NCT03813173

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma: a Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into three stages. In the first stage, the investigators try to explore the objective clinical imaging standard of cN0PTC on the basis of previous studies, formulate the "clinical imaging standard of cN0PTC", and randomly enroll 2000 patients under the premise of meeting the standard to establish the "predictive model of cN0-pN+PTC". In the second stage, 2000 patients will be enrolled to test and improve the evaluation efficiency of "cN0-pN+PTC prediction model". In the third stage, 2 000 patients without lymph node metastasis assessed by "cNo-pN+ PTC prediction model" will be randomly divided into experimental group and control group. The experimental group will be treated with pCND, while the experimental group will be treated without pCND. The central lymph node metastasis probability, the number and size of metastatic lymph nodes in the control group will be observed after operation. The two groups will be followed up for 5, 10, 15 and 20 years to observe the RFS and OS, so as to further evaluate the "cN0-pN+PTC prediction model" scientifically.

Conditions

• Lymph Node Metastases

Interventions

Type	Name	Description
PROCEDURE	lymph node dissection	The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.

Timeline

• Start date: 2020-01-01
• Primary completion: 2040-12-01
• Completion: 2040-12-01
• First posted: 2019-01-23
• Last updated: 2019-07-05