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Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions

NCT07781137 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-08-24

No results posted yet for this study

Summary

Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region.

Primary Objective

1. To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla.
2. To assess the safety profile of the procedure.
3. To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.

Secondary Objectives

1. Diagnostic yield of endoscopic surveillance post endoscopic resection
2. Requirements for surgery

Conditions

  • Duodenal Adenoma
  • Duodenal Carcinoma
  • Papillary Adenoma
  • Papillary Adenocarcinoma
  • Endoscopic Mucosal Resection

Sponsors & Collaborators

  • Western Sydney Local Health District

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-23
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781137 on ClinicalTrials.gov