Central Cervical Dissection for Clinical Node Negative Papillary Thyroid Carcinoma

Launched by ZHEJIANG UNIVERSITY · Jan 19, 2019

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the best way to treat patients with papillary thyroid carcinoma (PTC) who do not have any lymph node metastases, meaning the cancer has not spread to the lymph nodes. The study is divided into three stages. In the first stage, researchers will look at different imaging methods to create a standard for identifying these patients. They will then enroll 2,000 patients to test a prediction model that helps determine the likelihood of lymph node involvement. In the second stage, they will further refine this model using the same group of patients. The final stage will involve randomly dividing 2,000 patients who meet specific criteria into two groups: one group will receive a specific surgical procedure called central neck dissection (pCND), while the other will not. The researchers will follow these patients for many years to see how well the prediction model works and how the different treatments affect their health.

To be eligible for this trial, participants need to be between 18 and 80 years old, have a localized thyroid tumor that is less than 4 centimeters in size, and have no signs of lymph node metastasis based on imaging tests. It's important to note that this trial is not yet recruiting participants, so individuals interested in joining will need to wait. Those who participate will have the chance to contribute to an important study that may help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Phase I and II:
• • 1. aged 18 to 80 years old;
• • 2. the primary treatment of patients with unilateral or bilateral PTC;
• • 3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
• • 4. ultrasonography of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no local or global echo enhancement;
• • 5. CT scan of cervical VI lymph nodes: the shortest diameter \< 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution;
• • 6. patients will voluntarily enter the study after informed consent;
• Phase III:
• • 1. aged from 18 to 80 years old;
• • 2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm;
• • 3. Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model";
• • 4. patients will voluntarily enter the study after informed consent.
• Exclusion Criteria:
• • (1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma.