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Acetic Acid Colonoscopy Enhancement Study

Primary Purpose

Colorectal Cancer, Serrated Adenomas, Colon Nos Polypectomy Tubular Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acetic Acid
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal cancer, Serrated adenomas, Screening, Adenoma detection rate, Polypectomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patient is >40 years old
  2. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
  3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

  1. Patients with a history of colonic resection;
  2. Patients with inflammatory bowel disease;
  3. Patients with a personal history of polyposis syndrome;
  4. Patients with suspected chronic stricture potentially precluding complete colonoscopy;
  5. Patients with diverticulitis or toxic megacolon;
  6. Patients with a history of radiation therapy to abdomen or pelvis;
  7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Sites / Locations

  • Nuovo Regina Margherita Hospital
  • Humanitas Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acetic Acid

Control Group

Arm Description

Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.

Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.

Outcomes

Primary Outcome Measures

Additional serrated lesions diagnosed after acetic acid spraying
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes

Secondary Outcome Measures

- Number of new adenoma detected at second right colon examination in both studies group
Number of overall serrated and/or adenomatous lesions in the whole colon
Characteristic of lesions detected (size, morphology)
Complication rate

Full Information

First Posted
September 1, 2014
Last Updated
September 1, 2014
Sponsor
Istituto Clinico Humanitas
Collaborators
Nuovo Regina Margherita Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02231385
Brief Title
Acetic Acid Colonoscopy Enhancement Study
Official Title
Acetic Acid Colonoscopy Enhancement Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas
Collaborators
Nuovo Regina Margherita Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy. Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon. Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results. Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Serrated Adenomas, Colon Nos Polypectomy Tubular Adenoma
Keywords
Colorectal cancer, Serrated adenomas, Screening, Adenoma detection rate, Polypectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetic Acid
Arm Type
Experimental
Arm Description
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Intervention Type
Drug
Intervention Name(s)
Acetic Acid
Intervention Description
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Primary Outcome Measure Information:
Title
Additional serrated lesions diagnosed after acetic acid spraying
Description
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
- Number of new adenoma detected at second right colon examination in both studies group
Time Frame
12 months
Title
Number of overall serrated and/or adenomatous lesions in the whole colon
Time Frame
12 months
Title
Characteristic of lesions detected (size, morphology)
Time Frame
12 months
Title
Complication rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient is >40 years old The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; The patient must understand and provide written consent for the procedure. Exclusion Criteria: Patients with a history of colonic resection; Patients with inflammatory bowel disease; Patients with a personal history of polyposis syndrome; Patients with suspected chronic stricture potentially precluding complete colonoscopy; Patients with diverticulitis or toxic megacolon; Patients with a history of radiation therapy to abdomen or pelvis; Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Repici, MD
Phone
+390282247493
Email
alessandro.repici@humanitas.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD
Organizational Affiliation
Humanitas Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cesare Hassan, MD
Organizational Affiliation
Nuovo Regina Margherita Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuovo Regina Margherita Hospital
City
Rome
ZIP/Postal Code
00153
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesare Hassan, MD
Phone
+3906 77301
Email
cesareh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Cesare Hassan, MD
Facility Name
Humanitas Research Hospital
City
Rozzano, Milan
ZIP/Postal Code
20089
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD
Phone
+390282247493
Email
alessandro.repici@humanitas.it
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD

12. IPD Sharing Statement

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Acetic Acid Colonoscopy Enhancement Study

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