Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients

Xi'an Jiaotong University

Status: Enrolling

Conditions: Lymph Node Metastasis; Papillary Thyroid Cancer; Carcinogenesis

Treatments: Genetic: Performing transcriptome sequencing; Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery.

Study type: Interventional

Funder types: Other

Identifiers

NCT06468696

20230318

Details and patient eligibility

About

The objective of this research is to investigate the clinical outcomes of modified surgical techniques such as omitting the cervical linea alba suture in transthoracic endoscopic thyroidectomy. Furthermore, the study requires the collection of normal thyroid tissues, benign and malignant thyroid tumors, and lymph nodes to further clarify the mechanisms associated with the initiation, progression, metastasis, and recurrence of thyroid cancer.

Full description

Study Purpose: Background and Significance Trans-axillary and trans-breast endoscopic thyroid surgery is currently the most widely used and recognized minimally invasive cosmetic thyroid surgery method. However, due to its inherent characteristics, this approach still has certain limitations that require further improvement. For example, there have been no studies reporting the short-term and long-term advantages of not suturing the cervical white line during trans-breast endoscopic thyroid surgery. Through theoretical analysis, it is suggested that not suturing the cervical white line during endoscopic thyroid surgery might be safe and feasible in terms of reducing operation time, postoperative pain, and incision complications, but this needs to be further verified.

The mechanisms underlying the occurrence, progression, metastasis, and recurrence of thyroid cancer are still not completely understood, necessitating further basic and clinically relevant research using clinical specimens.

Combining the current research progress domestically and internationally, the purpose of this study is to explore the clinical outcomes of improved surgical methods, such as not suturing the cervical white line during trans-axillary and trans-breast endoscopic thyroidectomy. In addition, the study aims to collect normal thyroid tissue, benign and malignant thyroid tumors, and lymph nodes to further elucidate the mechanisms related to the occurrence, progression, metastasis, and recurrence of thyroid cancer.

Study Procedure Before you are enrolled in the study, the doctor will conduct a detailed inquiry and record your medical history. Preoperative evaluations will include thyroid and lymph node ultrasound, neck CT, thyroid function tests, and fine-needle aspiration biopsy. If you meet the inclusion and exclusion criteria, you can voluntarily choose to participate in this study and sign an informed consent form. If you agree to participate in this study, you will be assigned a number, and a research file will be created.

This study will be conducted at the Second Affiliated Hospital of Xi'an Jiaotong University, with an estimated 200 voluntary participants. The research will involve collecting medical information data generated during routine clinical diagnosis and treatment, pathological reports, and tissue specimens from the thyroid, thyroid tumors, and lymph nodes obtained during surgery.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Perform transthoracic endoscopic thyroidectomy via breast approach;
2. Postoperative pathology confirms benign or malignant thyroid tumors;
3. Preoperative thyroid ultrasound or cervical CT suggests no extrathyroidal invasion or distant metastasis of the tumor;
4. No contraindications for general anesthesia;
5. Patients with cosmetic requirements.

Exclusion criteria

1. Underwent transthoracic endoscopic thyroidectomy;
2. Postoperative pathology confirmed as benign or malignant thyroid tumors;
3. Preoperative thyroid ultrasound or neck CT suggested no extraglandular invasion or distant metastasis of the tumor;
4. No contraindications to general anesthesia;
5. Patients with cosmetic demands.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 6 patient groups

Suturing the cervical linea alba during endoscopic thyroid surgery

Experimental group

Description:

Suturing the cervical linea alba during endoscopic thyroid surgery.

Treatment:

Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery.

Not suturing the cervical linea alba during endoscopic thyroid surgery

No Intervention group

Description:

Not suturing the cervical linea alba during endoscopic thyroid surgery.

Thyroid papillary carcinoma group

Other group

Description:

Thyroid papillary carcinoma tissue.

Treatment:

Genetic: Performing transcriptome sequencing

Thyroid papillary carcinoma adjacent group

Other group

Description:

Thyroid papillary carcinoma adjacent tissue.

Treatment:

Genetic: Performing transcriptome sequencing

Lymph node metastasis group

Other group

Description:

Lymph node tissue with metastasis.

Treatment:

Genetic: Performing transcriptome sequencing

Non-lymph node metastasis group

Other group

Description:

Lymph node tissue without metastasis.

Treatment:

Genetic: Performing transcriptome sequencing