Trial Outcomes & Findings for Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT) (NCT NCT01607255)
NCT ID: NCT01607255
Last Updated: 2019-01-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
480 participants
Primary outcome timeframe
36 months
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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
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
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
|
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
160
|
159
|
|
Overall Study
COMPLETED
|
161
|
160
|
159
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
Baseline characteristics by cohort
| Measure |
Water (Exchange) Method
n=161 Participants
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: 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) Plus Dye Method
n=160 Participants
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
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
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
|
Air Method
n=159 Participants
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: 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.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
415 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
441 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
161 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
480 Participants
n=4 Participants
|
|
BMI
|
29.6 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 36 monthsProximal 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
Outcome measures
| Measure |
Water (Exchange) Method
n=161 Participants
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: 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) Plus Dye Method
n=160 Participants
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
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
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
|
Air Method
n=159 Participants
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: 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.
|
|---|---|---|---|
|
Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate
Proximal ADR
|
86 participants
|
89 participants
|
83 participants
|
|
Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate
Serrated Lesion
|
38 participants
|
42 participants
|
18 participants
|
Adverse Events
Water (Exchange) Method
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Water (Exchange) Plus Dye Method
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Air Method
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Water (Exchange) Method
n=161 participants at risk
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: 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) Plus Dye Method
n=160 participants at risk
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
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
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
|
Air Method
n=159 participants at risk
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: 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.
|
|---|---|---|---|
|
Gastrointestinal disorders
post polypectomy abdominal pain
|
1.9%
3/161 • Number of events 3 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.62%
1/160 • Number of events 1 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.63%
1/159 • Number of events 1 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
|
Gastrointestinal disorders
post procedural bleeding
|
0.62%
1/161 • Number of events 1 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.62%
1/160 • Number of events 1 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.00%
0/159 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
|
Cardiac disorders
cardiovascular event
|
0.00%
0/161 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.62%
1/160 • Number of events 1 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
0.00%
0/159 • Immediate adverse event data were collected within 7 days and long-term complication data were collected at 30 days.
|
Other adverse events
Adverse event data not reported
Additional Information
Joseph W. Leung, MD, Chief of Gastroenterology
VA Northern California Healthcare Systems - Mather
Phone: 916-366-5339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place