 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.
- Fritzsche JA, Klein A, Beekman MJ, van Hooft JE, Sidhu M, Schoeman S, Fockens P, Bourke MJ, Voermans RP. Endoscopic papillectomy; a retrospective international multicenter cohort study with long-term follow-up. Surg Endosc. 2021 Nov;35(11):6259-6267. doi: 10.1007/s00464-020-08126-x. Epub 2020 Nov 6.
- Gondran H, Musquer N, Perez-Cuadrado-Robles E, Deprez PH, Buisson F, Berger A, Cesbron-Metivier E, Wallenhorst T, David N, Cholet F, Perrot B, Queneherve L, Coron E. Efficacy and safety of endoscopic papillectomy: a multicenter, retrospective, cohort study on 227 patients. Therap Adv Gastroenterol. 2022 Apr 22;15:17562848221090820. doi: 10.1177/17562848221090820. eCollection 2022.
- Napoleon 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.
- Spadaccini 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.
- Tringali 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.
- Vanbiervliet 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.
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