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

Primary Purpose

Colonic Polyps

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NBI + Acetic Acid (AA)
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyps

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • indication for colonoscopy

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Routine colonoscopy Cohort

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic test: Optical characterization of colon polyps
Optical diagnosis of polyp histology will be assessed within a period of 2 weeks

Secondary Outcome Measures

Full Information

First Posted
April 23, 2016
Last Updated
April 8, 2017
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02760381
Brief Title
Acetic Acid for Optical Characterization of Colonic Polyps
Acronym
ATOMIC I
Official Title
Acetic Acid for Optical Characterization of Colonic Polyps: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine colonoscopy Cohort
Arm Type
Experimental
Arm Description
Patients receiving routine colonoscopy receive the intervention: NBI + Acetic Acid (AA)
Intervention Type
Device
Intervention Name(s)
NBI + Acetic Acid (AA)
Intervention Description
Patients belonging to the Routine colonoscopy Cohort will receive NBI + Acetic Acid (AA) chromoendoscopy for optical predictions of colonic polyps.
Primary Outcome Measure Information:
Title
Diagnostic test: Optical characterization of colon polyps
Description
Optical diagnosis of polyp histology will be assessed within a period of 2 weeks
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indication for colonoscopy Exclusion Criteria: pregnant women emergency investigation history of inflammatory bowel disease contraindication for polyp resection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Klare, MD
Phone
+ 49 89 4140
Ext
9340
Email
peter.klare@tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan von Delius, Prof.
Phone
+ 49 89 4140
Ext
5973
Email
stefan_ruckert@yahoo.de
Facility Information:
Facility Name
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
Phone
+49 89 4140
Ext
9340
Email
peter.klare@tum.de
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, Prof.
Phone
+ 49 89 4140
Ext
5973
Email
stefan_ruckert@yahoo.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acetic Acid for Optical Characterization of Colonic Polyps

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