Ampulla of Vater AdenomaNCT06648746
Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
An observational study of Ampulla of Vater Adenoma and Ampulla of Vater Disease (Benign/Malignancy), run by Universidade do Porto.
Trial summary
Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ampulla of Vater Adenoma, Ampulla of Vater Disease (Benign/Malignancy)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2024
- 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: Consecutive adult patients submihed to endoscopic resection of an ampullary adenoma in each of the participating center (ULS de Santo António - Porto; ULS São João - Porto)
Who may be able to join
- Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:
- lesions up to 30 mm (including with laterally spreading component)
- with low-grade or high-grade dysplasia on preprocedural histology
- with no intraductal extension
- with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)
- A minimum follow-up period of one year afer endoscopic ampullary resection.
Who cannot join
- Patients with lesions with the following features were excluded:
- intraductal extension
- evidence of invasive malignancy
- other non-adenomatous lesions
- Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
- Patients with a follow-up of less than a year after endoscopic ampullary resection
- Patients with pancreas divisum.
Trial locations and contacts
No sites are listed yet.
About this study
Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.
Nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.
Read the detailed description
The relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure.
The occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. Thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ampullectomy | Consecutive adult patients submitted to endoscopic resection of an ampullary adenoma in each of the participating center for which endoscopic ampullectomy was performed from 1st January 2019 to 31th December will be included. Clinical and demographic data related to the patient, and data pertaining to the ampullary lesion and the endoscopic ampullectomy procedure will be obtained by reviewing the medical records of each participating center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic success
- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
Measured: 1 year
Safety outcomes
- Rate of adverse events related to endoscopic resection of ampullary adenomas
Measured: 1 year
Secondary outcomes (2)
Prophylaxis
- Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis
Measured: 1 year
Risk factors
To perform a multivariate analysis of patient, lesion and procedure characteristics that correlate with the incidence of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ampulla of Vater 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Sérgio Durão Salgueiro, Universidade do Porto
- Investigators
- Paulo Salgueiro, MD, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648746
- Sponsor's protocol ID
- 112233
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Walter D, Schnitzbauer AA, Schulze F, Trojan J. The Diagnosis and Treatment of Ampullary Carcinoma. Dtsch Arztebl Int. 2023 Oct 27;120(43):729-735. doi: 10.3238/arztebl.m2023.0195.
PubMed 37656482Vanbiervliet 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 33728632Shahzad MI, Pickering G, Zafar M, Hayat S, Vlavianos P. The Duodenal Accessory Ampulloma and the Role of Endoscopic Retrograde Cholangiopancreatography (ERCP) in Familial Adenomatous Polyposis Coli Inheritance. Cureus. 2024 May 1;16(5):e59445. doi: 10.7759/cureus.59445. eCollection 2024 May.
PubMed 38826909Rizzo A, Dadduzio V, Lombardi L, Ricci AD, Gadaleta-Caldarola G. Ampullary Carcinoma: An Overview of a Rare Entity and Discussion of Current and Future Therapeutic Challenges. Curr Oncol. 2021 Sep 1;28(5):3393-3402. doi: 10.3390/curroncol28050293.
PubMed 34590592Poley JW, Campos S. Methods and outcome of the endoscopic treatment of ampullary tumors. Ther Adv Gastrointest Endosc. 2020 Jan 21;13:2631774519899786. doi: 10.1177/2631774519899786. eCollection 2020 Jan-Dec.
PubMed 32030370Patel R, Varadarajulu S, Wilcox CM. Endoscopic ampullectomy: techniques and outcomes. J Clin Gastroenterol. 2012 Jan;46(1):8-15. doi: 10.1097/MCG.0b013e318233a844.
PubMed 22064552Maselli R, de Sire R, Fugazza A, Spadaccini M, Colombo M, Capogreco A, Beyna T, Repici A. Updates on the Management of Ampullary Neoplastic Lesions. Diagnostics (Basel). 2023 Oct 6;13(19):3138. doi: 10.3390/diagnostics13193138.
PubMed 37835881Lai JH, Shyr YM, Wang SE. Ampullectomy versus pancreaticoduodenectomy for ampullary tumors. J Chin Med Assoc. 2015 Jun;78(6):339-44. doi: 10.1016/j.jcma.2015.02.002. Epub 2015 Mar 26.
PubMed 25818543Klair JS, Irani S, Kozarek R. Best techniques for endoscopic ampullectomy. Curr Opin Gastroenterol. 2020 Sep;36(5):385-392. doi: 10.1097/MOG.0000000000000657.
PubMed 32740000Kim AL, Choi YI. Safety of duodenal ampullectomy for benign periampullary tumors. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):146-150. doi: 10.14701/ahbps.2017.21.3.146. Epub 2017 Aug 31.
PubMed 28990001Jung YK, Paik SS, Choi D, Lee KG. Transduodenal ampullectomy for ampullary tumor. Asian J Surg. 2021 May;44(5):723-729. doi: 10.1016/j.asjsur.2020.12.021. Epub 2021 Jan 21.
PubMed 33485767Jiang L, Chai N, Li M, Linghu E. Therapeutic Outcomes and Risk Factors for Complications of Endoscopic Papillectomy: A Retrospective Analysis of a Single-Center Study. Ther Clin Risk Manag. 2021 May 28;17:531-541. doi: 10.2147/TCRM.S309103. eCollection 2021.
PubMed 34093018Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Choi SJ, Lee HS, Kim J, Choe JW, Lee JM, Hyun JJ, Yoon JH, Kim HJ, Kim JS, Choi HS. Clinical outcomes of endoscopic papillectomy of ampullary adenoma: A multi-center study. World J Gastroenterol. 2022 May 7;28(17):1845-1859. doi: 10.3748/wjg.v28.i17.1845.
PubMed 35633905Alali A, Espino A, Moris M, Martel M, Schwartz I, Cirocco M, Streutker C, Mosko J, Kortan P, Barkun A, May GR. Endoscopic Resection of Ampullary Tumours: Long-term Outcomes and Adverse Events. J Can Assoc Gastroenterol. 2020 Feb;3(1):17-25. doi: 10.1093/jcag/gwz007. Epub 2019 Mar 18.
PubMed 32010876
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
- ClinicalTrials.gov ID
- NCT06648746
- Acronym / sponsor ID
- 112233
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Oct 2024 (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.
Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.
Nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.
Detailed description
The relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure.
The occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. Thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ampullectomy | – | –Consecutive adult patients submitted to endoscopic resection of an ampullary adenoma in each of the participating center for which endoscopic ampullectomy was performed from 1st January 2019 to 31th December will be included. Clinical and demographic data related to the patient, and data pertaining to the ampullary lesion and the endoscopic ampullectomy procedure will be obtained by reviewing the medical records of each participating center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients submihed to endoscopic resection of an ampullary adenoma in each of the participating center (ULS de Santo António - Porto; ULS São João - Porto)
Key inclusion criteria (6 listed)
- Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:
- A minimum follow-up period of one year afer endoscopic ampullary resection.
Key exclusion criteria (7 listed)
- Patients with lesions with the following features were excluded:
- Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
- Patients with a follow-up of less than a year after endoscopic ampullary resection
- Patients with pancreas divisum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Therapeutic success
Time frame: 1 year
- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
Safety outcomes
Time frame: 1 year
- Rate of adverse events related to endoscopic resection of ampullary adenomas
2 secondary outcomes
Prophylaxis
Time frame: 1 year
Risk factors
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 37656482Walter D, Schnitzbauer AA, Schulze F, Trojan J. The Diagnosis and Treatment of Ampullary Carcinoma. Dtsch Arztebl Int. 2023 Oct 27;120(43):729-735. doi: 10.3238/arztebl.m2023.0195.
- 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 38826909Shahzad MI, Pickering G, Zafar M, Hayat S, Vlavianos P. The Duodenal Accessory Ampulloma and the Role of Endoscopic Retrograde Cholangiopancreatography (ERCP) in Familial Adenomatous Polyposis Coli Inheritance. Cureus. 2024 May 1;16(5):e59445. doi: 10.7759/cureus.59445. eCollection 2024 May.
- Background: PubMed 34590592Rizzo A, Dadduzio V, Lombardi L, Ricci AD, Gadaleta-Caldarola G. Ampullary Carcinoma: An Overview of a Rare Entity and Discussion of Current and Future Therapeutic Challenges. Curr Oncol. 2021 Sep 1;28(5):3393-3402. doi: 10.3390/curroncol28050293.
- Background: PubMed 32030370Poley JW, Campos S. Methods and outcome of the endoscopic treatment of ampullary tumors. Ther Adv Gastrointest Endosc. 2020 Jan 21;13:2631774519899786. doi: 10.1177/2631774519899786. eCollection 2020 Jan-Dec.
- Background: PubMed 22064552Patel R, Varadarajulu S, Wilcox CM. Endoscopic ampullectomy: techniques and outcomes. J Clin Gastroenterol. 2012 Jan;46(1):8-15. doi: 10.1097/MCG.0b013e318233a844.
- Background: PubMed 37835881Maselli R, de Sire R, Fugazza A, Spadaccini M, Colombo M, Capogreco A, Beyna T, Repici A. Updates on the Management of Ampullary Neoplastic Lesions. Diagnostics (Basel). 2023 Oct 6;13(19):3138. doi: 10.3390/diagnostics13193138.
- Background: PubMed 25818543Lai JH, Shyr YM, Wang SE. Ampullectomy versus pancreaticoduodenectomy for ampullary tumors. J Chin Med Assoc. 2015 Jun;78(6):339-44. doi: 10.1016/j.jcma.2015.02.002. Epub 2015 Mar 26.
- Background: PubMed 32740000Klair JS, Irani S, Kozarek R. Best techniques for endoscopic ampullectomy. Curr Opin Gastroenterol. 2020 Sep;36(5):385-392. doi: 10.1097/MOG.0000000000000657.
- Background: PubMed 28990001Kim AL, Choi YI. Safety of duodenal ampullectomy for benign periampullary tumors. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):146-150. doi: 10.14701/ahbps.2017.21.3.146. Epub 2017 Aug 31.
- Background: PubMed 33485767Jung YK, Paik SS, Choi D, Lee KG. Transduodenal ampullectomy for ampullary tumor. Asian J Surg. 2021 May;44(5):723-729. doi: 10.1016/j.asjsur.2020.12.021. Epub 2021 Jan 21.
- Background: PubMed 34093018Jiang L, Chai N, Li M, Linghu E. Therapeutic Outcomes and Risk Factors for Complications of Endoscopic Papillectomy: A Retrospective Analysis of a Single-Center Study. Ther Clin Risk Manag. 2021 May 28;17:531-541. doi: 10.2147/TCRM.S309103. eCollection 2021.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
Paulo Salgueiro, MD, PhD principal investigator
Universidade do Porto
Questions about this trial
What is this clinical trial studying?
An observational study of Ampulla of Vater Adenoma and Ampulla of Vater Disease (Benign/Malignancy), run by Universidade do Porto.
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 6 inclusion and 7 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Paulo Salgueiro, MD, PhD (00351222077500, paulosalgueiro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic success (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06648746, which also lists 15 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 18 Oct 2024.