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Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach (OERS)

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ClinicalTrials.gov Identifier: NCT02306707
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Brief Summary:
A patient referred to have a lesion in the stomach removed. The aims of this study are to collect information on the technique of endoscopic removal of such lesions. By collecting information on a large number of patients undergoing this procedure the investigators can determine the best ways of diagnosing and removing these lesions safely and effectively.

Condition or disease Intervention/treatment
Adenoma, Villous Procedure: Endoscopic Mucosal Resection

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Endoscopic Mucosal Resection
Patients who are referred for Endoscopic Mucosal Resection of Stomach Lesions will be included in this cohort.
Procedure: Endoscopic Mucosal Resection



Primary Outcome Measures :
  1. 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 ]
    Perform cost-utility analyses comparing different treatment approaches for stomach lesions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have stomach adenomas which are amendable to Endoscopic Mucosal Resection
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lesion less than 10mm
  • Stomach lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
  • Aged younger than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306707


Contacts
Contact: Rebecca Sonson, BN 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au
Contact: Farzan F Bahin, MBBS 98455555 ext 56700 farzan.fahrtash@sydney.edu.au

Locations
Australia, New South Wales
Westmead Hospital Endoscopy Unit Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Contact: Michael J Bourke, BN    98455555 ext 56700    bec2153@gmail.com   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02306707     History of Changes
Other Study ID Numbers: HREC2014/5/4.1 (3970)
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Adenoma
Adenoma, Villous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms