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RecruitingNCT06468696Updated Jun 21, 2024

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

An interventional study of Suturing the cervical linea alba during endoscopic thyroid surgery. and Performing transcriptome sequencing in Papillary Thyroid Cancer, Lymph Node Metastasis and Carcinogenesis, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2023, registered Jun 2024).
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 170 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 68 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • 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.

  • 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

  • Other
    Thyroid papillary carcinoma adjacent group

    Thyroid papillary carcinoma adjacent tissue.

    Genetic: Performing transcriptome sequencing

  • Other
    Lymph node metastasis group

    Lymph node tissue with metastasis.

    Genetic: Performing transcriptome sequencing

  • Other
    Non-lymph node metastasis group

    Lymph node tissue without metastasis.

    Genetic: Performing transcriptome sequencing

Interventions

  • ProcedureSuturing the cervical linea alba during endoscopic thyroid surgery.

    Suturing the cervical linea alba during endoscopic thyroid surgery.

  • GeneticPerforming transcriptome sequencing

    Performing transcriptome sequencing

06

What researchers measure

Primary outcomes

  1. Postoperative neck edema Incidence rate

    Postoperative neck edema Incidence rate

    Time frame: Within one week post-surgery

  2. 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.

    Time frame: Within one week post-surgery

  3. 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.

    Time frame: Within one month after the transcriptome sequencing.

  4. 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.

    Time frame: Within one month after the transcriptome sequencing.

07

Study locations

1 of 1 sites recruiting
  • Xi'an Jiaotong University Second Affiliated Hospital
    Xi'an, Shaanxi 710049, China
    • Zhidong Wang, Professor · Contact · xawzd@163.com · +86 138 9182 3580
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06468696
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Apr 1, 2023
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Jun 21, 2024

Study contacts

Zhidong Wang, Professor
Contact
xawzd@163.com
+86 138 9182 3580
Zhidong Wang
principal investigator · Xi'an Jiaotong University Second Affiliated Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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