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Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps (Acetic)

Primary Purpose

Colonic Polyp

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Acetic acid % spray
Sponsored by
Hospital Aleman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital AlemanRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Histopathology of resected polyps
Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2019
Last Updated
November 6, 2019
Sponsor
Hospital Aleman
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1. Study Identification

Unique Protocol Identification Number
NCT04157803
Brief Title
Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps
Acronym
Acetic
Official Title
Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
November 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Aleman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient cohort
Arm Type
Other
Arm Description
Patients with polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videcolonoscopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
Acetic acid % spray
Intervention 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.
Primary Outcome Measure Information:
Title
Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction
Description
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.
Time Frame
1 month
Title
Histopathology of resected polyps
Description
Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Histopathology impression of the endoscopist without acetic acid after resection.
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico E Bentolila, MD
Phone
54 11 48277000
Ext
2861
Email
fbentolila@hospitalaleman.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cimmino, MD
Organizational Affiliation
ENDIBA SAGE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Aleman
City
Caba
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ahumada, MD
Phone
54 11 4827 7000
Ext
2861
Email
cahumada@hospitalaleman.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29905183
Citation
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. No abstract available.
Results Reference
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Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

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