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Comparing a targeted biopsy regimen with a targeted and surveillance (Seattle protocol) biopsy regimen in eradicated dysplastic Barrett's oesophagus: a prospective study

Comparing a targeted biopsy regimen with a combined targeted and surveillance (Seattle protocol) biopsy regimen in endoscopically eradicated Barrett’s dysplasia/intramucosal adenocarcinoma: a prospective study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001198213
Enrollment
121
Registered
2018-07-18
Start date
2018-08-01
Completion date
2020-12-31
Last updated
2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is examining two biopsy regimens for surveillance follow-up in patients where Barrett’s oesophagus with dysplasia or cancer has been eradicated. Who is it for? You may be eligible for this study if you have undergone successful endoscopic Barrett's oesophagus and/or oesophageal adenocarcinoma eradication and are currently having follow-up surveillance endoscopies. Study details All participants will undergo surveillance endoscope and biopsy as per their current standard treatment. The study personnel will record the time taken to take samples and perform economic analysis. Please note there is no additional testing or input required by participants in this study beyond participating in their routine care. It is hoped this research will demonstrate that a reduced test biopsy regimen is more cost- and time-efficient than the standard biopsy regimen without reducing the surveillance quality.

Interventions

We will be comparing two groups of outcomes in the same patient (ie. they become their own control group) - we will be practicing standard care with regards to endoscopic follow up of eradicated dysplastic Barrett's oesophagus and intramucosal oesophageal adenocarcima. This involves taking targeted biopsies of endoscopically abnormal areas (eg. nodules or ulcers) as well as biopsies from the gastric cardia and along the affected portion of the oesophagus in a systematic manner; four quadrant bio

We will be comparing two groups of outcomes in the same patient (ie. they become their own control group) - we will be practicing standard care with regards to endoscopic follow up of eradicated dysplastic Barrett's oesophagus and intramucosal oesophageal adenocarcima. This involves taking targeted biopsies of endoscopically abnormal areas (eg. nodules or ulcers) as well as biopsies from the gastric cardia and along the affected portion of the oesophagus in a systematic manner; four quadrant biopsies every 1cm will be taken as per the Seattle protocol, which is current standard of care. We will be recording the time and resources required for surveillance biopsies as well as the results of these to determine whether omitting these surveillance biopsies as per Seattle protocol in the future would be non-inferior to current standard of practice with regards to histology results and patient outcome; this would significantly save on time and costs associated with the process. Therefore, the two groups will be as follows: Control - gastric cardia, targeted and surveillance biopsies Test - gastric cardia and surveillance biopsies only

Sponsors

Princess Alexandra Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients who have undergone successful Barrett's oesophagus eradication who are currently having follow-up surveillance endoscopies

Exclusion criteria

patients with dysplastic Barrett's that have not achieved complete eradication of intestinal metaplasia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026