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NCT Number: NCT07781137

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Endoscopy, Westmead hospital, Western Sydney Local Health District

Sydney, New South Wales, Australia

Location status: Recruiting

Location contact

Clarence Kerrison, MBChB, MBiomedSc, FRACP

CONTACT

[email protected]

+61413361347

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

  2. To assess duodenal and ampulla endoscopic resection procedure adverse event rates

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

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

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

Secondary outcomes

  1. Requirements for surgery

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

    Rate of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Clarence Kerrison, MBChB, MBiomedSc, FRACP

CONTACT

[email protected]

+61413361347

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

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

Acronym: DuoP-ER

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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