AzTrials
AzTrials

Papillary Thyroid CarcinomaNCT05760690

Safety of Endoscopic Thyroidectomy Via Retro-Auricular Single-Site Approach, Transoral Approach and Transareola

A study testing Retro-Auricular Single-Site Endoscopic Thyroidectomy, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy in people with Papillary Thyroid Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Papillary Thyroid Carcinoma
What is being tested?
Retro-Auricular Single-Site Endoscopic Thyroidectomy, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Jan 2015to 1 Dec 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years old, no gender restrictions.
  • Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
  • Early stage PTC (stage T1N0M0).
  • Preoperative ultrasonography showed unilateral glandular lobe malignant tumor and the largest diameter was not more than 2cm, without cervical lymph node metastasis and extensive metastasis.
  • Patients undergoing thyroid lobectomy and central lymph node dissection.
  • Patients who have signed an approved Informed Consent.

Who cannot join

  • Patients who do not accept case data collection for various reasons.
  • The clinical data unfit this study (at the discretion of the investigator).
  • Patients who have undergone neck surgery or radiotherapy before this trail.
  • Patients who have uncontrolled hyperthyroidism.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Single-center, Retrospective Study of Retro-Auricular Single-Site Endoscopic, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy in Patients With Early Stage Papillary Thyroid Carcinoma

The goal of this retrospective study is to compare the safety and efficiacy of endoscopic thyroidectomy via retro-auricular single-site approach, transoral endoscopic thyroidectomy vestibular approach and transareola approach.

Being tested
Retro-Auricular Single-Site Endoscopic Thyroidectomy, Transoral Endoscopic Thyroidectomy Vestibular Approach, Transareola Endoscopic Thyroidectomy
Keywords
Papillary Thyroid Carcinoma Laparoscopy, Endoscopic Thyroidectomy, Retroauricular Single-site approach, Transoral Endoscopic Thyroidectomy Vestibular Approach, Transareola Endoscopic Thyroidectomy
Medical subject headings
Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retro-Auricular Single-Site Endoscopic ThyroidectomyProcedure or surgery

    The strap muscles and the sternocleidomastoid muscle were separated. Upper parathyroid and lower parathyroid glands were identified and preserved. The recurrent laryngeal nerve (RLN) was identified，A lobe of thyroid specimen and central lymph nodes were dissected.

  • Transoral Endoscopic Thyroidectomy Vestibular ApproachProcedure or surgery

    The patient was placed in a supine position with slight neck extension under nasotracheal intubation. The mouth was garbled with povidone iodine before surgery. Three laparoscopic ports (a 10- to 15-mm port at midline and two 5-mm ports at the lateral junction between the canine and first premolar teeth)were inserted under the lower lip at the oral vestibular area.The strap muscleswere separated in the midline to expose the thyroid and trachea. The recurrent laryngeal nerve (RLN) was identified at the insertion to the larynx, then followed downandparallel tothe trachea inferiorly.

  • Transareola Endoscopic ThyroidectomyProcedure or surgery

    The patient was in supine position. Incision was made inside the right areola and a 10mm puncture device was placed, subcutaneous separation rod was used to separate the space, and a 30° endoscope was introduced, puncture device was placed in a 5mm incision on the left areola, ultrasonic knife free flap was used, subcutaneous separation space was placed in the upper sternal segment, and a 5mm puncture device was placed outside the right areola. The anterior cervical flap was further dissociated to establish a space. The median cervical line was cut to cut off the isthmus of the thyroid, and the tracheal fascia ligament of the thyroid was separated and the nerve was exposed to protect the nerves. Then remove the lobe of thyroid and central lymph nodes

Study groups in NCT05760690
Study groupRoleWhat they receive
Retro-Auricular Single-Site Endoscopic Thyroidectomy groupExperimentalPatients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Receives: Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy
Transoral Endoscopic Thyroidectomy Vestibular Approach groupActive comparatorPatients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Receives: Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach
Transareola Endoscopic Thyroidectomy groupActive comparatorPatients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Receives: Procedure: Transareola Endoscopic Thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-reactive protein，CRP

    the level of CRP before and after operation

    Measured: 1 week

Secondary outcomes (4)

  1. Serum Amyloid A，SAA

    the level of CRP before and after operation

    Measured: 1 week

  2. blood loss

    The volume of blood loss during operation

    Measured: 1 week

  3. VAS pain score

    Postoperative VAS score was recorded

    Measured: 2 days after operation

  4. number of lymph nodes

    Postoperative specimen Postoperative specimen Postoperative specimen Postoperative specimen the number of lymph nodes in postoperative specimens

    Measured: 1 week after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start1 Jan 2015
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Resources

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
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05760690
Sponsor's protocol ID
B2022-359-01
Status last verified
Dec 2024
First submitted
13 Feb 2023
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dong F, Yang A, Ouyang D. Retroauricular Single-Site Endoscopic Thyroidectomy-A Balanced Endoscopic Approach for Thyroid Excision. JAMA Surg. 2023 May 1;158(5):548-549. doi: 10.1001/jamasurg.2022.7723.

    PubMed 36753130

  • Dong F, Ao Y, Li MT, Zhan ZR, Lin YQ, Tan QJ, Li H, Yang AK, Ouyang D. [A comparative study between retro-auricular single-site endoscopic thyroidectomy and transoral endoscopic thyroidectomy vestibular approach: a single-center retrospective analysis]. Zhonghua Wai Ke Za Zhi. 2021 Nov 1;59(11):891-896. doi: 10.3760/cma.j.cn112139-20210903-00420. Chinese.

    PubMed 34743449

  • Liang TJ, Chen IS, Liu SI. Working Space Creation in Transoral Thyroidectomy: Pearls and Pitfalls. Cancers (Basel). 2022 Feb 17;14(4):1031. doi: 10.3390/cancers14041031.

    PubMed 35205779

  • Sun H, Zheng H, Wang X, Zeng Q, Wang P, Wang Y. Comparison of transoral endoscopic thyroidectomy vestibular approach, total endoscopic thyroidectomy via areola approach, and conventional open thyroidectomy: a retrospective analysis of safety, trauma, and feasibility of central neck dissection in the treatment of papillary thyroid carcinoma. Surg Endosc. 2020 Jan;34(1):268-274. doi: 10.1007/s00464-019-06762-6. Epub 2019 Jul 25.

    PubMed 31346748

  • Ikeda Y, Takami H, Niimi M, Kan S, Sasaki Y, Takayama J. Endoscopic thyroidectomy and parathyroidectomy by the axillary approach. A preliminary report. Surg Endosc. 2002 Jan;16(1):92-5. doi: 10.1007/s004640080175. Epub 2001 Nov 12.

    PubMed 11961613

  • Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.

    PubMed 28877292

  • Russell JO, Razavi CR, Al Khadem MG, Lopez M, Saraf S, Prescott JD, Starmer HM, Richmon JD, Tufano RP. Anterior cervical incision-sparing thyroidectomy: Comparing retroauricular and transoral approaches. Laryngoscope Investig Otolaryngol. 2018 Sep 24;3(5):409-414. doi: 10.1002/lio2.200. eCollection 2018 Oct.

    PubMed 30410996

  • Sephton BM. Extracervical Approaches to Thyroid Surgery: Evolution and Review. Minim Invasive Surg. 2019 Aug 20;2019:5961690. doi: 10.1155/2019/5961690. eCollection 2019.

    PubMed 31531238

  • Lee DW, Ko SH, Song CM, Ji YB, Kim JK, Tae K. Comparison of postoperative cosmesis in transaxillary, postauricular facelift, and conventional transcervical thyroidectomy. Surg Endosc. 2020 Aug;34(8):3388-3397. doi: 10.1007/s00464-019-07113-1. Epub 2019 Sep 12.

    PubMed 31515625

Questions about this trial

What is this clinical trial studying?

A study testing Retro-Auricular Single-Site Endoscopic Thyroidectomy, Transoral Endoscopic Thyroidectomy Vestibular Approach and Transareola Endoscopic Thyroidectomy in people with Papillary Thyroid Carcinoma, run by Sun Yat-sen 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 3 Dec 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

C-reactive protein，CRP (time frame: 1 week). 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 NCT05760690, which also lists 9 linked publications.

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 3 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in