Frozen Section-Guided Selective Ipsilateral Central Neck Dissection in Bethesda V-VI Thyroid Nodules: A Pilot Cohort Study Informing Surgical Extent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
The goal of this observational pilot cohort study is to evaluate the feasibility and clinical implications of frozen section analysis-guided selective ipsilateral central neck dissection in adult patients undergoing primary thyroid surgery for Bethesda V-VI thyroid nodules with a clinically node-negative neck.
The main questions it aims to answer are:
- Can intraoperative frozen section analysis of ipsilateral level VI lymph nodes meaningfully inform real-time surgical decision-making?
- Can this strategy support tailored escalation or de-escalation of central compartment surgery while minimizing unnecessary bilateral central neck dissection and its associated morbidity? Researchers will compare patients managed with ipsilateral central neck dissection and intraoperative frozen section analysis with patients managed without frozen section analysis, in order to evaluate differences in treatment adequacy, surgical decision-making, and pathological nodal assessment.
Participants will undergo primary thyroid surgery according to institutional practice. In patients managed with the frozen section analysis-guided strategy, one or more ipsilateral level VI lymph nodes will be removed during surgery and examined intraoperatively. The result of frozen section analysis may be used to guide the extent of central compartment surgery and the overall surgical strategy.
详细描述
This observational retrospective cohort study was conducted in a tertiary referral endocrine surgery unit and was based on prospectively collected institutional data. The study included consecutive adult patients undergoing primary thyroid surgery for cytologically suspicious or malignant thyroid nodules, classified as Bethesda V or VI according to the Bethesda System for Reporting Thyroid Cytopathology.
The study was designed to evaluate whether an intraoperative strategy based on ipsilateral central neck dissection (ipsiCND) with frozen section analysis (FSA) could improve the adequacy of surgical treatment in selected patients with low-risk thyroid cancer, potentially reducing both overtreatment and undertreatment. The institutional protocol incorporating ipsiCND-FSA was introduced in September 2023. Patients treated before implementation of this protocol generally underwent total thyroidectomy according to the standard institutional practice in place at that time. After implementation of the protocol, hemithyroidectomy combined with ipsilateral central neck lymph node sampling and intraoperative frozen section analysis was systematically proposed as the preferred surgical strategy in appropriately selected patients. Total thyroidectomy remained an option for patients who declined the conservative approach after counselling regarding the malignant or suspicious nature of the thyroid nodule and the available surgical alternatives.
Eligible patients were adults aged 18 years or older with a solitary thyroid nodule measuring less than 2.5 cm in maximum diameter, classified as Bethesda V or VI on preoperative cytology, with a clinically node-negative neck documented by preoperative cervical ultrasound. Patients were considered only if they underwent primary thyroid surgery and had complete histopathological data available for the thyroid specimen and, when removed, central compartment lymph nodes. Patients with previous thyroid or neck surgery, known distant metastases at the time of surgery, incomplete clinical or pathological data relevant to the study endpoints, or reoperations such as completion thyroidectomy or secondary lymph node dissection were excluded.
All patients received detailed preoperative counselling and provided written informed consent before surgery. The information provided included the planned procedure, the possible need for intraoperative modification of the surgical strategy according to real-time findings and frozen section results, and the potential risks and benefits of the available surgical options. Patients also consented to the inclusion of their clinical and pathological data in the institutional database and to their use for research purposes. The study was conducted in accordance with the principles of the Declaration of Helsinki, followed good clinical practice standards, and was approved by the local Ethics Committee under protocol PA-1-RETRO-2026-TBD. Reporting was planned in accordance with the STROCCS recommendations for observational studies.
All surgical procedures were performed or supervised by experienced endocrine surgeons. Intraoperative nerve monitoring was routinely used in all cases as part of the standard institutional practice. The extent of thyroid surgery, either total thyroidectomy or lobectomy/isthmectomy, and the strategy for management of the central neck compartment were planned preoperatively according to cytological diagnosis, imaging findings, clinical risk profile, and institutional practice. In patients managed according to the ipsiCND-FSA protocol, the operative plan could be modified intraoperatively on the basis of frozen section findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older.
- •Adult patients undergoing primary thyroid surgery.
- •Preoperative thyroid cytology classified as Bethesda V or Bethesda VI according to the Bethesda System for Reporting Thyroid Cytopathology.
- •Presence of a solitary thyroid nodule.
- •Maximum nodule diameter less than 2.5 cm.
- •Low-risk thyroid nodule according to clinical, cytological, and ultrasound criteria.
- •Clinically node-negative neck, documented by preoperative cervical ultrasound.
- •Availability of complete histopathological report for the thyroid specimen.
- •Availability of complete histopathological report for central compartment lymph nodes, when removed.
- •Written informed consent for surgery and for the use of clinical and pathological data for research purposes.
排除标准
- •Age younger than 18 years.
- •Previous thyroid or neck surgery, including completion thyroidectomy or secondary lymph node dissection
- •Known cervical lymph node metastases or distant metastases at the time of surgery.
- •Thyroid nodule measuring 2.5 cm or more in maximum diameter.
- •Incomplete clinical and pathological data relevant to the study endpoints.
研究组 & 干预措施
non-FSA Group
Participants in the non-FSA group underwent total thyroidectomy according to the 2015 American Thyroid Association guidelines and the institutional standard practice. The surgical strategy was based on preoperative cytology, cervical ultrasound findings, clinical risk assessment, and multidisciplinary evaluation. Central compartment lymph node management was performed according to the surgeon's judgment and preoperative findings.
FSA Group
Participants in the FSA group underwent hemithyroidectomy with selective ipsilateral central neck dissection. One or more ipsilateral level VI lymph nodes were removed during surgery and submitted for intraoperative frozen section analysis (FSA). The frozen section result was used to inform real-time surgical decision-making and to guide possible escalation or de-escalation of the surgical strategy.
干预措施: Frozen section analysis (FSA) (Procedure)
结局指标
主要结局
未指定
次要结局
- Complications(From surgery to postoperative follow-up, approximately 30-60 days after surgery.)
研究者
Eleonora Lori, MD
Principal Investigator
University of Roma La Sapienza
