An interventional study of NBI in Diminutive Colorectal Polyps, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Diagnostic
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.
In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.
385 studies on the registry are indexed under Polyps; 59 are open to participants now.
This study's planned enrollment of 2,640 is above the median of 160 across 250 interventional studies indexed under Polyps.
Browse Polyps studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Device: NBI
optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
Time frame: Within two weeks after polypectomy
Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps
Time frame: Within two weeks after polypectomy
Plan to share: No
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine