Colonic PolypAceticNCT04157803
Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps
A study testing Acetic acid % spray in people with Colonic Polyp, run by Hospital Aleman at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Acetic acid % spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 25 Oct 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with colonic polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.
Who cannot join
- Known acetic acid allergy
- Known or documented history of adenomatous or serrated polyposis
- Patients with inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Aleman
CABA, C1118AAT
Christian Ahumada, MD, 54 11 4827 7000 ext. 2861, cahumada@hospitalaleman.com
About this study
Official title: Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps
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.
Read the 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
- Conditions
- Colonic Polyp
- Being tested
- Acetic acid % spray
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic acid % sprayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Other | Patients with polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videcolonoscopy. Receives: Diagnostic Test: Acetic acid % spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Histopathology of resected polyps
Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start25 Oct 2019
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Aleman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Bentolila, Hospital Aleman
- Investigators
- Daniel Cimmino, MD, Principal investigator, ENDIBA SAGE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157803
- Sponsor's protocol ID
- HAleman
- Acronym
- Acetic
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29905183
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps
- ClinicalTrials.gov ID
- NCT04157803
- Acronym / sponsor ID
- Acetic / HAleman
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital AlemanUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | Other | Diagnostic Test: Acetic acid % sprayPatients with polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videcolonoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with colonic polyps> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.
Key exclusion criteria (3 listed)
- Known acetic acid allergy
- Known or documented history of adenomatous or serrated polyposis
- Patients with inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetic acid % sprayIf 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. | Diagnostic test | Patient cohort |
Primary outcome
Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction
Time frame: 1 month
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
Time frame: 1 month
Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.
1 secondary outcome
Histopathology impression of the endoscopist without acetic acid after resection.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Results publication: PubMed 29905183Popoutchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cimmino, MD principal investigator
ENDIBA SAGE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic acid % spray in people with Colonic Polyp, run by Hospital Aleman at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico E Bentolila, MD (54 11 48277000 ext. 2861, fbentolila@hospitalaleman.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.