Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Colon Polyp Clinical Trial

Official title:

Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383265
• Other study ID #: VANCHCS-GI-006
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: June 13, 2013
• Start date: March 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: VA Northern California Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Description:

Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described.

Aim: 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).

Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1177
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult (=50 years old

• Male and female patients

• Scheduled for screening colonoscopy

• Consented and accept randomization to study or control method

Exclusion Criteria:

• Patients who decline to participate

• Unable to give informed consent

• Unable to complete questionnaires due to language or other difficulties

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colon Polyp

Intervention

Procedure:
• Water method and chromoendoscopy
Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
• Water method
Control method will use plain water with water method for screening colonoscopy

Locations

Country	Name	City	State
United States	Sacramento VA Medical Center	Mather	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of adenoma		24 months	No