Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

Colonic Polyp Clinical Trial

— Acetic  

Official title:

Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157803
• Other study ID #: HAleman
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: November 2019
• Source: Hospital Aleman
• Contact: Federico E Bentolila, MD
• Phone: 54 11 48277000
• Email: fbentolila[@]hospitalaleman.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of acetic acid in the characterization of polyps, produces a homogeneous white staining in sessile serrated adenomas, but not in tubular or tubulo-villous adenomas, a simple approach to predict polyp histopathology.

To determine the diagnostic accuracy of the use of acetic acid on tubular and serrated adenomas, during colonoscopy, a prospective diagnostic accuracy study was designed, taking as gold standard the pathological anatomy of the resected polyps.

Polyps found during a colonoscopy with suspicion of sessile serrated adenomas or tubular/tubulo villous will be included.

Description:

In our experience tubular or tubulovillous adenomas with acetic acid have the same behavior as normal colonic mucosa. When sprayed with acetic acid they stain white, as well as the surrounding mucosa, but with a subsequent rapid loss of the effect. In contrast, serrated adenomas maintain an "aceto-whitening" reaction even though the surrounding normal mucosa loses staining.

The objectives are to determine the sensitivity and specificity, positive and negative probability coefficients of the positive or negative aceto-whitening reaction on serrated adenomas and tubular-tubulo-villous adenomas.

To determine the diagnostic accuracy of the use of acetic acid on tubular, tubulo-villous and serrated adenomas a prospective diagnostic accuracy study was designed considering the gold standard as the pathological anatomy of resected polyps.

As independent variables the presence or absence of aceto-whitening reaction after staining and the diagnostic impression of the endoscopist without acetic acid are considered. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.

In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.

Place: German Hospital, endoscopy unit.

Data analysis: the data collected in double-entry tables will be captured to obtain the same sensitivity, specificity and positive or negative probability coefficients.

Sample size: 100 polyps.

Estimated duration: 1 month

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with colonic polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.

Exclusion Criteria:

• Known acetic acid allergy

• Known or documented history of adenomatous or serrated polyposis

• Patients with inflammatory bowel disease

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Diagnostic Test:
• Acetic acid % spray
If during a videcolonoscopy a polyp is found with suspicion of tubular, tubulovillious or Serrated adenoma, the endoscopist will proceed to stain it using diffuser and acetic acid at a concentration of 3%. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa. In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.

Locations

Country	Name	City	State
Argentina	Hospital Aleman	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Aleman

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Popoutchi P, Mota FL, Averbach M, de Menezes MS, Coudry RA. Acetic acid spray contribution in the endoscopic diagnosis of serrated polyposis syndrome. VideoGIE. 2018 Jan 5;3(2):65-67. doi: 10.1016/j.vgie.2017.11.011. eCollection 2018 Feb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction	The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa. In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly. This outcome will be evaluated visually by the involved endoscopist.	1 month
Primary	Histopathology of resected polyps	Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.	1 month
Secondary	Histopathology impression of the endoscopist without acetic acid after resection.	Diagnostic guess of the endoscopist without acetic acid taking into account the shape of the polyp defined in the Paris classification and Kudo's pitt pattern	1 month