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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic success | - Rate of adenoma recurrence after endoscopic resection of ampullary adenomas | 1 year |
| Safety outcomes | - Rate of adverse events related to endoscopic resection of ampullary adenomas | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prophylaxis | - Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis | 1 year |
| Risk factors | To perform a multivariate analysis of patient, lesion and procedure characteristics that correlate with the incidence of adverse events |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulo Salgueiro, MD, PhD | Contact | 00351222077500 | paulosalgueiro@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Salgueiro, MD, PhD | Universidade do Porto | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37656482 | Background | 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. | |
| 33728632 | Background | 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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 year |
| 38826909 | Background | Shahzad 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. |
| 34590592 | Background | Rizzo 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. |
| 32030370 | Background | Poley 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. |
| 22064552 | Background | Patel R, Varadarajulu S, Wilcox CM. Endoscopic ampullectomy: techniques and outcomes. J Clin Gastroenterol. 2012 Jan;46(1):8-15. doi: 10.1097/MCG.0b013e318233a844. |
| 37835881 | Background | Maselli 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. |
| 25818543 | Background | Lai 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. |
| 32740000 | Background | Klair JS, Irani S, Kozarek R. Best techniques for endoscopic ampullectomy. Curr Opin Gastroenterol. 2020 Sep;36(5):385-392. doi: 10.1097/MOG.0000000000000657. |
| 28990001 | Background | Kim 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. |
| 33485767 | Background | Jung 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. |
| 34093018 | Background | Jiang 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. |
| 31863440 | Background | Dumonceau 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. |
| 35633905 | Background | Choi 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. |
| 32010876 | Background | Alali 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. |