Acetic Acid Colonoscopy Enhancement Study

Colorectal Cancer Clinical Trial

Official title:

Acetic Acid Colonoscopy Enhancement Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02231385
• Other study ID #: The "ACE" Study
• Status: Not yet recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: September 1, 2014
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2014
• Source: Istituto Clinico Humanitas
• Contact: Alessandro Repici, MD
• Phone: +390282247493
• Email: alessandro.repici[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colon Nos Polypectomy Tubular Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Serrated Adenomas

Intervention

Drug:
• Acetic Acid
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.

Locations

Country	Name	City	State
Italy	Nuovo Regina Margherita Hospital	Rome
Italy	Humanitas Research Hospital	Rozzano, Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Nuovo Regina Margherita Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Secondary	- Number of new adenoma detected at second right colon examination in both studies group		12 months	No
Secondary	Number of overall serrated and/or adenomatous lesions in the whole colon		12 months	No
Secondary	Characteristic of lesions detected (size, morphology)		12 months	No
Secondary	Complication rate		12 months	No