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

NCT ID: NCT06468696

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Papillary Thyroid Cancer Lymph Node Metastasis Carcinogenesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suturing the cervical linea alba during endoscopic thyroid surgery

Suturing the cervical linea alba during endoscopic thyroid surgery.

Group Type EXPERIMENTAL

Suturing the cervical linea alba during endoscopic thyroid surgery.

Intervention Type PROCEDURE

Suturing the cervical linea alba during endoscopic thyroid surgery.

Not suturing the cervical linea alba during endoscopic thyroid surgery

Not suturing the cervical linea alba during endoscopic thyroid surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Thyroid papillary carcinoma group

Thyroid papillary carcinoma tissue.

Group Type OTHER

Performing transcriptome sequencing

Intervention Type GENETIC

Performing transcriptome sequencing

Thyroid papillary carcinoma adjacent group

Thyroid papillary carcinoma adjacent tissue.

Group Type OTHER

Performing transcriptome sequencing

Intervention Type GENETIC

Performing transcriptome sequencing

Lymph node metastasis group

Lymph node tissue with metastasis.

Group Type OTHER

Performing transcriptome sequencing

Intervention Type GENETIC

Performing transcriptome sequencing

Non-lymph node metastasis group

Lymph node tissue without metastasis.

Group Type OTHER

Performing transcriptome sequencing

Intervention Type GENETIC

Performing transcriptome sequencing

Interventions

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Suturing the cervical linea alba during endoscopic thyroid surgery.

Suturing the cervical linea alba during endoscopic thyroid surgery.

Intervention Type PROCEDURE

Performing transcriptome sequencing

Performing transcriptome sequencing

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhidong Wang

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University Second Affiliated Hospital

Locations

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Xi'an Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhidong Wang, Professor

Role: CONTACT

+86 138 9182 3580

Facility Contacts

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Zhidong Wang, Professor

Role: primary

+86 138 9182 3580

Other Identifiers

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20230318

Identifier Type: -

Identifier Source: org_study_id

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