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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02760381
Other study ID # ATOMIC I
Secondary ID
Status Recruiting
Phase N/A
First received April 23, 2016
Last updated April 8, 2017
Start date May 2016
Est. completion date August 2017

Study information

Verified date April 2017
Source Technische Universität München
Contact Peter Klare, MD
Phone + 49 89 4140
Email peter.klare@tum.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date August 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- indication for colonoscopy

Exclusion Criteria:

- pregnant women

- emergency investigation

- history of inflammatory bowel disease

- contraindication for polyp resection

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany Munich Bayern

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic test: Optical characterization of colon polyps Optical diagnosis of polyp histology will be assessed within a period of 2 weeks up to 2 weeks
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