Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesion
NCT ID: NCT05684328
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
840 participants
INTERVENTIONAL
2023-02-01
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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WLI Then NBI Withdrawal Group
After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by white light imaging(WLI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with narrow band imaging(NBI). Stop watch will be utilized to remind endoscopists.
WLI 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.
NBI Then WLI Withdrawal Group
After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by narrow band imaging(NBI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with white light imaging(WLI). Stop watch will be utilized to remind endoscopists.
NBI 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.
Interventions
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WLI 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.
NBI 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.
Eligibility Criteria
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Inclusion Criteria
* Patients who have indications for screening
* Patients who have signed inform consent form.
Exclusion Criteria
* 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
45 Years
85 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Dalian Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
Yantaishan Hospital
UNKNOWN
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
UNKNOWN
900 Hospital of Joint Logistics Support Force of PLA
OTHER
Heilongjiang provincial hospital
UNKNOWN
Ankang Central Hospital
OTHER
Nongken Jiansanjiang People Hospital of Heilongjiang Province
UNKNOWN
Huadong Hospital
OTHER
The Second Affiliated Hospital of Baotou Medical College
OTHER
Qilu Hospital, Shandong University
UNKNOWN
Shandong First Medical University
OTHER
Air Force Military Medical University, China
OTHER
Tengzhou Central People's Hospital
OTHER_GOV
Chongqing General Hospital
OTHER
Haikou People's Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Principal Investigators
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Zhaoshen Li, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
Li J, Zhang D, Wei Y, Chen K, Wu R, Peng K, Hou X, Li L, Huang C, Wang Y, Xun L, Xu H, Wang J, Chen Z, Shen M, Liu F. Colorectal Sessile Serrated Lesion Detection Using Linked Color Imaging: A Multicenter, Parallel Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):328-336.e2. doi: 10.1016/j.cgh.2022.03.033. Epub 2022 Apr 4.
Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
Other Identifiers
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NVWSDR-202212
Identifier Type: -
Identifier Source: org_study_id
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