Clinical trial NCT06468696: Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
Official title: Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Papillary Thyroid Cancer
Lymph Node Metastasis
Carcinogenesis
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Postoperative neck edema Incidence rate
timeFrame: Within one week post-surgery
measure: Postoperative short-term pain
timeFrame: Within one week post-surgery
measure: Thyroid Papillary carcinoma tissue mRNA expression profile
timeFrame: Within one month after the transcriptome sequencing.
measure: Thyroid papillary carcinoma metastatic lymph node mRNA expression profile
timeFrame: Within one month after the transcriptome sequencing.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University Second Affiliated Hospital
state: Shaanxi
Study officials:
affiliation: Xi'an Jiaotong University Second Affiliated Hospital
name: Zhidong Wang
role: PRINCIPAL_INVESTIGATOR
References: