Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 1,156
Study Overview
Brief Summary
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).
- •Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.
- •Signed informed consent.
Exclusion Criteria
- •Refusal or lack of informed consent.
- •Polyp size ≥25 mm or fragmented resection.
- •Severe specimen damage/cautery artifact or time from resection to fixation >30 min.
- •Suspected/confirmed CRC, IBD, or polyposis syndromes.
- •Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.
Investigators
Zhaoshen Li
MD,Director, Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Changhai Hospital