Ampullary AdenomaPaNEThNCT05690412
Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms.
An observational study of Ampullary Adenoma and Ampulla of Vater Adenoma, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ampullary Adenoma, Ampulla of Vater Adenoma, Ampullary Cancer
- What is being tested?
- Endoscopic Papillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who underwent Endoscopic Papillectomy for Ampullary Neoplasm at 19 Italian centers, between January 2016 and December 2021.
Who may be able to join
- Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Morgagni-Pierantoni
Forlì, Forlì-Cesena, 47121
Carlo Fabbri, MD
About this study
Official title: Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
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.
Read the 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.
- Being tested
- Endoscopic Papillectomy
- Keywords
- Endoscopic Papillectomy, Ampullary Adenoma, Ampullary Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic PapillectomyProcedure or surgery
Endoscopic resection of ampullary neoplasm
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.
Measured: 2016-2021
Secondary outcomes (3)
Adverse Events
Incidence of Endoscopic Papillectomy-related adverse events.
Measured: 2016-2021
Recurrences
Incidence of neoplastic recurrences in the follow-up period, after Endoscopic Papillectomy.
Measured: 2016-2021
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Apr 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ampullary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unità Sanitaria Locale della Romagna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Fabbri, Azienda Unità Sanitaria Locale della Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690412
- Sponsor's protocol ID
- 2828
- Acronym
- PaNETh
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26260385Vanbiervliet 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.
PubMed 33728632Spadaccini 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.
PubMed 32213054Napoleon 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.
PubMed 24477368Tringali 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.
PubMed 32532606Cecinato 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.
PubMed 31898110Fritzsche 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.
PubMed 33159297Gondran 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. Ther Adv Gastroenterol. 2022 Apr 22;15:17562848221090820. doi: 10.1177/17562848221090820. eCollection 2022.
PubMed 35480299
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Papillectomy in the Treatment of Ampullary Neoplasms: a Multicenter, Retrospective, Nationwide Study.
- ClinicalTrials.gov ID
- NCT05690412
- Acronym / sponsor ID
- PaNETh / 2828
- Keywords
- Endoscopic Papillectomy, Ampullary Adenoma, Ampullary Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azienda Unità Sanitaria Locale della RomagnaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent Endoscopic Papillectomy for Ampullary Neoplasm at 19 Italian centers, between January 2016 and December 2021.
Key inclusion criteria (1 listed)
- Ampullary neoplasm, confirmed by histological examination of the endoscopically resected specimen
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic PapillectomyEndoscopic resection of ampullary neoplasm | Procedure or surgery | – |
Primary outcome
Clinical Success
Time frame: 2016-2021
Complete endoscopic management of the neoplasm and any eventual recurrence found in the follow-up period.
3 secondary outcomes
Adverse Events
Time frame: 2016-2021
Recurrences
Time frame: 2016-2021
Concordance between pre- and post-Endoscopic Papillectomy pathologic findings
Time frame: 2016-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Background: PubMed 26260385ASGE 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.
- Background: PubMed 33728632Vanbiervliet 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.
- Background: PubMed 32213054Spadaccini 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.
- Background: PubMed 24477368Napoleon 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.
- Background: PubMed 32532606Tringali 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.
- Background: PubMed 31898110Cecinato 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.
- Background: PubMed 33159297Fritzsche 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.
- Background: PubMed 35480299Gondran 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. Ther Adv Gastroenterol. 2022 Apr 22;15:17562848221090820. doi: 10.1177/17562848221090820. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ampullary Adenoma and Ampulla of Vater Adenoma, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Fabbri, MD (3389353104 ext. +39, carlo.fabbri@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: 2016-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690412, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.