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

June 20, 2024 updated by: Second Affiliated Hospital of Xi'an Jiaotong University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhidong Wang, Professor
  • Phone Number: +86 138 9182 3580
  • Email: xawzd@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710049
        • Recruiting
        • Xi'an Jiaotong University Second Affiliated Hospital
        • Contact:
          • Zhidong Wang, Professor
          • Phone Number: +86 138 9182 3580
          • Email: xawzd@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suturing the cervical linea alba during endoscopic thyroid surgery
Suturing the cervical linea alba during endoscopic thyroid surgery.
Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery.
Suturing the cervical linea alba during endoscopic thyroid surgery.
No Intervention: Not suturing the cervical linea alba during endoscopic thyroid surgery
Not suturing the cervical linea alba during endoscopic thyroid surgery.
Other: Thyroid papillary carcinoma group
Thyroid papillary carcinoma tissue.
Genetic: Performing transcriptome sequencing
Performing transcriptome sequencing
Other: Thyroid papillary carcinoma adjacent group
Thyroid papillary carcinoma adjacent tissue.
Genetic: Performing transcriptome sequencing
Performing transcriptome sequencing
Other: Lymph node metastasis group
Lymph node tissue with metastasis.
Genetic: Performing transcriptome sequencing
Performing transcriptome sequencing
Other: Non-lymph node metastasis group
Lymph node tissue without metastasis.
Genetic: Performing transcriptome sequencing
Performing transcriptome sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative neck edema Incidence rate
Time Frame: Within one week post-surgery
Postoperative neck edema Incidence rate
Within one week post-surgery
Postoperative short-term pain
Time Frame: Within one week post-surgery
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
Thyroid Papillary carcinoma tissue mRNA expression profile
Time Frame: Within one month after the transcriptome sequencing.
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.
Thyroid papillary carcinoma metastatic lymph node mRNA expression profile
Time Frame: Within one month after the transcriptome sequencing.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Zhidong Wang, Xi'an Jiaotong University Second Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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