Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02760381
Recruitment Status : Unknown
Verified April 2017 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Device: NBI + Acetic Acid (AA) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acetic Acid for Optical Characterization of Colonic Polyps: A Feasibility Study
Study Start Date : May 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication for colonoscopy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760381


Contacts
Layout table for location contacts
Contact: Peter Klare, MD + 49 89 4140 ext 9340 peter.klare@tum.de
Contact: Stefan von Delius, Prof. + 49 89 4140 ext 5973 stefan_ruckert@yahoo.de

Locations
Layout table for location information
Germany
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany Recruiting
Munich, Bayern, Germany, 81675
Contact: Peter Klare, MD    +49 89 4140 ext 9340    peter.klare@tum.de   
Contact: Stefan von Delius, Prof.    + 49 89 4140 ext 5973    stefan_ruckert@yahoo.de   
Sponsors and Collaborators
Technische Universität München

Layout table for additonal information
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02760381     History of Changes
Other Study ID Numbers: ATOMIC I
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents