Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07781137
Acronym
DuoP-ER
Enrollment
1000
Registered
2026-08-24
Start date
2025-05-23
Completion date
2030-01-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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. 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

Interventions

None listed

Sponsors

Western Sydney Local Health District
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papillaFrom enrolment to final surveillance endoscopy (generally 5 years after index procedure)
To assess duodenal and ampulla endoscopic resection procedure adverse event ratesFrom 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

MeasureTime frameDescription
Requirements for surgeryFrom enrolment to final surveillance endoscopy (generally 5 years after index procedure)Rate of surgery

Countries

Australia

Contacts

CONTACTClarence Kerrison, MBChB, MBiomedSc, FRACP
clarence.kerrison@health.nsw.gov.au+61413361347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026