Prophylactic central neck dissection for low-risk papillary thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of prophylactic central neck dissection in patients with low-risk papillary thyroid carcinoma (PTC). It aims to determine whether this surgical intervention can improve disease-specific survival and reduce local recurrence rates in patients with small thyroid nodules. The study involves a multicenter, randomized controlled design, focusing on patients aged 18-70 with specific eligibility criteria related to tumor size and absence of lymph node involvement. Participants will undergo surgery to assess the potential benefits of this approach in managing PTC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- (1)Patients age 18-70 years old, ECOG score 0-2; (2)Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2) and with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" or with intraoperative frozen section analysis "papillary thyroid carcinoma" .

(3)cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound performed by the center's designated radiologist according to a standardized report, no gross extrathyroidal extension was found before or during the surgery; (4)No serious medical disease and dysfunction of major organs, such as blood routine, liver, kidney, heart, and lung function; no previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass resection except clinical); (5)Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.

Exclusion Criteria:

-(1)History of malignancy in other sites (previous or concurrent), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; (2)Tumors \> 40 mm (cT3) or ≤ 10 mm; tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively; (3)Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed.Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis.

(4)No papillary thyroid carcinoma on FNAB cytology and/or high-risk subtype PTC; (5)Pregnant or breast feeding women (6)Participation in another therapeutic clinical trial within four months from study entry

Where it's running

• Cancer Hospital, Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: jie liu
• Email: liujie10-11@vip.163.com
• Phone: +861087787180

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.