ClinicalTrials.gov
ClinicalTrials.gov Menu

Upper GI Outcomes Following EMR (UGI-EMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02305290
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Brief Summary:
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)

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

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 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 Upper Gastrointestinal Lesions will be included in this cohort.
Procedure: Endoscopic Mucosal Resection



Primary Outcome Measures :
  1. Observed procedural data [ Time Frame: 14 days ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes


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 UGIT lesions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

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): NCT02305290


Contacts
Contact: Rebecca Sonson, BN 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au

Locations
Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Principal Investigator: Michael J Bourke, MBBS         
Sub-Investigator: Stephen J Williams, MBBS         
Sub-Investigator: Farzan F Bahin, MBBS         
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: NCT02305290     History of Changes
Other Study ID Numbers: HREC2014/7/4.6 (4031)
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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