NCT01618643|CompletedDMC
Aceto-whitening in the Assessment of Gastrointestinal Neoplasia
Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barrett's Oesophagus
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Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barrett's Oesophagus
Sponsor study identifier
observational
197
1 country
1
Study Start
November 23, 2010
Actual (reported)Primary Completion
September 2011
Actual (reported)Study Completion
September 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2010
Actual (reported)September 2011
Actual (reported)June 11, 2012
Actual (reported)June 13, 2012
Actual (reported)September 2012
Actual (reported)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.
18 months
To differentiate mucosal neoplasia from invasive cancer
24 months
* 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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients undergoing surveillance for Barrett's oesophagus
Portsmouth Hospitals NHS trust
Portsmouth, Hampshire, PO76TS, United Kingdom
Only pathology retained is for NHS purposes only. No separate tissue retained for the study
Pradeep Bhandari, MD, FRCP
Portsmouth Hospitals NHS Trust
197 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2012
First Posted
June 13, 2012
Study Start
November 23, 2010
Actual (reported)Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barrett's Esophagus
Contact the study team to confirm eligibility.
Primary Completion
September 2011
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
December 24, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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