Colorectal Sessile Serrated Lesion
Conditions
Keywords
Sessile Serrated Lesions Miss Rate, Sessile Serrated Lesions Detection Rate, Narrow Band Imaging, Colonoscopy
Brief summary
Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. But no randomized controlled trials with NBI versus white light imaging(WLI) have been conducted to give a definitive conclusion with statistically significant differences. Therefore, we performed a multicenter, prospective, back to back, randomized controlled trial to compare sessile serrated lesions detection and miss rate of withdraw by NBI and WLI in colonoscopy.
Interventions
PROCEDUREWLI Then NBI Withdrawal
Patients in WLI then NBI withdrawal group will first be carefully inspected by white light imaging(WLI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to narrow band imaging(NBI) for the second withdraw to detect the lesions which found in second time but not the first.
PROCEDURENBI Then WLI Withdrawal
Patients in NBI then WLI withdrawal group will first be carefully inspected by narrow band imaging(NBI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to white light imaging(WLI) for the second withdraw to detect the lesions which found in second time but not the first.
Sponsors
The First Affiliated Hospital of Dalian Medical University
The Second Hospital of Hebei Medical University
Yantaishan Hospital
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
900 Hospital of Joint Logistics Support Force of PLA
Heilongjiang provincial hospital
Ankang Central Hospital
Nongken Jiansanjiang People Hospital of Heilongjiang Province
Huadong Hospital
The Second Affiliated Hospital of Baotou Medical College
Qilu Hospital, Shandong University
Shandong First Medical University
Air Force Military Medical University, China
Tengzhou Central People's Hospital
Chongqing General Hospital
Haikou People's Hospital
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose age are between 45-85 * Patients who have indications for screening * Patients who have signed inform consent form.
Exclusion criteria
* Patients who have undergone colonic resection * Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination * Patients with highly suspected or confirmed colorectal cancers by radiographic and laboratory tests * Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy * Patients with inflammatory bowel diseases * Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis). * Patients with pregnancy, severe chronic cardiopulmonary and renal disease. * Patients with therapeutic colonoscopy for existing lesions * Patients with failed cecal intubation * Patients with poor bowel preparation quality that necessitated a second bowel preparation * Patients refusing to participate or to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sessile serrated lesions miss rate(SSLMR) | 60 minutes | Sessile serrated lesions(SSLs) detected in the second-pass examination were defined as missed SSLs; the sessile serrated lesions miss rate(SSLMR) was defined as follows: number of SSLs detected in the second-pass examination/total number of SSLs detected in both two pass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sessile serrated lesions detection rate(SSLDR) | 60 minutes | Sessile serrated lesions detection rate(SSLDR) is the number of patients with at least one sessile serrated lesion detected by narrow band imaging or white light imaging, divided by the total number of patients. |
| adenoma miss rate(AMR) | 60 minutes | Adenomas detected in the second-pass examination were defined as missed adenomas; the adenoma miss rate(AMR) was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass. |
| adenoma detection rate(ADR) | 60 minutes | Adenoma detection rate(ADR) is the number of patients with at least one adenoma detected by narrow band imaging or white light imaging, divided by the total number of patients. |
Countries
China
Contacts
Primary ContactZhaoshen Li, MD
Backup ContactYu Bai, MD
Outcome results
None listed