An observational study in Duodenal Adenoma, Duodenal Carcinoma and Papillary Adenoma, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Western Sydney Local Health District · Observational
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
Secondary Objectives
51 studies on the registry are indexed under Duodenal Neoplasms; 14 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 17 observational studies indexed under Duodenal Neoplasms.
Browse Duodenal Neoplasms studies →Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.
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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:
Electronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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)
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)
Requirements for surgery
Rate of surgery
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Plan to share: Yes — Study protocol and Data dictionary
Supporting information: Study protocol
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jan 2030, 56 months after the start.
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Western Sydney Local Health District