| Registry | NCT06468696 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 170 (Estimated) |
| Sponsor | Second Affiliated Hospital of Xi'an Jiaotong University (Other) |
| Conditions | Papillary Thyroid Cancer, Lymph Node Metastasis, Carcinogenesis |
| Interventions | Suturing the cervical linea alba during endoscopic thyroid surgery., Performing transcriptome sequencing (Procedure, genetic) |
| Dates | start 2023-04-01, primary completion 2026-01-01 (estimated), completion 2026-01-01 (estimated), first posted 2024-06-21, last updated 2024-06-21 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Papillary Thyroid Cancer All trials for Lymph Node Metastasis All trials of Suturing the cervical linea alba during endoscopic thyroid surgery. All trials of Performing transcriptome sequencing
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Suturing the cervical linea alba during endoscopic thyroid surgery | Experimental | Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery. | Suturing the cervical linea alba during endoscopic thyroid surgery. |
| Not suturing the cervical linea alba during endoscopic thyroid surgery | No intervention | Not suturing the cervical linea alba during endoscopic thyroid surgery. | |
| Thyroid papillary carcinoma group | Other | Genetic: Performing transcriptome sequencing | Thyroid papillary carcinoma tissue. |
| Thyroid papillary carcinoma adjacent group | Other | Genetic: Performing transcriptome sequencing | Thyroid papillary carcinoma adjacent tissue. |
| Lymph node metastasis group | Other | Genetic: Performing transcriptome sequencing | Lymph node tissue with metastasis. |
| Non-lymph node metastasis group | Other | Genetic: Performing transcriptome sequencing | Lymph node tissue without metastasis. |
Sex: All, ages: 18 Years to 75 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Xi'an Jiaotong University Second Affiliated Hospital | Xi'an, Shaanxi | China | Recruiting |