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

Papillary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468696
• Other study ID #: 20230318
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2024
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Zhidong Wang, Professor
• Phone: +86 138 9182 3580
• Email: xawzd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinogenesis
• Lymph Node Metastasis
• Lymphatic Metastasis
• Neoplasm Metastasis
• Papillary Thyroid Cancer
• Recurrence
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Genetic:
• Performing transcriptome sequencing
Performing transcriptome sequencing

Locations

Country	Name	City	State
China	Xi'an Jiaotong University Second Affiliated Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative neck edema Incidence rate	Postoperative neck edema Incidence rate	Within one week post-surgery
Primary	Postoperative short-term pain	Record the patient's perception of wound pain on postoperative days 1, 3, and 5 using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain), for quantification.	Within one week post-surgery
Primary	Thyroid Papillary carcinoma tissue mRNA expression profile	After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data.	Within one month after the transcriptome sequencing.
Primary	Thyroid papillary carcinoma metastatic lymph node mRNA expression profile	After extracting total RNA from tissue, it is purified and a cDNA library is constructed. Following library quality control, sequencing is conducted on the Illumina NovaSeq 6000 platform using the PE150 mode to obtain tissue mRNA expression data.	Within one month after the transcriptome sequencing.