Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps

Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

Sponsors

Lead sponsor: Hospital Aleman

Source Hospital Aleman
Brief 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.

Detailed 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

Overall Status Recruiting
Start Date October 25, 2019
Completion Date November 15, 2019
Primary Completion Date November 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction 1 month
Histopathology of resected polyps 1 month
Secondary Outcome
Measure Time Frame
Histopathology impression of the endoscopist without acetic acid after resection. 1 month
Enrollment 100
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Acetic acid % spray

Description: 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.

Arm group label: Patient cohort

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Daniel Cimmino, MD Principal Investigator ENDIBA SAGE
Overall Contact

Last name: Federico E Bentolila, MD

Phone: 54 11 48277000

Phone ext: 2861

Email: [email protected]

Location
facility status contact Hospital Aleman Christian Ahumada, MD 54 11 4827 7000 2861 [email protected]
Location Countries

Argentina

Verification Date

November 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hospital Aleman

Investigator full name: Federico Bentolila

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Patient cohort

Arm group type: Other

Description: Patients with polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videcolonoscopy.

Acronym Acetic
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov