Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

NCT04157803 | Unknown

• 1 other identifier: HAleman
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (2)

• 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

• Histopathology of resected polyps

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

  1 month

Secondary Outcomes (1)

• Histopathology impression of the endoscopist without acetic acid after resection.

  1 month

Study Arms (1)

Patient cohort

OTHER

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

Diagnostic Test: Acetic acid % spray

Interventions

Acetic acid % spray DIAGNOSTIC_TEST

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.

Patient cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known acetic acid allergy
• Known or documented history of adenomatous or serrated polyposis
• Patients with inflammatory bowel disease

Sponsors & Collaborators

• Hospital Aleman: lead

Study Sites (1)

Hospital Aleman

CABA, C1118AAT, Argentina

RECRUITING

Related 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. No abstract available.

  PMID: 29905183 RESULT

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Cimmino, MD

  ENDIBA SAGE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico E Bentolila, MD

CONTACT

54 11 48277000; fbentolila@hospitalaleman.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 8, 2019
• Study Start: October 25, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)