Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.

Ampullary Cancer Clinical Trial

— PaNETh  

Official title:

Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690412
• Other study ID #: 2828
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2023
• Source: Azienda Unità Sanitaria Locale della Romagna
• Contact: Carlo Fabbri, MD
• Phone: 3389353104
• Email: carlo.fabbri[@]auslromagna.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Ampulla of Vater Adenoma
• Ampulla of Vater Cancer
• Ampullary Adenoma
• Ampullary Cancer
• Neoplasms

Intervention

Procedure:
• Endoscopic Papillectomy
Endoscopic resection of ampullary neoplasm

Locations

Country	Name	City	State
Italy	Ospedale Morgagni-Pierantoni	Forlì	Forlì-Cesena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale della Romagna

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.	2016-2021
Secondary	Adverse Events	Incidence of Endoscopic Papillectomy-related adverse events.	2016-2021
Secondary	Recurrences	Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.	2016-2021
Secondary	Concordance between pre- and post-Endoscopic Papillectomy pathologic findings	Concordance between pre- and post-Endoscopic Papillectomy pathologic findings	2016-2021