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NCT Number: NCT04666103

Function Integrity of Neck Anatomy in Thyroid Surgery

Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment.

Thermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.

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Key information

Conditions

Thyroid Carcinoma Ablation; Retina Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodule (Benign)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location status: Recruiting

Location contact

Qianqian Yuan, MD.

CONTACT

[email protected]

+8613026322297

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology;
  • Patients with contralateral nodules ≤ 20mm and located in the thyroid gland;
  • Patients with clinical node-negative cervical compartment at palpation and neck ultrasound.

Exclusion criteria

  • Previous history of neck surgery
  • Previous history of neck radiation therapy

Treatment and study plan

Intraoperative thermal ablation

Procedure

After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The "hydrodissection technique'' was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy.

Primary outcomes

  1. Rate of complications

    Time frame: Up to 2 years

    Transient or persistent hypoparathyroidism confirmed by serum calcium levels was less than the lower limit at examination center and had symptoms of hypocalcemia. Postoperative vocal cord paralysis was defined as fixed vocal cord mobility with laryngofiberoscopic examination.

  2. Scores of hospital anxiety and depression scale (HADS)

    Time frame: Up to 6 months

    All patients were requested to answer the HADS questionnaire, the scores of which were recorded.

  3. Scores of fear of progression questionnaire-short form(FPQS)

    Time frame: Up to 6 months

    All patients were requested to answer the FPQS questionnaire, the scores of which were recorded.

  4. Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire

    Time frame: Up to 6 months

    All patients were requested to answer the THYCA-QoL questionnaire, the scores of which were recorded.

  5. Rate of recurrence

    Time frame: 5-year estimate reported after a median follow-up of 60 months

    Lymph node recurrence or distant recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Qianqian Yuan, M.D.

CONTACT

[email protected]

13026322297

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Dec 14, 2020
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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