Sessile Serrated Lesion
Conditions
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.
Interventions
DEVICEPolyp Pretreatment Device
This novel polyp pretreatment device is a single-use, non-invasive laboratory tool designed to standardize the orientation and fixation of resected colorectal polyp specimens. The device consists of a flat, rigid base with a transparent, non-adherent cover, and is engineered to maintain the mucosal surface of the polyp specimen flat and fully extended.
Sponsors
Changhai Hospital
Heilongjiang Provicial Hospital
Ankang Central Hospital
Huadong Hospital Affiliated with Fudan University, Shanghai
The First Affiliated Hospital of Nanchang University
Ya'an People's Hospital
The Second Hospital of Hebei Medical University
Chongqing General Hospital
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Shanxi Provincial People's Hospital
Shanghai Sixth Hospital
People's Hospital of Leshan, Sichuan Province
The Third People's Hospital of Chengdu
The Third People's Hospital of Jingdezhen
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Shandong Provincial Second People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple). 2. Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens. 3. Signed informed consent.
Exclusion criteria
1. Refusal or lack of informed consent. 2. Polyp size ≥25 mm or fragmented resection. 3. Severe specimen damage/cautery artifact or time from resection to fixation \>30 min. 4. Suspected/confirmed CRC, IBD, or polyposis syndromes. 5. Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SSL Diagnostic Rate (%) | 7 days |
Contacts
CONTACTZhaoshen Li
CONTACTYu Bai
Outcome results
None listed