Thyroid CancerNCT05446441
Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma
A study testing Endoscopic surgery; in people with Thyroid Cancer, run by Zhejiang Provincial People's Hospital.
Trial summary
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Endoscopic surgery;
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2022to 31 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- The pathological type is papillary thyroid carcinoma;
- Tumor diameter <2 cm；
- No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
- cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
- no obvious contraindication for thyroidectomy ;
- Good comply with the research visit plan and other program requirements;
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
- previous history of neck surgery, radiotherapy or thermal ablation;
- hyperthyroidism and substernal goiter;
- dedifferentiated thyroid carcinoma；
- accompanied with severe thyroiditis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
Read the detailed description
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
- Conditions
- Thyroid Cancer
- Being tested
- Endoscopic surgery;
- Keywords
- Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic surgery;Procedure or surgery
Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.
| Study group | Role | What they receive |
|---|---|---|
| Intervention; | Experimental | Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach. Receives: Procedure: Endoscopic surgery; |
| Control | Active comparator | Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons. Receives: Procedure: Endoscopic surgery; |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved central lymph nodes
The number of central lymph nodes removed during the operation
Measured: 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start28 Jun 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minghua Ge, Zhejiang Provincial People's Hospital
- Investigators
- Minghua Ge, Doctor, Principal investigator, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446441
- Sponsor's protocol ID
- 2022（050）
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05446441
- Acronym / sponsor ID
- 2022（050）
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 28 Jun 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Jul 2022 (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.
Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
Detailed description
Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention; | Experimental | Procedure: Endoscopic surgery;Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach. |
| Control | Active comparator | Procedure: Endoscopic surgery;Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- The pathological type is papillary thyroid carcinoma;
- Tumor diameter <2 cm；
- No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
- cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
Key exclusion criteria (5 listed)
- patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
- previous history of neck surgery, radiotherapy or thermal ablation;
- hyperthyroidism and substernal goiter;
- dedifferentiated thyroid carcinoma；
- accompanied with severe thyroiditis.
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 |
|---|---|---|
| Endoscopic surgery;Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach. | Procedure or surgery | Control, Intervention; |
Primary outcome
Number of retrieved central lymph nodes
Time frame: 1 month after operation
The number of central lymph nodes removed during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Minghua Ge, Doctor principal investigator
Zhejiang Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic surgery; in people with Thyroid Cancer, run by Zhejiang Provincial People's Hospital.
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 8 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Minghua Ge, Doctor (86057187666666 ext. 86057185335800, geminghua@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved central lymph nodes (time frame: 1 month after operation). 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 6 Jul 2022.