Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Mucosal Resection.
- Who it may be relevant to
- Registry conditions: Adenoma, Villous. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Overview
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.
Detailed description
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.
Interventions
- Procedure Endoscopic Mucosal Resection
Primary outcome measures
- Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes [Time frame: 14 days]
Secondary outcome measures (1)
- Analysis of the costs of this procedure compared to previous treatments [Time frame: 14 days]
Eligibility criteria
Inclusion criteria
\* Duodenal and ampullary lesion > 10mm
- Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
- Aged 18 years or older
Exclusion criteria
- Lesion less than 10mm
- Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
- Aged younger than 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Westmead Hospital Endoscopy Unit — Sydney
Publications
- Gupta S, Craciun A, Wang H, Whitfield A, Gauci J, O'Sullivan T, Cronin O, Abu Arisha M, Klein A, Lee EYT, Burgess NG, Bourke MJ. Hybrid resection versus conventional resection for laterally spreading lesions of the papilla. Gastrointest Endosc. 2024 Mar;99(3):428-436. doi: 10.1016/j.gie.2023.10.034. Epub 2023 Oct 17. PMID 37858758
- Wang H, Sidhu M, Gupta S, Cronin O, O'Sullivan T, Whitfield A, Burgess NG, Bourke MJ. Cold snare EMR for the removal of large duodenal adenomas. Gastrointest Endosc. 2023 Jun;97(6):1100-1108. doi: 10.1016/j.gie.2023.01.040. Epub 2023 Jan 28. PMID 36720290
- Sidhu M, Fritzsche JA, Klein A, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos). Gastrointest Endosc. 2021 Jun;93(6):1373-1380. doi: 10.1016/j.gie.2020.11.024. Epub 2020 Dec 4. PMID 33285144
- Klein A, Qi Z, Bahin FF, Awadie H, Nayyar D, Ma M, Voermans RP, Williams SJ, Lee E, Bourke MJ. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy. 2018 Oct;50(10):972-983. doi: 10.1055/a-0587-5228. Epub 2018 May 16. PMID 29768645
Identifiers
NCT: NCT02306603 · HREC 2014/5/4.3 (3972)