Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06423105 |
| Other study ID # |
NO.SWYX2024-225 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2013 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Shandong Provincial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The problem of false-negative lymph nodes in the central region (CLN) refers to the inability
to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is
confirmed by surgical and postoperative pathological examination. According to this study,
the false-negative rate of CLN of patients with TC was relatively high at approximately
71.7%. The high proportion of false-negatives indicates limitations in the sensitivity of
ultrasound examination, especially for detecting small LN or small metastases. The presence
of false-negative CLN directly affects clinical practice. First, it may lead to insufficient
selection of treatment strategies for patients with TC, thereby affecting their prognosis.
Second, such false-negative results may lead surgeons to overly trust ultrasound examination
during preoperative evaluation, neglecting the importance of comprehensive clinical
information, and thus affecting the formulation of treatment plans. This study aimed to
explore the factors influencing false-negative CLN through a cohort study and to establish a
predictive model.
Description:
Setting and Population This study collected 6369 patients admitted to the Breast and Thyroid
Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023,
who were diagnosed with TC through postoperative pathology. (SDC, Figure 1) All patients
included in the study signed a written informed consent form before surgery. Ethical approval
for this study (NO.SWYX2024-225) was provided by the Ethical Committee of Shandong Provincial
Hospital, Jinan, China on 15 April 2024. According to the relevant literature, the criteria
for identifying abnormal cervical LN under ultrasound are: disappearance of the LN hilum
structure or abnormalities in the skin and medulla, LN becoming round or having an increased
aspect ratio, microcalcifications in the LN, cystic changes present in LN, and abnormal blood
flow signals in LN.17 The inclusion and exclusion criteria are: all cases are newly diagnosed
TC cases; all cases underwent preoperative thyroid and neck LN examinations by the Ultrasound
Department of Shandong Provincial Hospital; all cases underwent thyroid surgery for the first
time; all cases were diagnosed with TC through postoperative pathological examination;
excluding cases of other combined tumors or major diseases. This study used the postoperative
paraffin pathology results as the gold standard for diagnostic testing. All ultrasound
examinations were performed by two ultrasound physicians. When two ultrasound physicians had
different opinions, a third senior ultrasound physician was requested to assist in the
evaluation.
Data Collection After obtaining written consent, we recorded the patient's relevant
information in detail and followed up on the patient's postoperative paraffin pathology
results. The collected and organized items included: 1) sex, age, and past medical history;
2) preoperative ultrasound information; 3) preoperative fine-needle biopsy information; 4)
surgical information; 5) postoperative pathological information; and 6) immunohistochemical
information.
Statistical Analysis This study first analyzed the baseline data of the included patients and
obtained descriptive data on the current status of patients with TC. (Table 1) This study
also analyzed the efficacy of ultrasound and fine-needle aspiration (FNA) for the evaluation
of cervical LN. (Table 2) Subsequently, analysis was conducted on 52 factors that may cause
false-negative CLN of TC. (Table 3) A total of 16 statistically significant influencing
factors were identified. (Table 4) To construct a predictive model for the occurrence of
false-negative CLN of the thyroid gland, we selected five preoperative influencing factors
with predictive significance from eight preoperative influencing factors and drew a forest
chart for data visualization and outcome prediction.
This study was analyzed using IBM SPSS 29.0 software. Quantitative data are represented by
mean ± standard deviation when it follows a normal distribution and homogeneity of variance,
and an independent sample t-test is used for comparison between the two groups; the median
(P25, P75) is used to represent non-normal distributions, and a non-parametric Mann-Whitney
test is used for comparison between the two groups. Qualitative data were expressed as
percentages (%), and intergroup comparisons were conducted using the chi-square or
Fisher's exact test. Variables with statistical significance in the univariate analysis
and those professionally considered to have an impact on the outcome were included in the
logistic regression model to explore the independent factors influencing the outcome. The
test level P was set at 0.05. A forest map was drawn using Graphpad Prism 10.12 software, and
a column chart and credibility analysis were drawn using R Studio 4.3 software.
