Clinical trial · Observational
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
NCT02306603CI-TRIAL-00087754OERDArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma, Villous | Villous Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Mucosal Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Endoscopic Mucosal Resection
- description
- Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.
- interventionNames
- Procedure: Endoscopic Mucosal Resection
Primary outcomes (1)
- measure
- Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
- timeFrame
- 14 days
Secondary outcomes (1)
- measure
- Analysis of the costs of this procedure compared to previous treatments
- timeFrame
- 14 days
- description
- Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDGupta 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
- DERIVEDWang 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
- DERIVEDSidhu 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
- DERIVEDKlein 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