Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

NCT02306603 | Recruiting DMC

• 1 other identifier: HREC 2014/5/4.3 (3972)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Adenoma, Villous

Outcome Measures

Primary Outcomes (1)

• Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

  14 days

Secondary Outcomes (1)

• Analysis of the costs of this procedure compared to previous treatments

  14 days

Study Arms (1)

Endoscopic Mucosal Resection

Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal Resection PROCEDURE

Endoscopic Mucosal Resection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection

You may qualify if:

• \* Duodenal and ampullary lesion \> 10mm
• Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
• Aged 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital Endoscopy Unit

Sydney, New South Wales, 2145, Australia

RECRUITING

Related Publications (4)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Adenoma, Villous

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael J Bourke, MBBS

  Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bourke, MBBS

CONTACT

88905555; michael@citywestgastro.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2014
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)