NCT05690412

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 10, 2023

Last Update Submit

January 20, 2023

Conditions

Ampullary AdenomaAmpulla of Vater AdenomaAmpullary CancerAmpulla of Vater Cancer

Keywords

Endoscopic PapillectomyAmpullary AdenomaAmpullary Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Clinical Success

    Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.

    2016-2021

Secondary Outcomes (3)

  • Adverse Events

    2016-2021

  • Recurrences

    2016-2021

  • Concordance between pre- and post-Endoscopic Papillectomy pathologic findings

    2016-2021

Interventions

Endoscopic PapillectomyPROCEDURE

Endoscopic resection of ampullary neoplasm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients who underwent Endoscopic Papillectomy for Ampullary Neoplasm at 19 Italian centers, between January 2016 and December 2021.

You may qualify if:

  • Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, 47121, Italy

RECRUITING

Related 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.

    PMID: 26260385BACKGROUND

  • 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.

    PMID: 33728632BACKGROUND

  • 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.

    PMID: 32213054BACKGROUND

  • 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.

    PMID: 24477368BACKGROUND

  • 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.

    PMID: 32532606BACKGROUND

  • 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.

    PMID: 31898110BACKGROUND

  • 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.

    PMID: 33159297BACKGROUND

  • 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.

    PMID: 35480299BACKGROUND

Central Study Contacts

Carlo Fabbri, MD

CONTACT

3389353104carlo.fabbri@auslromagna.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

April 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

IT(1)