Acetic Acid for Optical Characterization of Colonic Polyps (ATOMIC I)

April 8, 2017 updated by: Technical University of Munich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Recruiting
        • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for colonoscopy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine colonoscopy Cohort
Patients receiving routine colonoscopy receive the intervention: NBI + Acetic Acid (AA)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic test: Optical characterization of colon polyps
Time Frame: up to 2 weeks
Optical diagnosis of polyp histology will be assessed within a period of 2 weeks
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 23, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATOMIC I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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