- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618643
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hampshire
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Portsmouth, Hampshire, United Kingdom, PO76TS
- Portsmouth Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timing of disappearance of aceto-whitening for Barrett's metaplasia, HGD and cancer
Time Frame: 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To differentiate mucosal neoplasia from invasive cancer
Time Frame: 24 months
|
To differentiate high grade displasia and intramucosal cancer from invasive cancer using the aceto-whitening timing
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pradeep Bhandari, MD, FRCP, Portsmouth Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Esophageal Diseases
- Precancerous Conditions
- Barrett Esophagus
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Anticarcinogenic Agents
- Acetic Acid
- Retinol acetate
Other Study ID Numbers
- PHT/2010/25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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