Aceto-whitening in the Assessment of Gastrointestinal Neoplasia

NCT01618643 | Completed DMC

• 1 other identifier: PHT/2010/25
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Barrett Esophagus; Barrett Metaplasia; Barrett Oesophagitis With Dysplasia; Barrett Adenocarcinoma

Keywords

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

Outcome Measures

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.

  18 months

Secondary Outcomes (1)

• To differentiate mucosal neoplasia from invasive cancer

  24 months

Study Arms (1)

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

Acetic acid chromoendoscopy PROCEDURE

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.

Acetic acid chromoendoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surveillance for Barrett's oesophagus

You may qualify if:

• 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

You may not qualify if:

• Oesophagitis
• Contact bleeding
• Acute mucosal trauma

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• University of Portsmouth: collaborator

Study Sites (1)

Portsmouth Hospitals NHS trust

Portsmouth, Hampshire, PO76TS, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

Only pathology retained is for NHS purposes only. No separate tissue retained for the study

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Pradeep Bhandari, MD, FRCP

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: November 23, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

GB (1)