Colorectal Sessile Serrated Lesion
Conditions
Brief summary
This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).
Interventions
PROCEDUREWLI Then LCI Withdrawal
Patients in the WLI then LCI withdrawal group first underwent careful endoscopic inspection with white-light imaging (WLI). The endoscopic setting was then switched to linked color imaging (LCI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.
PROCEDURELCI Then WLI Withdrawal
Patients in the LCI then WLI withdrawal group first underwent careful endoscopic inspection with linked color imaging (LCI). The endoscopic setting was then switched to white-light imaging (WLI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.
Sponsors
Nanfang Hospital, Southern Medical University
Shunde First People's Hospital of Foshan
ZhuHai Hospital
Jiangmen Central Hospital
Yangjiang People's Hospital
Zhongshan Guzhen People's Hospital
Sihui Wanlong Hospital
The Third People's Hospital of Huizhou
Longgang District People's Hospital of Shenzhen
Suixi People's Hospital of Zhanjiang
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged ≥45 years, regardless of gender; 2. Subjects undergoing screening colonoscopy; 3. Subjects with no prior colonoscopy; 4. Voluntarily provide written informed consent.
Exclusion criteria
1. Subjects unable to cooperate with or tolerate colonoscopy; 2. Subjects with inflammatory bowel disease; 3. Known or highly suspected colorectal obstruction; 4. History of colorectal surgery; 5. Chronic recurrent constipation; 6. Failure to discontinue anticoagulants or antiplatelet agents for at least 1 week before the procedure; 7. Poor bowel preparation with an inadequate Aronchick scale score during colonoscopy; 8. Failed cecal intubation; 9. High-risk conditions including severe cardiovascular and cerebrovascular diseases, uncorrected severe anemia or active infection; 10. Pregnant or breastfeeding women; 11. Subjects deemed ineligible for participation in this trial at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sessile serrated lesions miss rate(SSLMR) | One day | The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adenoma miss rate (AMR) | One day | The number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass. |
| advanced adenomas miss rate (AAMR) | One day | the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass. |
| polyps miss rate (PMR) | One day | the number of polyps detected in the second-pass examination/total number of polyps detected in the two pass. |
| sessile serrated lesions detection rate (SSLDR) | One day | the number of patients with at least one sessile serrated lesion detected by linked color imaging or white light imaging, divided by the total number of patients. |
| adenomas detection rate (ADR) | One day | the number of patients with at least one adenoma detected by linked color imaging or white light imaging, divided by the total number of patients. |
| advanced adenomas detection rate (AADR) | One day | the number of patients with at least one advanced adenoma detected by linked color imaging or white light imaging, divided by the total number of patients. |
| polyps detection rate (PDR) | One day | the number of patients with at least one polyp detected by linked color imaging or white light imaging, divided by the total number of patients. |
Contacts
CONTACTZelong Han, MD
CONTACTBitao Lin, MD
Outcome results
None listed