NCT02305290

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

8.6 years

First QC Date

July 30, 2014

Last Update Submit

March 25, 2025

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 Upper Gastrointestinal Lesions will be included in this cohort.

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal ResectionPROCEDURE
Endoscopic Mucosal Resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have Upper Gastrointestinal Tract adenomas which are amendable to Endoscopic Mucosal Resection

You may qualify if:

  • UGIT 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
  • Gastric lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
  • Aged younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Adenoma, Villous

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Michael J Bourke, MBBS

    Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2014

First Posted

December 2, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2023

Study Completion

September 1, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)