A Randomized Controlled Clinical Study on the Accuracy of Linear Endoscopic Ultrasonography and Magnifying Narrowband Endoscopy in the Diagnosis of Invasive Depth of Early Rectal Cancer

1. Research purpose. 1.1 main purpose: to provide a more accurate preoperative evaluation method for the selection of surgical methods for early rectal cancer by comparing the accuracy of linear endoscopic ultrasonography and magnifying narrowband endoscopy in the diagnosis of invasive depth of early rectal cancer.

1.2 Secondary purpose: to compare the sensitivity, specificity and examination time of linear endoscopic ultrasonography and magnified narrowband endoscopy in the diagnosis of invasive depth of early rectal cancer. 2. Experimental design. This study is a single-center randomized, self-controlled clinical trial. The subjects were selected according to the inclusion and exclusion criteria, and all subjects who met the inclusion criteria were required to sign an informed consent form before joining the group. The team of doctors is composed of four experienced endoscopes from the Department of Gastroenterology of Nanfang Hospital. Patients were randomly divided into group A (patients underwent linear endoscopic ultrasonography followed by magnifying narrowband endoscopy) and group B (patients underwent magnifying narrowband endoscopy first and then linear endoscopic ultrasonography). The examination results, examination time and complications were recorded in both groups. After examination, continue to follow up the patient's operation until the patient's surgical and pathological results are obtained.

The main observation indicators of this clinical study include the accuracy of linear endoscopic ultrasonography and magnifying narrowband endoscopy in the diagnosis of the invasive depth of early rectal cancer, in which the surgical and pathological results are the gold standard, and the examination time of the two methods are also compared. 3. data analysis. After examination, continue to follow up the patient's operation until the patient's surgical and pathological results are obtained. Patients who did not undergo surgery and patients whose surgical and pathological results were not consistent with rectal cancer were excluded. The remaining patients took the pathological results as the gold standard to calculate the accuracy, sensitivity and specificity of linear endoscopic ultrasonography and endoscopic narrowband imaging in the diagnosis of invasive depth of early rectal cancer, and the results were statistically analyzed by chi-square test. 4. Safety monitoring, reporting and medical treatment. 4.1 adverse event (AE) definition. An adverse event refers to any adverse medical event that occurs after the patient or subject is examined in this study, which does not necessarily have a causal relationship with the examination. Therefore, adverse events can be any adverse physical signs (including abnormal laboratory results), symptoms, or diseases associated with the use of this study test, regardless of whether or not there is a causal relationship with the study test. Adverse events include serious adverse events ((Serious Adverse Event, SAE)) and non-serious adverse events.

4.2 SAE definition.

SAE refers to medical events during clinical trials, such as requiring hospitalization or prolonging hospitalization, disability, affecting working ability, endangering life or death, leading to congenital deformities and so on. Includes the following medical events: