Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale

Condition(s) studied

Study summary

The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients.

Eligibility

Primary outcome measure(s)

• Height — up to three years
  The height indicator will summarize the data in "meters".
• Weight — up to three years
  The weight indicator will summarize data in "kilograms".
• Age — up to three years
  Age will be aggregated using "years" as the unit of measurement.
• Genders — up to three years
  Data will be summarized in terms of "male" and "female" as units of measurement.
• BMI — up to three years
  BMI will be summarized in "kg/m\^2".
• Whether lymph node dissection was performed during previous surgery — up to three years
  Data will be summarized using "yes" or "no" for whether lymph node dissection was performed during previous surgery.
• Tumor Diameter Size — up to three years
  Tumor diameter size will be summarized in "millimeters".
• Tumor limitation of the primary focus — up to three years
  Tumor limitation of primary foci will be summarized using "single/multiple" and "unilateral/bilateral".
• Extratumoral invasion — up to three years
  Extra-tumor focal invasion will be summarized with a "yes" or "no" to the data.
• Pathologic lymph node metastasis — up to three years
  Pathological lymph node metastases will be summarized with "yes" or "no" data.
• Tumor cystic solidity on preoperative ultrasound — up to three years
  Pre-operative ultrasound tumor cysticity will be summarized as "cystic" or "solid".
• Preoperative ultrasound tumor echo intensity — up to three years
  Preoperative ultrasound tumor echo intensity will be summarized as "high echo" or "moderate echo" or "low echo" or "very low echo".
• Preoperative ultrasound tumor boundaries — up to three years
  Preoperative ultrasound tumor boundaries will be summarized as "clear" or "unclear".
• Preoperative ultrasound tumor for the presence of calcifications — up to three years
  Preoperative ultrasound tumors will be summarized with "yes" or "no" for the presence of calcifications.
• Preoperative ultrasound tumor aspect ratios — up to three years
  Preoperative ultrasound tumor aspect ratios will be summarized with "\>1" or "\<1" data
• Preoperative ultrasound for enlarged cervical lymph nodes — up to three years
  Preoperative ultrasound of cervical lymph nodes for enlargement will be summarized as "yes" or "no".
• TSH — up to three years
  The TSH indicator will summarize data in "mlU/L".
• TPOAb — up to three years
  The TPOAb indicator will summarize data in "lU/mL".
• TgAb — up to three years
  The TgAb indicator will summarize data in "lU/mL".
• Calcium — up to three years
  The Calcium indicator will summarize data in "mmol/L".
• B-raf gene mutation — up to three years
  B-raf mutations will be summarized as "wild type" or "mutant".

Trial sites (1)

More Second Affiliated Hospital of Xi'an Jiaotong University trials in China

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