Polyp of Large Intestine
Conditions
Keywords
neoplastic colorectal polyp, hot snare polypectomy, hot snare polypectomy after saline injection
Brief summary
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.
Interventions
PROCEDUREhot snare polypectomy
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
PROCEDUREhot snare polypectomy after saline injection
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
Sponsors
St Vincent's Hospital
Incheon St.Mary's Hospital
Bo-In Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 30 * 5\ 10mm sized colorectal polyps * Informed consent
Exclusion criteria
* Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis) * Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy * ASA class III or more * Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Resection Rate | 2 weeks after | Complete resection was defined as the absence of residual polyp in the resection margin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Margin | 2 weeks after | Observation of maring on a recsected specimen |
Countries
South Korea
Participant flow
Recruitment details
Patients were excluded if they have (1) a bleeding tendency or ever taken antiplatelet or anticoagulation therapy within 1 week before undergoing the procedure, (2) An inflammatory bowel disease, (3) a polyposis syndrome, or (4) an inability to provide informed consent.
Participants by arm
| Arm | Count |
|---|---|
| Hot Snare Polypectomy Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps | 167 |
| Hot Snare Polypectomy(Saline Injection) Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps | 155 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Non-neoplastic polyp | 23 | 17 |
Baseline characteristics
| Characteristic | Total | Hot Snare Polypectomy(Saline Injection) | Hot Snare Polypectomy |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 10.7 | 63.0 years STANDARD_DEVIATION 10.8 | 62.8 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 322 Participants | 155 Participants | 167 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 322 Participants | 155 Participants | 167 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 110 participants | 57 participants | 53 participants |
| Sex/Gender, Customized Male | 212 participants | 98 participants | 114 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 155 |
| other Total, other adverse events | 17 / 167 | 13 / 155 |
| serious Total, serious adverse events | 0 / 167 | 0 / 155 |
Outcome results
Primary
Complete Resection Rate
Complete resection was defined as the absence of residual polyp in the resection margin
Time frame: 2 weeks after
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hot Snare Polypectomy | Complete Resection Rate | Complete resection | 161 Participants |
| Hot Snare Polypectomy | Complete Resection Rate | Incomplete resection | 6 Participants |
| Hot Snare Polypectomy(Saline Injection) | Complete Resection Rate | Complete resection | 148 Participants |
| Hot Snare Polypectomy(Saline Injection) | Complete Resection Rate | Incomplete resection | 7 Participants |
p-value: 0.05Chi-squared
Secondary
Lateral Margin
Observation of maring on a recsected specimen
Time frame: 2 weeks after
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hot Snare Polypectomy | Lateral Margin | Negative | 83 Participants |
| Hot Snare Polypectomy | Lateral Margin | Positive | 3 Participants |
| Hot Snare Polypectomy | Lateral Margin | Inconclusive | 91 Participants |
| Hot Snare Polypectomy(Saline Injection) | Lateral Margin | Negative | 116 Participants |
| Hot Snare Polypectomy(Saline Injection) | Lateral Margin | Positive | 2 Participants |
| Hot Snare Polypectomy(Saline Injection) | Lateral Margin | Inconclusive | 37 Participants |
p-value: 0.05Chi-squared
p-value: 0.001Chi-squared