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CompletedNCT01618643Updated Dec 24, 2025

Aceto-whitening in the Assessment of Gastrointestinal Neoplasia

An observational study in Barrett Esophagus, Barrett Metaplasia and Barrett Oesophagitis With Dysplasia, sponsored by Portsmouth Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Portsmouth Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
197
Ages
18 Years and older
Sex
All
01

Study summary

Acetic acid chromoendoscopy is an established standard technique used to detect dysplasia within the gastrointestinal tract. Acetic acid spray helps to identify neoplasia by highlighting the surface pattern, highlighting the vascular pattern and by a process known as the aceto-whitening reaction, where tissues take acetic acid and turn white for a brief period and then slowly revert back to a normal colour. The neoplastic surface and vascular pattern are all very well described, and have played a big role in the recognition of early cancer. The aceto-whitening reaction is well described but the differential in timing between neoplastic and non-neoplastic areas is not well understood.

The investigators aim to establish the differential in the timing of the disappearance of the aceto-whitening reaction between healthy tissue, dysplastic tissue, intramucosal cancer and invasive cancer after acetic acid dye spray in the oesophagus and colon. By understanding this better, the investigators may be able to predict with greater accuracy whether a highlighted abnormal area is cancer or high grade dysplasia, or whether it is low grade dysplasia or inflammation, which has significant prognostic implications for the patient.

The investigators hypothesize that the differential in the timing of the disappearance of the aceto-whitening reaction between normal and abnormal tissue could help in the detection of gastrointestinal neoplasia.

Read the detailed description

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.

02

Conditions studied

  • Barrett Esophagus
  • Barrett Metaplasia
  • Barrett Oesophagitis With Dysplasia
  • Barrett Adenocarcinoma

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Keywords

  • Barrett's
  • High grade dysplasia
  • HGD
  • IMC
  • Intramucosal cancer
  • Acetic acid
  • Chromoendoscopy
03

In context

Barrett Esophagus

310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.

This study's enrollment of 197 is above the median of 127 across 115 observational studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing surveillance for Barrett's oesophagus

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

Exclusion Criteria:

  • Oesophagitis
  • Contact bleeding
  • Acute mucosal trauma
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
197 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Acetic acid chromoendoscopy

    * 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

    Procedure: Acetic acid chromoendoscopy

Interventions

  • ProcedureAcetic acid chromoendoscopy

    Prospective observational pilot study. We would examine patients with Barrett's epithelium that is either healthy or has suspected areas of neoplasia. We will apply acetic acid spray to areas of healthy Barrett's metaplasia and time how long it takes for the aceto whitening to disappear. We will repeat this in cases referred with SM invasive cancer, intramucosal cancer, suspected high grade dysplasia and possible low grade dysplasia. We will record how long it takes for the acetowhitening to disappear. We will biopsy these areas to confirm the diagnosis. We will correlate the histology to the aceto-whitening time to see if there is a correlation between the degree of neoplasia and the aceto-whitening time after acetic acid dye spray.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 18 months

Secondary outcomes

  1. To differentiate mucosal neoplasia from invasive cancer

    To differentiate high grade displasia and intramucosal cancer from invasive cancer using the aceto-whitening timing

    Time frame: 24 months

07

Study locations

1 site
  • Portsmouth Hospitals NHS trust
    Portsmouth, Hampshire PO76TS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01618643
Lead sponsor
Portsmouth Hospitals NHS Trust
Collaborators
University of Portsmouth
Responsible party
Sponsor
First posted
Jun 13, 2012
Start date
Nov 23, 2010
Primary completion
Sep 2011
Completion
Sep 2012
Last update
Dec 24, 2025

Study contacts

Pradeep Bhandari, MD, FRCP
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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