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Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barrett's Oesophagus


N/A
18 Years
N/A
Open (Enrolling)
Both
Barrett Esophagus, Barrett Metaplasia, Barrett Oesophagitis With Dysplasia, Barrett Adenocarcinoma

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Trial Information

Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barrett's Oesophagus


This is a prospective pilot study. It is standard practice within our unit to use acetic
acid for the detection of neoplasia. No patient would receive any additional intervention
that would not normally be performed.

We will record the surface and vascular patterns before and after acetic acid spray. As
usual we will then apply acetic acid spray to the Barrett's epithelium and time how long it
takes for the aceto whitening to disappear. It is the timing of the disappearance that is
the key study intervention. We will biopsy these areas to confirm the diagnosis. Again this
is standard practice and no patient will be denied an intervention that is normally
performed, and no extra interventions will be performed over and above the standard clinical
practice.

We will correlate the histology to the aceto-whitening disappearance time to identify a
threshold time which can serve as a cut off between neoplastic and non-neoplastic tissue.

We hypothesise that the aceto-whitening reaction lasts much longer in the normal epithelium
of Barrett's oesophagus and colon. This reaction will be much shorter in areas with abnormal
pathology like dysplasia or cancer.


Inclusion Criteria:



- Patients with known Barrett's metaplasia under surveillance

- Patients with Barrett's metaplasia who had undergone endoscopic treatment for
neoplasia previously and were under surveillance for metachronous neoplasia

- Patients suspected of neoplasia referred for endoscopic mucosal resection or other
targeted endoscopic treatment of the lesion

Exclusion Criteria:

- Oesophagitis

- Contact bleeding

- Acute mucosal trauma

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Timing of disappearance of aceto-whitening for Barrett's metaplasia, HGD and cancer

Outcome Description:

To quantify the differential in the timing of the disappearance of the aceto-whitening reaction between metaplastic tissue, dysplastic tissue and invasive cancer after acetic acid dye spray in the oesophagus and colon.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Pradeep Bhandari, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Portsmouth Hospitals NHS Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

PHT/2010/25

NCT ID:

NCT01618643

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Barrett Esophagus
  • Barrett Metaplasia
  • Barrett Oesophagitis With Dysplasia
  • Barrett Adenocarcinoma
  • Barrett's
  • High grade dysplasia
  • HGD
  • IMC
  • Intramucosal cancer
  • Acetic acid
  • Chromoendoscopy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Neoplasms
  • Esophagitis
  • Metaplasia

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