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
  Purpose

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.


Condition Intervention
Barrett Esophagus
Barrett Metaplasia
Barrett Oesophagitis With Dysplasia
Barrett Adenocarcinoma
Procedure: Acetic acid chromoendoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acetowhitening Time as a Novel Objective Tool for the Diagnosis of High Risk Neoplasia in Barrett's Oesophagus

Resource links provided by NLM:


Further study details as provided by Portsmouth Hospitals NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained

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


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing surveillance for Barrett's oesophagus

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618643

Locations
United Kingdom
Portsmouth Hospitals NHS trust Recruiting
Portsmouth, Hampshire, United Kingdom, PO76TS
Contact: Gaius Longcroft-Wheaton, MD, MRCP    +442392252913    gaius@gaius.wanadoo.co.uk   
Contact: Pradeep Bhandari, MD, FRCP    02392286000    deep3570@yahoo.co.uk   
Principal Investigator: Pradeep Bhandari, MD, FRCP         
Sub-Investigator: Gaius Longcroft-Wheaton, MD, MRCP         
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
University of Portsmouth
Investigators
Principal Investigator: Pradeep Bhandari, MD, FRCP Portsmouth Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Pradeep Bhandari, Consultant Gastroenterologist, Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01618643     History of Changes
Other Study ID Numbers: PHT/2010/25
Study First Received: June 11, 2012
Last Updated: June 13, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Portsmouth Hospitals NHS Trust:
Barrett's
High grade dysplasia
HGD
IMC
Intramucosal cancer
Acetic acid
Chromoendoscopy

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Esophagitis
Metaplasia
Carcinoma
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastroenteritis
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pathologic Processes
Retinol acetate
Adjuvants, Immunologic
Anticarcinogenic Agents
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014