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

Purpose

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.

Condition	Intervention
Colorectal Neoplasms	Drug: Indigo carmine Procedure: water (exchange) method Procedure: water (exchange) plus dye method Procedure: air method

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Comparative Efficacy of Water & Indigo Carmine vs Water or Air Method

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer Colonoscopy Colorectal Cancer Drinking Water

Drug Information available for: Indigotindisulfonate sodium Carmine

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Proximal diminutive (<10 mm) adenoma detection rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	480
Study Start Date:	January 2013
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: water (exchange) method 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 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.
Experimental: water (exchange) plus dye method 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 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy Procedure: water (exchange) plus dye method 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
Active Comparator: air method 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 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.

Detailed Description:

Design: Prospective, single center, patient blinded, randomized controlled trial
Methods: Colonoscopy with traditional air insufflation, water exchange or water exchange plus indigocarmine to aid insertion of colonoscope; split dose bowel preparation; all patients will receive sedation; assessment of serum electrolytes level before and after colonoscopy
1. Control method: Traditional air insufflation method.
2. Study methods:
  - Water exchange method.
  - Water method combined with chromoendoscopy (0.008% indigo carmine).
Population to be studied Veterans between age 50 and 75 referred for first time screening colonoscopy
Unit(s) of analysis
1. Primary outcome: overall adenoma detection rate.
2. Secondary outcomes: patient demographic variable and procedure related measures.
Sampling strategy: all veterans referred for screening colonoscopy will be offered enrollment in the study.
1. Sample size calculation. A total of 480 subjects will be recruited and randomized with 160 in each group.

5. Subject recruitment: patients referred for screening colonoscopy come from three sources.

6. Description of base population and groups to be studied and method of randomization.

Veterans between age 50 and 75 referred for first time screening colonoscopy. After informed consent, assignment to control or study arm based on computer generated random number codes stored in pre-arranged opaque envelopes.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients who decline to be randomized, non screening cases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607255

Contacts

Contact: Joseph W Leung	(916) 366-5339	Joseph.Leung2@va.gov
Contact: Felix W Leung	(818) 891-7711	Felix.Leung@va.gov

Locations

United States, California
VA Northern California Health Care System, Mather, CA	Not yet recruiting
Sacramento, California, United States, 95655
Contact: Joseph W Leung 916-366-5339 Joseph.Leung2@va.gov
Contact: Andrew Yen, MD (916) 366-5339 Andrew.Yen3@va.gov
Principal Investigator: Joseph W. Leung

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Joseph W. Leung

VA Northern California Health Care System, Mather, CA

More Information

Publications:

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. Epub 2011 Jul 1.

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.

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. PubMed PMID: 21776425; PubMed Central PMCID: PMC3136853.

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.

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.

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. Epub 2009 Jun 24.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT01607255 History of Changes
Other Study ID Numbers:	CLIN-10-11S
Study First Received:	May 24, 2012
Last Updated:	November 27, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

adenoma detection
screening colonoscopy
water exchange method
chromoendoscopy

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013