Acetic Acid Colonoscopy Enhancement Study

NCT02231385 | Unknown

• 1 other identifier: The "ACE" Study
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Serrated Adenomas; Colon Nos Polypectomy Tubular Adenoma

Keywords

Colorectal cancer; Serrated adenomas; Screening; Adenoma detection rate; Polypectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• - Number of new adenoma detected at second right colon examination in both studies group

  12 months

• Number of overall serrated and/or adenomatous lesions in the whole colon

  12 months

• Characteristic of lesions detected (size, morphology)

  12 months

• Complication rate

  12 months

Study Arms (2)

Acetic Acid

EXPERIMENTAL

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.

Drug: Acetic Acid

Control Group

NO INTERVENTION

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.

Interventions

Acetic Acid DRUG

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.

Acetic Acid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Nuovo Regina Margherita Hospital: collaborator

Study Sites (2)

Nuovo Regina Margherita Hospital

Rome, 00153, Italy

Location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Alessandro Repici, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

• Cesare Hassan, MD

  Nuovo Regina Margherita Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Repici, MD

CONTACT

+390282247493; alessandro.repici@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

IT (2)