Acetic Acid for Optical Characterization of Colonic Polyps

NCT02760381 | Unknown

• 1 other identifier: ATOMIC I
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Routine colonoscopy Cohort

EXPERIMENTAL

Patients receiving routine colonoscopy receive the intervention: NBI + Acetic Acid (AA)

Device: NBI + Acetic Acid (AA)

Interventions

NBI + Acetic Acid (AA) DEVICE

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

Routine colonoscopy Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Peter Klare, MD

CONTACT

+ 49 89 4140; peter.klare@tum.de

Stefan von Delius, Prof.

CONTACT

+ 49 89 4140; stefan_ruckert@yahoo.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: May 3, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: August 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)