Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Launched by UNIVERSIDADE DO PORTO · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the outcomes and potential complications of a procedure called endoscopic ampullectomy, which is used to remove benign tumors from the ampulla of Vater, a small area in the digestive system where bile and pancreatic juices enter the intestine. Although these tumors are rare, they can sometimes cause symptoms like jaundice (yellowing of the skin), pain, or pancreatitis (inflammation of the pancreas). The trial aims to better understand which patients are most likely to benefit from this procedure and what risks they might face, such as bleeding or pancreatitis.

To participate in the trial, individuals must be at least 18 years old and have a specific type of tumor that is small (up to 30 mm) and has no signs of cancer spreading. They should also be willing to have regular follow-up for at least a year after their procedure. While endoscopic ampullectomy has a high success rate, there is a possibility of complications, so it's important for potential participants to discuss this with their healthcare providers to see if this study is a good fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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.
• Exclusion Criteria:
• * 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.