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Acetic Acid for Optical Characterization of Colonic Polyps

Acetic Acid for Optical Characterization of Colonic Polyps: A Feasibility Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02760381
Acronym
ATOMIC I
Enrollment
55
Registered
2016-05-03
Start date
2016-05-31
Completion date
2017-08-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps

Brief summary

Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the colon. Currently all polyps should be resected endoscopically, however adenomas have the potential to develop into colorectal cancer whereas hyperplastic polyps do not. This approach enables the lesions to be evaluated under the microscope. Currently only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Acetic acid (AA) chromoendoscopy is already widely used in order to improve optical determination of mucosal lesions in the upper gastrointestinal tract. In the colon only few studies investigated the impact of AA in differentiating normal mucosa from suspicious mucosa. The aim of the present study is to evaluate the value of spraying acetic acid as an adjunct for optical characterization of colon polyps. Using AA may be beneficial for determining optical diagnoses of colon polyps during real time colonoscopy. This is a single-arm proof of principle study. If colon polyps are found during colonoscopy a 1.5 percent AA solution will be used for chromoendoscopy. Endoscopists are encouraged to use the Narrow Band Imaging (NBI) function of the endoscope prior to the use of AA. After AA is sprayed endoscopists will diagnose the polyp optically. Endoscopists have to predict adenomatous or non-adenomatous histology based upon optical features of the polyp. All polyps will be resected endoscopically so that histopathological diagnoses can be determined. After completing the trial the investigators aim to compare optical and histopathological-based diagnoses of polyps. Histopathological diagnoses will serve as the gold standard. Based upon this information the accuracy of the optical diagnoses will be calculated. The investigators hypothesis is, that optical-based diagnosis using NBI and AA will be accurate in \> 75% of all polyp cases.

Interventions

DEVICENBI + Acetic Acid (AA)

Patients belonging to the Routine colonoscopy Cohort will receive NBI + Acetic Acid (AA) chromoendoscopy for optical predictions of colonic polyps.

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* indication for colonoscopy

Exclusion criteria

* pregnant women * emergency investigation * history of inflammatory bowel disease * contraindication for polyp resection

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic test: Optical characterization of colon polypsup to 2 weeksOptical diagnosis of polyp histology will be assessed within a period of 2 weeks

Countries

Germany

Contacts

Primary ContactPeter Klare, MD
peter.klare@tum.de+ 49 89 4140
Backup ContactStefan von Delius, Prof.
stefan_ruckert@yahoo.de+ 49 89 4140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026