Papillary Thyroid CancerNCT06468696
Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
A study testing Suturing the cervical linea alba during endoscopic thyroid surgery. and Performing transcriptome sequencing in people with Papillary Thyroid Cancer and Lymph Node Metastasis, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Papillary Thyroid Cancer, Lymph Node Metastasis, Carcinogenesis
- What is being tested?
- Suturing the cervical linea alba during endoscopic thyroid surgery. and Performing transcriptome sequencing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Perform transthoracic endoscopic thyroidectomy via breast approach;
- Postoperative pathology confirms benign or malignant thyroid tumors;
- Preoperative thyroid ultrasound or cervical CT suggests no extrathyroidal invasion or distant metastasis of the tumor;
- No contraindications for general anesthesia;
- Patients with cosmetic requirements.
Who cannot join
- Underwent transthoracic endoscopic thyroidectomy;
- Postoperative pathology confirmed as benign or malignant thyroid tumors;
- Preoperative thyroid ultrasound or neck CT suggested no extraglandular invasion or distant metastasis of the tumor;
- No contraindications to general anesthesia;
- Patients with cosmetic demands.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, 710049
Zhidong Wang, Professor, +86 138 9182 3580, xawzd@163.com
About this study
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.
- Being tested
- Suturing the cervical linea alba during endoscopic thyroid surgery., Performing transcriptome sequencing
- Medical subject headings
- Thyroid Cancer, Papillary, Lymphatic Metastasis, Carcinogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing the cervical linea alba during endoscopic thyroid surgery.Procedure or surgery
Suturing the cervical linea alba during endoscopic thyroid surgery.
Performing transcriptome sequencingGenetic
Performing transcriptome sequencing
| Study group | Role | What they receive |
|---|---|---|
| Suturing the cervical linea alba during endoscopic thyroid surgery | Experimental | Suturing the cervical linea alba during endoscopic thyroid surgery. Receives: Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery. |
| Not suturing the cervical linea alba during endoscopic thyroid surgery | No intervention | Not suturing the cervical linea alba during endoscopic thyroid surgery. |
| Thyroid papillary carcinoma group | Other | Thyroid papillary carcinoma tissue. Receives: Genetic: Performing transcriptome sequencing |
| Thyroid papillary carcinoma adjacent group | Other | Thyroid papillary carcinoma adjacent tissue. Receives: Genetic: Performing transcriptome sequencing |
| Lymph node metastasis group | Other | Lymph node tissue with metastasis. Receives: Genetic: Performing transcriptome sequencing |
| Non-lymph node metastasis group | Other | Lymph node tissue without metastasis. Receives: Genetic: Performing transcriptome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative neck edema Incidence rate
Postoperative neck edema Incidence rate
Measured: Within one week post-surgery
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.
Measured: Within one week post-surgery
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.
Measured: Within one month after the transcriptome sequencing.
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.
Measured: Within one month after the transcriptome sequencing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Apr 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhidong Wang, Principal investigator, Xi'an Jiaotong University Second Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468696
- Sponsor's protocol ID
- 20230318
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Thyroid Tumor Surgery and the Prognosis, Diagnosis, Recurrence and Metastasis of Patients
- ClinicalTrials.gov ID
- NCT06468696
- Acronym / sponsor ID
- 20230318
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Suturing the cervical linea alba during endoscopic thyroid surgery | Experimental | Procedure: Suturing the cervical linea alba during endoscopic thyroid surgery.Suturing the cervical linea alba during endoscopic thyroid surgery. |
| Not suturing the cervical linea alba during endoscopic thyroid surgery | No intervention | –Not suturing the cervical linea alba during endoscopic thyroid surgery. |
| Thyroid papillary carcinoma group | Other | Genetic: Performing transcriptome sequencingThyroid papillary carcinoma tissue. |
| Thyroid papillary carcinoma adjacent group | Other | Genetic: Performing transcriptome sequencingThyroid papillary carcinoma adjacent tissue. |
| Lymph node metastasis group | Other | Genetic: Performing transcriptome sequencingLymph node tissue with metastasis. |
| Non-lymph node metastasis group | Other | Genetic: Performing transcriptome sequencingLymph node tissue without metastasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Perform transthoracic endoscopic thyroidectomy via breast approach;
- Postoperative pathology confirms benign or malignant thyroid tumors;
- Preoperative thyroid ultrasound or cervical CT suggests no extrathyroidal invasion or distant metastasis of the tumor;
- No contraindications for general anesthesia;
- Patients with cosmetic requirements.
Key exclusion criteria (5 listed)
- Underwent transthoracic endoscopic thyroidectomy;
- Postoperative pathology confirmed as benign or malignant thyroid tumors;
- Preoperative thyroid ultrasound or neck CT suggested no extraglandular invasion or distant metastasis of the tumor;
- No contraindications to general anesthesia;
- Patients with cosmetic demands.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suturing the cervical linea alba during endoscopic thyroid surgery.Suturing the cervical linea alba during endoscopic thyroid surgery. | Procedure or surgery | Suturing the cervical linea alba during endoscopic thyroid surgery |
| Performing transcriptome sequencingPerforming transcriptome sequencing | Genetic | Lymph node metastasis group, Non-lymph node metastasis group, Thyroid papillary carcinoma adjacent group, Thyroid papillary carcinoma group |
Primary outcome
Postoperative neck edema Incidence rate
Time frame: Within one week post-surgery
Postoperative neck edema Incidence rate
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhidong Wang principal investigator
Xi'an Jiaotong University Second Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing the cervical linea alba during endoscopic thyroid surgery. and Performing transcriptome sequencing in people with Papillary Thyroid Cancer and Lymph Node Metastasis, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhidong Wang, Professor (+86 138 9182 3580, xawzd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative neck edema Incidence rate (time frame: Within one week post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.