Quality Control The investigators' quality assurance plan is as follows. A. Once the plan has
been approved, it cannot be modified at will. If special circumstances such as difficulty in
implementation are found after the start of the study, the proposal may be revised or
supplemented by the discussion of the research group and the project leader, and the revised
content shall be recorded in writing.
The program change process is as follows:
Identify the problems and understand the necessary to change the plan;
Convene the main members of the research team and the project leader to discuss and
propose solutions;
Revise the plan and update the version number, fill out the "Program Description";
The revised plan and the "Revision of the Plan" need to be signed by the person in
charge of the project. If necessary, they must be submitted to the ethics committee for
approval or filing; if approved, the revised plan can be implemented.
B. In order to ensure that the research personnel have sufficient qualifications to undertake
specific research work, the research personnel should at least complete the following
training before the project starts:
Research object protection and ethical requirements;
Study protocols and related standard operating procedures (tracer injection methods, use
of near-infrared fluorescent vascular imagers, and pathology);
Case Report Form and gauge filling instructions (form entry criteria, surgical record
methods, etc.);
Clinical research project implementation considerations (such as research object
screening, enrollment, data collection process); Project-related training should be
carried out throughout the research process. The project leader and project coordinator
can increase the training content according to the situation, such as training on weak
links in the test, training on updating programs and various causes.
Data Management A. Case report form design The researcher is responsible for drafting the
research case report form. B. Data Entry and Data Verification According to the final version
of CRF, the project database is built using software. The data entry and verification is
carried out by a dedicated person.
Statistical Analysis A. Statistical Analysis Plan and Statistical Software After the trial
protocol is determined, the statistical professors and the main investigators are responsible
for developing a statistical analysis plan. The statistical analysis software uses SAS® 9.2
software (software installation point authorization number: 11202165).
B. Calculation and reasoning of sample size The sample size is calculated using PASS11
software; the sample size is estimated based on the negative prediction value of the previous
study, and the negative prediction value of SLNs is expected to be 95%; the allowable error
is 2% (the range of the confidence interval is 93% to 97%). When the significant level is
0.05, 508 cases are needed to be studied. Considering the detection rate of 80% of SLNs, a
total of 635 cases are expected to be studied.
C. Statistical Analysis Methods General principle Using a two-sided test, a P value of less
than 0.05 would be considered statistically significant.
The quantitative indicators will calculate the mean, standard deviation, median, minimum,
maximum, lower quartile (Q1), upper quartile (Q3), and the classification indicators will
describe the number of cases and percentages.
Comparison of clinicopathological features (age, body mass index, pathological type, tumor
stage, grading, maximum tumor diameter, invasive myometrial depth, lymphatic vascular
infiltration, and tracer method) for SLNs and undetected SLNs will be based on the type of
indicator. For the comparison of quantitative data between groups, the t-test or Wilcoxon
rank sum test will be used according to the data distribution. For the comparison of
categorical data between groups, the data will be analyzed by chi-square test or exact
probability method (if the chi-square test is not applicable). And the grade data was
analyzed by Wilcoxon rank sum test or CMH test.
Clinical diagnostic index calculation According to the true positive (TP), false negative
(FN), true negative (TN), and false positive (FP), the results of SLNs pathological
examination and all lymph node pathological examination results will be compared. The
comparison results will be plotted as a four-grid table to calculate sensitivity, false
negative rate, and negative predictive value, respectively.
Chi-square test or exact probability method (if the chi-square test is not applicable) will
be used to compare the clinical diagnosis value of SLNs biopsy of endometrial cancer patients
with injection of carbon nanoparticles (CNP) or combined injection of CNP and indocyanine
green(ICG).
Chi-square test or exact probability method (if the chi-square test is not applicable) will
be used to analyze the clinic-pathological factors affecting the detection rate of SLNs.