Thyroid DiseasesNCT05735054
A Novel Technique for Endoscopic Transaxillary Thyroidectomy Comparison
An observational study of Thyroid Diseases, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
The clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- endoscopic thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2024
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the patient who required thyroidectomy
Who may be able to join
- The patients with benign or malignant thyroid disease require lobe thyroidectomy;
- The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;
- Benign lesions with the largest diameter ≤5 cm;
- Differentiated thyroid cancer(DTC) meets the following conditions at the same time: ①The maximum diameter of the primary lesion is <2.5 cm; ②There is no extraglandular invasion or only minimal external invasion of the anterior thyroid capsule or minor invasion of the sternum thyroid muscle;
Who cannot join
- the patients had poor compliance and could not be reexamined regularly;
- There was a history of neck or thyroid surgery;
- The patients require total thyroidectomy or lateral neck dissection.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery , Second Affiliated Hospita l, Xi'an Jiaotong Universi ty School of Medicine
Xi'an, 710004
About this study
Official title: A Novel Technique for Endoscopic Transaxillary Thyroidectomy: a Preliminary Report and Comparison With the Open Procedure
The clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control.
- Conditions
- Thyroid Diseases
- Being tested
- endoscopic thyroidectomy
- Keywords
- endoscopy, thyroidectomy, transaxillary, open
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic thyroidectomyProcedure or surgery
the patients who underwent endoscopic transaxillary thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| endoscopic group | the patients who underwent endoscopic transaxillary thyroidectomy Receives: Procedure: endoscopic thyroidectomy | |
| open group | the patients who underwent open thyroidectomy Receives: Procedure: endoscopic thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time (OT)
The time will be reported as minutes.
Measured: during the operation
bleeding
intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.
Measured: during the operation
complications
any complications after operation
Measured: 6 moths after oepration
Secondary outcomes (3)
hospital stay
How many days will the patients stay in the hospital. The index will be reported as days.
Measured: 1 week
drainage days.
This index will record how many days does the drainage tube keep in the paitients. It will reported as days.
Measured: 1 week
drainage volume
This index will record the total volume from drainage tube after operation. It will reported as ml.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jan 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 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
- Yang Liu, Principal investigator, Xi'an Jiaotong University Second Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735054
- Sponsor's protocol ID
- 202303
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Wang J, Chen S, Lv H, Yu S, Ran X, Gao N, Sun Y, Cao G. Preliminary report on a novel technique for endoscopic transaxillary thyroidectomy: a case-control study. Int J Surg. 2024 Feb 1;110(2):654-659. doi: 10.1097/JS9.0000000000000885.
PubMed 37983762
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique for Endoscopic Transaxillary Thyroidectomy: a Preliminary Report and Comparison With the Open Procedure
- ClinicalTrials.gov ID
- NCT05735054
- Acronym / sponsor ID
- 202303
- Conditions
- Thyroid Diseases
- Keywords
- endoscopy, thyroidectomy, transaxillary, open
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Feb 2023 (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 clinical data from all except the first 20 cases who underwent our novel transaxillary thyroidectomy were collected retrospectively, while the data from patients who underwent conventional open thyroid lobectomy by same surgeon during the same period were used as a control.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic group | – | Procedure: endoscopic thyroidectomythe patients who underwent endoscopic transaxillary thyroidectomy |
| open group | – | Procedure: endoscopic thyroidectomythe patients who underwent open thyroidectomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the patient who required thyroidectomy
Key inclusion criteria (4 listed)
- The patients with benign or malignant thyroid disease require lobe thyroidectomy;
- The patient had cosmetic requirements and agreed with transaxillary thyroidectomy;
- Benign lesions with the largest diameter ≤5 cm;
- Differentiated thyroid cancer(DTC) meets the following conditions at the same time: ①The maximum diameter of the primary lesion is <2.5 cm; ②There is no extraglandular invasion or only minimal external invasion of the anterior thyroid capsule or minor invasion of the sternum thyroid muscle;
Key exclusion criteria (3 listed)
- the patients had poor compliance and could not be reexamined regularly;
- There was a history of neck or thyroid surgery;
- The patients require total thyroidectomy or lateral neck dissection.
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 thyroidectomythe patients who underwent endoscopic transaxillary thyroidectomy | Procedure or surgery | endoscopic group, open group |
Primary outcome
operation time (OT)
Time frame: during the operation
The time will be reported as minutes.
bleeding
Time frame: during the operation
intraoperatively bleeding volume. The intraoperative blood lose volume will be reported as ml.
complications
Time frame: 6 moths after oepration
any complications after operation
3 secondary outcomes
hospital stay
Time frame: 1 week
drainage days.
Time frame: 1 week
drainage volume
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 37983762Liu Y, Wang J, Chen S, Lv H, Yu S, Ran X, Gao N, Sun Y, Cao G. Preliminary report on a novel technique for endoscopic transaxillary thyroidectomy: a case-control study. Int J Surg. 2024 Feb 1;110(2):654-659. doi: 10.1097/JS9.0000000000000885.
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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.
Yang Liu 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?
An observational study of Thyroid Diseases, 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 4 inclusion and 3 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 28 Feb 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (OT) (time frame: during the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735054, which also lists 1 linked publication.
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 28 Feb 2023; AzTrials last refreshed its copy on 2 Nov 2026.