Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

NCT06648746 | Not Yet Recruiting

• 1 other identifier: 112233
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Ampulla of Vater Adenoma; Ampulla of Vater Disease (Benign/Malignancy)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Prophylaxis

  1 year

• Risk factors

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Related Publications (15)

• 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 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.

  PMID: 33728632 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.

  PMID: 38826909 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.

  PMID: 34590592 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.

  PMID: 32030370 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.

  PMID: 22064552 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.

  PMID: 37835881 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.

  PMID: 25818543 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.

  PMID: 32740000 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.

  PMID: 28990001 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.

  PMID: 33485767 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.

  PMID: 34093018 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.

  PMID: 31863440 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.

  PMID: 35633905 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.

  PMID: 32010876 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paulo Salgueiro, MD, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Salgueiro, MD, PhD

CONTACT

00351222077500; paulosalgueiro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 18, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10