Aceto-whitening in the Assessment of Gastrointestinal Neoplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Portsmouth Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Portsmouth
Information provided by (Responsible Party):
Pradeep Bhandari, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01618643
First received: June 11, 2012
Last updated: June 13, 2012
Last verified: June 2012

June 11, 2012
June 13, 2012
November 2010
September 2011   (final data collection date for primary outcome measure)
Timing of disappearance of aceto-whitening for Barrett's metaplasia, HGD and cancer [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01618643 on ClinicalTrials.gov Archive Site
To differentiate mucosal neoplasia from invasive cancer [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To differentiate high grade displasia and intramucosal cancer from invasive cancer using the aceto-whitening timing
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

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

Non-Probability Sample

Patients undergoing surveillance for Barrett's oesophagus

  • Barrett Esophagus
  • Barrett Metaplasia
  • Barrett Oesophagitis With Dysplasia
  • Barrett Adenocarcinoma
Procedure: Acetic 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.

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
Intervention: Procedure: Acetic acid chromoendoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
November 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United Kingdom
 
NCT01618643
PHT/2010/25
Yes
Pradeep Bhandari, Portsmouth Hospitals NHS Trust
Portsmouth Hospitals NHS Trust
University of Portsmouth
Principal Investigator: Pradeep Bhandari, MD, FRCP Portsmouth Hospitals NHS Trust
Portsmouth Hospitals NHS Trust
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP