Combined Chromoendoscopy and Water Method for Screening Colonoscopy

NCT01383265 | Completed

• 1 other identifier: VANCHCS-GI-006
• Study Type: interventional
• Target: 1,177
• Locations: 1 country
• Sites: 1

Brief Summary

In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).

Conditions

Colon Polyp

Keywords

screening colonoscopy; adenoma; water method

Outcome Measures

Primary Outcomes (1)

• Diagnosis of adenoma

  24 months

Study Arms (2)

Water method and chromoendoscopy

EXPERIMENTAL

Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy

Procedure: Water method and chromoendoscopy

Water method

ACTIVE COMPARATOR

Control method will use plain water with the water method for screening colonoscopy

Procedure: Water method

Interventions

Water method and chromoendoscopy PROCEDURE

Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy

Also known as: Water method, Chromoendoscopy, Screening colonoscopy

Water method and chromoendoscopy

Water method PROCEDURE

Control method will use plain water with water method for screening colonoscopy

Also known as: Screening colonoscopy

Water method

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥50 years old
• Male and female patients
• Scheduled for screening colonoscopy
• Consented and accept randomization to study or control method

You may not qualify if:

• Patients who decline to participate
• Unable to give informed consent
• Unable to complete questionnaires due to language or other difficulties

Sponsors & Collaborators

• VA Northern California Health Care System: lead

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Related Publications (3)

• Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

  PMID: 19555938 BACKGROUND

• Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.

  PMID: 21184876 BACKGROUND

• Leung J, Mann S, Siao-Salera R, Ngo C, McCreery R, Canete W, Leung F. Indigocarmine added to the water exchange method enhances adenoma detection - a RCT. J Interv Gastroenterol. 2012 Jul;2(3):106-111. doi: 10.4161/jig.23728. Epub 2012 Jul 1.

  PMID: 23805387 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Joseph Leung, MD

  Sacramento VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

US (1)