Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Therapeutic success [Срок оценки: 1 year]
• Safety outcomes [Срок оценки: 1 year]

Вторичные конечные точки (2)

• Prophylaxis [Срок оценки: 1 year]
• Risk factors [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 37656482
• 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 33728632
• 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. PMID 38826909
• 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. PMID 34590592
• 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. PMID 32030370
• 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. PMID 22064552
• 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. PMID 37835881
• 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. PMID 25818543

Идентификаторы

NCT: NCT06648746 · 112233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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