- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305290
Upper GI Outcomes Following EMR (UGI-EMR)
June 28, 2023 updated by: Professor Michael Bourke
Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER) of superficial lesions of the Upper Gastrointestinal Tract(UGIT)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Endoscopic resection (ER) of superficial lesions of the upper gastrointestinal tract 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 UGIT.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca Sonson, BN
- Phone Number: 59779 98455555
- Email: Kathleen.goodrick@health.nsw.gov.au
Study Locations
-
-
New South Wales
-
Westmead, New South Wales, Australia, 2145
- Recruiting
- Westmead Endoscopy Unit
-
Principal Investigator:
- Michael J Bourke, MBBS
-
Sub-Investigator:
- Farzan F Bahin, MBBS
-
Contact:
- Rebecca Sonson, BN
- Phone Number: 59779 98455555
- Email: Kathleen.goodrick@health.nsw.gov.au
-
Sub-Investigator:
- Stephen J Williams, MBBS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who have Upper Gastrointestinal Tract adenomas which are amendable to Endoscopic Mucosal Resection
Description
Inclusion Criteria:
- UGIT lesion > 10mm
- Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
- Aged 18 years or older
Exclusion Criteria:
- Lesion less than 10mm
- Gastric lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
- Aged younger than 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Endoscopic Mucosal Resection
Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions will be included in this cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed procedural data
Time Frame: 14 days
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of the costs of this procedure compared to previous treatments
Time Frame: 14 days
|
Perform cost-utility analyses comparing different treatment approaches for UGIT lesions
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 30, 2014
First Submitted That Met QC Criteria
November 26, 2014
First Posted (Estimated)
December 2, 2014
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC2014/7/4.6 (4033)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenoma, Villous
-
Martin-Luther-Universität Halle-WittenbergUniversity of Ulm; Deutsche Krebshilfe e.V., Bonn (Germany); KKS NetzwerkCompletedColorectal Serrated Adenomas | Colorectal Tubular Adenomas | Colorectal Villous Adenomas | Colorectal Tubulovillous AdenomasGermany
-
Professor Michael BourkeRecruitingAdenoma, VillousAustralia
-
Professor Michael BourkeRecruitingAdenoma, VillousAustralia
-
London North West Healthcare NHS TrustCompletedAdenoma Colon | Serrated AdenomaUnited Kingdom
-
Mansoura UniversityWithdrawn
-
Fondazione Poliambulanza Istituto OspedalieroCompletedAdenoma Colon | Colonic AdenomaItaly
-
National Cancer Institute (NCI)Active, not recruitingColorectal Adenoma | Colorectal Adenoma With Severe Dysplasia | Colorectal Tubulovillous AdenomaUnited States, Puerto Rico
-
Alexandra Hospital, Athens, GreeceCompletedColonoscopy | Adenoma Detection Rate | Adenoma Miss Rate | RetroflexionGreece
-
Hospital Sirio-LibanesCompletedColorectal Cancer | Colonoscopy | Adenoma Detection Rate | Adenoma Colon | Colorectal Polyp | Sessile Serrated Adenoma | Quality IndicatorBrazil
-
Azienda Unità Sanitaria Locale della RomagnaRecruitingAmpulla of Vater Adenoma | Ampullary Cancer | Ampulla of Vater Cancer | Ampullary AdenomaItaly
Clinical Trials on Endoscopic Mucosal Resection
-
Instituto do Cancer do Estado de São PauloUniversity of Sao PauloCompletedColorectal Neoplasms | AdenomaBrazil
-
Professor Michael BourkeRecruitingAdenoma, VillousAustralia
-
Professor Michael BourkeRecruitingAdenoma, VillousAustralia
-
Medical University of ViennaCompletedBarrett's Mucosa With High Grade Intraepithelial Neoplasia (HGIEN)Austria
-
Professor Michael BourkeCompletedColonic PolypsAustralia
-
University of British ColumbiaRecruitingColon Adenoma | Colon Polyp | Colon LesionCanada
-
Massachusetts General HospitalCompletedConstipation | Hirschsprung DiseaseUnited States
-
Massachusetts General HospitalUnknownChronic Constipation | Hirschsprung's DiseaseUnited States
-
Chonnam National University HospitalWithdrawnColonic PolypsKorea, Republic of
-
UMC UtrechtComprehensive Cancer Centre The NetherlandsUnknownColorectal NeoplasmsNetherlands