Clinical trial · Observational
Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Duodenal Adenoma | Duodenal Non-Ampullary Adenoma | ALIAS | 0.90 |
| Duodenal Carcinoma | Duodenal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endoscopic Mucosal Resection | — | UNRESOLVED | — |
| Papillary Adenocarcinoma | Papillary Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Papillary Adenoma | Papillary Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla
- timeFrame
- From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
- measure
- To assess duodenal and ampulla endoscopic resection procedure adverse event rates
- timeFrame
- From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
- measure
- To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
- timeFrame
- From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Secondary outcomes (1)
- measure
- Requirements for surgery
- timeFrame
- From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than 18 * Mucosal or submucosal lesion in the duodenum or ampulla with endoscopic resection performed at Westmead hospital Endoscopic resection occurred between January 2010 to March 2025 Exclusion Criteria: * Age less than 18
References
Publications (0)
Data not yet available