The Presence of Injured Submucosal Arteries After Cold Snare Polypectomy(CSP) is Lower Than That of Conventional Hot Snare Endoscopic Mucosal Resection (HS-EMR) for 10-19 mm Nonpedunculated Colorectal Polyps.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Showa Inan General Hospital
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- the presence of injured submucosal arteries detected in the submucosal layer.
Study Overview
Brief Summary
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CSP of 10-19 mm nonpedunculated colorectal polyps.
Detailed Description
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CS-EMR of 10-19 mm nonpedunculated colorectal polyps. The primary outcome measure was the presence of injured submucosal arteries detected in the submucosal layer. The secondary outcomes included immediate bleeding and the frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy. Immediate bleeding was defined as spurting or oozing which continued for more than 30 seconds.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •at least one polyp sized 10-19 mm (Paris classification Is or IIa) revealed by endoscopic examination.
Exclusion Criteria
- •American Society of Anesthesiologists status class 3 or above
- •poor bowel preparation (Boston Bowel Preparation Scale <6 points)
- •endoscopic features indicating submucous infiltration or malignancy
- •oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
- •a history of colorectal resection
- •emergent colonoscopy (haemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients)
- •inflammatory bowel disease, familial polyposis and colorectal cancer
- •pregnancy or lactation
- •severe cardiopulmonary dysfunction, cirrhosis, chronic kidney disease, other malignant tumours or severe infectious diseases.
Arms & Interventions
HS-EMR
Intervention: Active Comparator HS-EMR (Procedure)
CSP
Intervention: Experimental CSP (Procedure)
Outcomes
Primary Outcomes
the presence of injured submucosal arteries detected in the submucosal layer.
Time Frame: 1 day
the presence of injured submucosal arteries detected in the submucosal layer.
Secondary Outcomes
- One-year adenoma recurrence rate(1 year)
- Delayed bleeding(14 days)
- Immediate bleedling(1 day)
Investigators
Akira Horiuchi
Chief
Showa Inan General Hospital