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

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

NCT ID: NCT06468696

Condition: Papillary Thyroid Cancer
Lymph Node Metastasis
Carcinogenesis

Conditions: Official terms:
Neoplasm Metastasis
Thyroid Neoplasms
Lymphatic Metastasis
Thyroid Cancer, Papillary
Carcinogenesis
Thyroid Diseases
Recurrence

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Suturing the cervical linea alba during endoscopic thyroid surgery.
Description: Suturing the cervical linea alba during endoscopic thyroid surgery.
Arm group label: Suturing the cervical linea alba during endoscopic thyroid surgery

Intervention type: Genetic
Intervention name: Performing transcriptome sequencing
Description: Performing transcriptome sequencing
Arm group label: Lymph node metastasis group
Arm group label: Non-lymph node metastasis group
Arm group label: Thyroid papillary carcinoma adjacent group
Arm group label: Thyroid papillary carcinoma group

Summary: 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.

Detailed 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Xi'an Jiaotong University Second Affiliated Hospital

Address:
City: Xi'an
Zip: 710049
Country: China

Status: Recruiting

Contact:
Last name: Zhidong Wang, Professor

Phone: +86 138 9182 3580
Email: xawzd@163.com

Start date: April 1, 2023

Completion date: January 1, 2026

Lead sponsor:
Agency: Second Affiliated Hospital of Xi'an Jiaotong University
Agency class: Other

Source: Second Affiliated Hospital of Xi'an Jiaotong University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06468696