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

NCT07781137 | Recruiting

• 1 other identifier: 2025/PID00692 2025/ETH00587
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla.
2. 2.To assess the safety profile of the procedure.
3. 3.To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
4. 4.Diagnostic yield of endoscopic surveillance post endoscopic resection
5. 5.Requirements for surgery

Conditions

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

Outcome Measures

Primary Outcomes (3)

• To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla

  From enrolment to final surveillance endoscopy (generally 5 years after index procedure)

• To assess duodenal and ampulla endoscopic resection procedure adverse event rates

  From enrolment to final surveillance endoscopy (generally 5 years after index procedure)

• To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.

  From enrolment to final surveillance endoscopy (generally 5 years after index procedure)

Secondary Outcomes (1)

• Requirements for surgery

  From enrolment to final surveillance endoscopy (generally 5 years after index procedure)

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

This study will be conducted at a tertiary referral centre specialising in endoscopic therapy in the duodenum and ampulla. Identifying patients: Participants will be sourced through the current electronic documentation system, utilising the following methods: Provation (endoscopic reporting software) key search for key terms related to: * Duodenal polyp(s) * Duodenal lesion * Duodenal SEL * Duodenal submucosal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy Electronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing: * Duodenal polyp(s) * Duodenal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy

You may qualify if:

• 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

You may not qualify if:

• Age less than 18

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Endoscopy, Westmead hospital, Western Sydney Local Health District

Sydney, New South Wales, Australia

RECRUITING

MeSH Terms

Conditions

Duodenal Neoplasms; Adenoma; Adenocarcinoma, Papillary

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma

Central Study Contacts

Clarence Kerrison, MBChB, MBiomedSc, FRACP

CONTACT

+61413361347; clarence.kerrison@health.nsw.gov.au

Study Design

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

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: August 24, 2026
• Study Start: May 23, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AU (1)