Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)

NCT01607255 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CLIN-10-11S
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to establish the superior effectiveness of combining chromoendoscopy with the water exchange method in detecting more proximal diminutive adenomas during screening colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical colonoscopy will minimize the risk of missed lesions. The improvement may translate into a remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher adenoma detection rate may minimize the burden of post screening colonoscopy interval colorectal cancers among the veteran population.

Conditions

Colorectal Neoplasms

Keywords

adenoma detection; screening colonoscopy; water exchange method; chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate

  Proximal diminutive adenoma detection rate (ADR) in screening colonoscopy performed with the unusual air method, versus the water (exchange) method and with dye added to the water (exchange) method

  36 months

Study Arms (3)

water (exchange) method

EXPERIMENTAL

Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.

Procedure: water (exchange) method

water (exchange) plus dye method

EXPERIMENTAL

Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions

Drug: Indigo carmine; Procedure: water (exchange) plus dye method

air method

ACTIVE COMPARATOR

The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.

Procedure: air method

Interventions

Indigo carmine DRUG

0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy

water (exchange) plus dye method

water (exchange) method PROCEDURE

Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.

water (exchange) method

water (exchange) plus dye method PROCEDURE

Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions

water (exchange) plus dye method

air method PROCEDURE

The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.

air method

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asymptomatic Veterans scheduled for first time screening colonoscopy and agree to be randomized will be enrolled.

You may not qualify if:

• patients who decline to be randomized, non screening cases.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

Related Publications (13)

• Leung JW, Ransibrahmanakul K, Toomsen L, Mann SK, Siao-Salera R, Leung FW. The water method combined with chromoendoscopy enhances adenoma detection. J Interv Gastroenterol. 2011 Apr;1(2):53-58. doi: 10.4161/jig.1.2.16827.

  PMID: 21776426 BACKGROUND

• Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G. The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. doi: 10.4161/jig.1.2.16826.

  PMID: 21776425 BACKGROUND

• Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7. doi: 10.4161/jig.1.1.14585.

  PMID: 21686105 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 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 JW, Thai A, Yen A, Ward G, Abramyan O, Lee J, Smith B, Leung F. Magnetic endoscope imaging (ScopeGuide) elucidates the mechanism of action of the pain-alleviating impact of water exchange colonoscopy - attenuation of loop formation. J Interv Gastroenterol. 2012 Jul;2(3):142-146. doi: 10.4161/jig.23738. Epub 2012 Jul 1.

  PMID: 23805397 BACKGROUND

• Yen AW, Leung JW, Leung FW. A new method for screening and surveillance colonoscopy: Combined water-exchange and cap-assisted colonoscopy. J Interv Gastroenterol. 2012 Jul;2(3):114-119. doi: 10.4161/jig.23730. Epub 2012 Jul 1.

  PMID: 23805389 BACKGROUND

• Yen AW, Leung JW, Leung FW. A novel method with significant impact on adenoma detection: combined water-exchange and cap-assisted colonoscopy. Gastrointest Endosc. 2013 Jun;77(6):944-8. doi: 10.1016/j.gie.2013.01.011. Epub 2013 Mar 6.

  PMID: 23473001 BACKGROUND

• Leung JW, Siao-Salera R, Abramyan O, Mann SK, Ward G, Yen A, Gutierrez R, Leung FW. Impact of water exchange colonoscopy on serum sodium and potassium levels: an observational study. Dig Dis Sci. 2014 Mar;59(3):653-7. doi: 10.1007/s10620-013-2934-0. Epub 2013 Nov 20.

  PMID: 24254340 BACKGROUND

• Ngo C, Leung JW, Mann SK, Terrado C, Bowlus C, Ingram D, Leung FW. Interim report of a randomized cross-over study comparing clinical performance of novice trainee endoscopists using conventional air insufflation versus warm water infusion colonoscopy. J Interv Gastroenterol. 2012 Jul;2(3):135-139. doi: 10.4161/jig.23736. Epub 2012 Jul 1.

  PMID: 23805395 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 BACKGROUND

• Leung FW, Pan Y, Mann SK, Leung JW, Siao-Salera RM, Jackson G. The water exchange method and difficult colonoscopy. J Interv Gastroenterol. 2012 Jul;2(3):103-105. doi: 10.4161/jig.23727. Epub 2012 Jul 1. No abstract available.

  PMID: 23805386 BACKGROUND

• Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.

  PMID: 22163081 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Indigo Carmine; Water; Methods

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)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Investigative Techniques

Limitations and Caveats

The limitations and caveat of this clinical study are: single center, single blinded (patients) study, single operator, and Veteran patients.

Results Point of Contact

• Title: Joseph W. Leung, MD, Chief of Gastroenterology
• Organization: VA Northern California Healthcare Systems - Mather

Joseph.Leung2@va.gov

916-366-5339

Study Officials

• Joseph W. Leung, MD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 30, 2012
• Study Start: May 16, 2013
• Primary Completion: June 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)