Trial Outcomes & Findings for Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps (NCT NCT02239536)

NCT ID: NCT02239536

Last Updated: 2020-04-14

Results Overview

Complete resection was defined as the absence of residual polyp in the resection margin

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 362 participants
• Primary outcome timeframe: 2 weeks after
• Results posted on: 2020-04-14

Participant Flow

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.

Participant milestones

Measure	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	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
Overall Study STARTED	190	172
Overall Study COMPLETED	167	155
Overall Study NOT COMPLETED	23	17

Reasons for withdrawal

Measure	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	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
Overall Study Non-neoplastic polyp	23	17

Baseline Characteristics

Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps

Baseline characteristics by cohort

Measure	Hot Snare Polypectomy n=167 Participants 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	Hot Snare Polypectomy(Saline Injection) n=155 Participants 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	Total n=322 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 10.7 • n=5 Participants	63.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	62.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex/Gender, Customized Male	114 participants n=5 Participants	98 participants n=7 Participants	212 participants n=5 Participants
Sex/Gender, Customized Female	53 participants n=5 Participants	57 participants n=7 Participants	110 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants	155 Participants n=7 Participants	322 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	167 Participants n=5 Participants	155 Participants n=7 Participants	322 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after

Complete resection was defined as the absence of residual polyp in the resection margin

Outcome measures

Measure	Hot Snare Polypectomy n=167 Participants 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	Hot Snare Polypectomy(Saline Injection) n=155 Participants 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
Complete Resection Rate Complete resection	161 Participants	148 Participants
Complete Resection Rate Incomplete resection	6 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 weeks after

Observation of maring on a recsected specimen

Outcome measures

Measure	Hot Snare Polypectomy n=167 Participants 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	Hot Snare Polypectomy(Saline Injection) n=155 Participants 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
Lateral Margin Negative	83 Participants	116 Participants
Lateral Margin Positive	3 Participants	2 Participants
Lateral Margin Inconclusive	91 Participants	37 Participants

Adverse Events

Hot Snare Polypectomy

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Hot Snare Polypectomy(Saline Injection)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hot Snare Polypectomy n=167 participants at risk 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	Hot Snare Polypectomy(Saline Injection) n=155 participants at risk 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
Gastrointestinal disorders Perforation	0.00% 0/167 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).	0.00% 0/155 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).

Other adverse events

Measure	Hot Snare Polypectomy n=167 participants at risk 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	Hot Snare Polypectomy(Saline Injection) n=155 participants at risk 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
Gastrointestinal disorders Immediate bleeding	10.2% 17/167 • Number of events 17 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).	7.7% 12/155 • Number of events 12 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
Gastrointestinal disorders Delayed bleeding	0.00% 0/167 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).	0.65% 1/155 • Number of events 1 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
Gastrointestinal disorders Post-polypectomy syndrome	0.00% 0/167 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).	0.00% 0/155 • 2 weeks after polypectomy Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).

Additional Information

Bo-In Lee

Seoul ST. Mary's hospital

Phone: 821083671055

Email: gidoc4u@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place