Adenomatous Polyp of Colon, Colo-rectal Cancer, Polyp of Colon
Conditions
Brief summary
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
Detailed description
The details of the proposed study are as follows: 1. Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon 2. Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon 3. Methods: 1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. 2. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift. 3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. 4. The polyp as well as well as the two biopsies are reviewed by a pathologist.
Interventions
DEVICEUse of EverLift
Use of EverLift for submucosal injection prior to polypectomy
DEVICEWithout use of EverLift
Without use of EverLift for submucosal injection prior to polypectomy
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 18 years or older * Polyps 4-9mm
Exclusion criteria
* Pregnant * Inflammatory bowel disease * Polyposis syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Polyps With Complete Resection | 2 weeks | The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Resection | During the procedure | The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups. |
| Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. | During the procedure (up to 10 minutes) | — |
| Number of Patients With Procedural Complications | 4 weeks (from procedure through 30 day follow-up) | Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality. |
Countries
United States
Participant flow
Pre-assignment details
Each polyp sized 4-9 mm underwent block randomization to being removed by cold snare polypectomy (CNP) with or without submucosal injection of EverLift™.
Participants by arm
| Arm | Count |
|---|---|
| Polypectomy With EverLift Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. | 105 |
| Polypectomy With EverLift Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. | 142 |
| Polypectomy Without EverLift Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. | 109 |
| Polypectomy Without EverLift Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. | 149 |
| Total | 505 |
Baseline characteristics
| Characteristic | Polypectomy With EverLift | Polypectomy Without EverLift | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 81 Participants | 82 Participants | 163 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 27 Participants | 51 Participants |
| Race/Ethnicity, Customized African American | 10 participants | 12 participants | 16 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic | 13 participants | 16 participants | 21 participants |
| Race/Ethnicity, Customized Other | 4 participants | 4 participants | 8 participants |
| Race/Ethnicity, Customized White | 75 participants | 74 participants | 109 participants |
| Region of Enrollment United States | 105 participants | 109 participants | 158 participants |
| Sex/Gender, Customized Female | 3 participants | 2 participants | 3 participants |
| Sex/Gender, Customized Male | 102 participants | 107 participants | 155 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 109 |
| other Total, other adverse events | 0 / 105 | 0 / 109 |
| serious Total, serious adverse events | 1 / 105 | 2 / 109 |
Outcome results
Primary
Number of Polyps With Complete Resection
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
Time frame: 2 weeks
Population: Participants with polyps randomized the respective procedure are included in the analysis
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Polypectomy With EverLift | Number of Polyps With Complete Resection | 140 Polyps |
| Polypectomy Without EverLift | Number of Polyps With Complete Resection | 145 Polyps |
p-value: 0.424t-test, 2 sided
Secondary
Number of Patients With Procedural Complications
Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.
Time frame: 4 weeks (from procedure through 30 day follow-up)
Population: Participants with polyps randomized the respective procedure are included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polypectomy With EverLift | Number of Patients With Procedural Complications | 1 Participants |
| Polypectomy Without EverLift | Number of Patients With Procedural Complications | 2 Participants |
Secondary
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
Time frame: During the procedure (up to 10 minutes)
Population: Participants with polyps randomized the respective procedure are included in the analysis
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Polypectomy With EverLift | Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. | 6 Polyps |
| Polypectomy Without EverLift | Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. | 5 Polyps |
p-value: 0.697Chi-squared
Secondary
Time to Resection
The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.
Time frame: During the procedure
Population: Participants with polyps randomized the respective procedure are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polypectomy With EverLift | Time to Resection | 109.8 Seconds | Standard Deviation 56 |
| Polypectomy Without EverLift | Time to Resection | 38.8 Seconds | Standard Deviation 54.5 |
p-value: <0.0001t-test, 2 sided