Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images

Completed

• Conditions: Papillary Thyroid Carcinoma; Lymph Node Metastasis
• Interventions: Procedure: Thyroidectomy and lymph node dissection

• Registration Number: NCT06399159
• Lead Sponsor: Nanchong Central Hospital

Brief Summary

Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.

Detailed Description

Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01
• Study First Submitted: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-03
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
• Completed US examination within one week before surgery
• Underwent preoperative us-guided FNAC
• Completed cytological images at 400× magnification under a microscope

Exclusion Criteria

• Patients who underwent only unilateral thyroidectomy
• Patients with cervical lymph nodes shown on preoperative ultrasound

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort without Lymph Node Metastasis	Thyroidectomy and lymph node dissection	Depending on the pathological findings, it is classified as the absence of lymph node metastases.
Cohort with Lymph Node Metastasis	Thyroidectomy and lymph node dissection	Depending on the pathological findings, it is classified as the presence of lymph node metastases.

Primary Outcome Measures

Name	Time	Method
Presence or absence of lymph node metastasis	October 2024	All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.

Trial Locations

Locations (1)

Nanchong central hospital; 🇨🇳 Nanchong, Sichuan, China