Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01618643
Status:
UNKNOWN
Last Update Posted:
2012-06-14
First Post:
2012-06-11
Brief Title:
Aceto-whitening in the Assessment of Gastrointestinal Neoplasia
Sponsor:
Portsmouth Hospitals NHS Trust
Organization:
Portsmouth Hospitals NHS Trust
Study Overview
Official Title:
Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barretts Oesophagus
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Barretts 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 Barretts oesophagus and colon This reaction will be much shorter in areas with abnormal pathology like dysplasia or cancer
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 Barretts 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 Barretts oesophagus and colon This reaction will be much shorter in areas with abnormal pathology like dysplasia or cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None