NCT02200250

Brief Summary

Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
7.2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

July 17, 2014

Last Update Submit

June 28, 2023

Conditions

Barretts Esophagus

Outcome Measures

Primary Outcomes (1)

  • Reviewing patients symptoms following resection

    Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.

    up to 3 years

Study Arms (1)

Post Barretts Excision

Patients who have undergone an EMR for Barretts Oesophagus

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have or have had Barrett's Oesophagus with high grade dysplasia or adenocarcinoma.

You may qualify if:

  • years or over
  • Have or have had Barrett's Oesophagus

You may not qualify if:

  • Do not have Barrett's Oesophagus
  • Have not had Barrett's Oesophagus resected at Westmead Hospital

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

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michael J Bourke, MBBS

    Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR
0

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 17, 2014

First Posted

July 25, 2014

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

AU(1)