Papillary Thyroid CarcinomaNCT05263141
Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma
A study testing retro-auricular single-site endoscopic thyroidectomy and traditional open surgery thyroidectomy in people with Papillary Thyroid Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection. 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 and traditional open surgery thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Nov 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.
About this study
Official title: Single-center, Prospective, Non-Randomized Control Clinical Trial of Retro-Auricular Single-Site Endoscopic Versus Open Surgery in Patients With Early Stage Papillary Thyroid Carcinoma
The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.
- Conditions
- Papillary Thyroid Carcinoma
- Being tested
- retro-auricular single-site endoscopic thyroidectomy, traditional open surgery thyroidectomy
- Keywords
- Papillary Thyroid Carcinoma, Thyroidectomy, Laparoscopy, Retroauricular approach, Single-site
- 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
Also called RASSET
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.
traditional open surgery thyroidectomyProcedure or surgery
The strap muscles were separated in the midline to expose the thyroid gland. 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.
| Study group | Role | What they receive |
|---|---|---|
| RASSET group | Experimental | Patients 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 |
| traditional open thyroid lobectomy group | Active comparator | Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection. Receives: Procedure: traditional open surgery thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cosmetic satisfaction scores
The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction).
Measured: 3 months from surgery
Secondary outcomes (4)
postoperative Vancouver Scar Scale
The Vancouver Scar Scale(VSS) is used for scar assessment. It has six domains: vascularity, pigmentation, pliability, height, pain and itchiness. The maximum score for the sum of the domain scores is 18, which corresponds to the worst scar, while 0 indicates normal skin.
Measured: 3 months from surgery
postoperative Vancouver Scar Scale
The Vancouver Scar Scale(VSS) is used for scar assessment. It has six domains: vascularity, pigmentation, pliability, height, pain and itchiness. The maximum score for the sum of the domain scores is 18, which corresponds to the worst scar, while 0 indicates normal skin.
Measured: 1 month from surgery
Intra-operative, peri-operative, post-operative clinicopathologic characteristics
Baseline clinicopathologic characteristics of patients
Measured: 1 week from surgery
postoperative cosmetic satisfaction scores
The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction).
Measured: 1 month from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ouyang Dian, Sun Yat-sen University
- Investigators
- Dian Ouyang, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263141
- Sponsor's protocol ID
- B2022-012-02
- Status last verified
- Dec 2024
- First submitted
- 20 Feb 2022
- 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
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 28877292Lee 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 31515625Dong 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 34743449Schardey HM, Schopf S, Kammal M, Barone M, Rudert W, Hernandez-Richter T, Portl S. Invisible scar endoscopic thyroidectomy by the dorsal approach: experimental development of a new technique with human cadavers and preliminary clinical results. Surg Endosc. 2008 Apr;22(4):813-20. doi: 10.1007/s00464-008-9761-y. Epub 2008 Feb 23.
PubMed 18297357Berber E, Bernet V, Fahey TJ 3rd, Kebebew E, Shaha A, Stack BC Jr, Stang M, Steward DL, Terris DJ; American Thyroid Association Surgical Affairs Committee. American Thyroid Association Statement on Remote-Access Thyroid Surgery. Thyroid. 2016 Mar;26(3):331-7. doi: 10.1089/thy.2015.0407.
PubMed 26858014Russell 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 30410996Nguyen HX, Nguyen HX, Nguyen HV, Nguyen LT, Nguyen TTP, Le QV. Transoral Endoscopic Thyroidectomy by Vestibular Approach with Central Lymph Node Dissection for Thyroid Microcarcinoma. J Laparoendosc Adv Surg Tech A. 2021 Apr;31(4):410-415. doi: 10.1089/lap.2020.0411. Epub 2020 Jul 17.
PubMed 32706603Nakajo A, Arima H, Hirata M, Mizoguchi T, Kijima Y, Mori S, Ishigami S, Ueno S, Yoshinaka H, Natsugoe S. Trans-Oral Video-Assisted Neck Surgery (TOVANS). A new transoral technique of endoscopic thyroidectomy with gasless premandible approach. Surg Endosc. 2013 Apr;27(4):1105-10. doi: 10.1007/s00464-012-2588-6. Epub 2012 Nov 21.
PubMed 23179070Duek I, Duek OS, Fliss DM. Minimally Invasive Approaches for Thyroid Surgery-Pitfalls and Promises. Curr Oncol Rep. 2020 Jun 29;22(8):77. doi: 10.1007/s11912-020-00939-2.
PubMed 32601931Chung EJ, Park MW, Cho JG, Baek SK, Kwon SY, Woo JS, Jung KY. A prospective 1-year comparative study of endoscopic thyroidectomy via a retroauricular approach versus conventional open thyroidectomy at a single institution. Ann Surg Oncol. 2015 Sep;22(9):3014-21. doi: 10.1245/s10434-014-4361-7. Epub 2015 Jan 21.
PubMed 25605517Schardey HM, Barone M, Portl S, von Ahnen M, von Ahnen T, Schopf S. Invisible scar endoscopic dorsal approach thyroidectomy: a clinical feasibility study. World J Surg. 2010 Dec;34(12):2997-3006. doi: 10.1007/s00268-010-0769-9.
PubMed 20835708
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Prospective, Non-Randomized Control Clinical Trial of Retro-Auricular Single-Site Endoscopic Versus Open Surgery in Patients With Early Stage Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05263141
- Acronym / sponsor ID
- B2022-012-02
- Conditions
- Papillary Thyroid Carcinoma
- Keywords
- Papillary Thyroid Carcinoma, Thyroidectomy, Laparoscopy, Retroauricular approach, Single-site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 2 Mar 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.
The goal of this non randomized control clinical research study is to compare the cosmetic outcomes and efficiacy of retro-auricular single-site endoscopic thyroid lobectomy and central lymph node dissection against conventional resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RASSET group | Experimental | Procedure: retro-auricular single-site endoscopic thyroidectomyPatients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection. |
| traditional open thyroid lobectomy group | Active comparator | Procedure: traditional open surgery thyroidectomyPatients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| retro-auricular single-site endoscopic thyroidectomyAlso: RASSETThe 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. | Procedure or surgery | RASSET group |
| traditional open surgery thyroidectomyThe strap muscles were separated in the midline to expose the thyroid gland. 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. | Procedure or surgery | traditional open thyroid lobectomy group |
Primary outcome
postoperative cosmetic satisfaction scores
Time frame: 3 months from surgery
The cosmetic satisfaction score(CSS) was defined as the sum of the scores on questions about the scar. Q1 and Q2 was using a verbal response scale from 1 to 5 (corresponding to decreasing satisfaction). The other four questions, each on a scale of 0 to 3 (again of decreasing satisfaction).
4 secondary outcomes
postoperative Vancouver Scar Scale
Time frame: 3 months from surgery
postoperative Vancouver Scar Scale
Time frame: 1 month from surgery
Intra-operative, peri-operative, post-operative clinicopathologic characteristics
Time frame: 1 week from surgery
postoperative cosmetic satisfaction scores
Time frame: 1 month from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 28877292Anuwong 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.
- Background: PubMed 31515625Lee 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.
- Background: PubMed 34743449Dong 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.
- Background: PubMed 18297357Schardey HM, Schopf S, Kammal M, Barone M, Rudert W, Hernandez-Richter T, Portl S. Invisible scar endoscopic thyroidectomy by the dorsal approach: experimental development of a new technique with human cadavers and preliminary clinical results. Surg Endosc. 2008 Apr;22(4):813-20. doi: 10.1007/s00464-008-9761-y. Epub 2008 Feb 23.
- Background: PubMed 26858014Berber E, Bernet V, Fahey TJ 3rd, Kebebew E, Shaha A, Stack BC Jr, Stang M, Steward DL, Terris DJ; American Thyroid Association Surgical Affairs Committee. American Thyroid Association Statement on Remote-Access Thyroid Surgery. Thyroid. 2016 Mar;26(3):331-7. doi: 10.1089/thy.2015.0407.
- Background: PubMed 30410996Russell 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.
- Background: PubMed 32706603Nguyen HX, Nguyen HX, Nguyen HV, Nguyen LT, Nguyen TTP, Le QV. Transoral Endoscopic Thyroidectomy by Vestibular Approach with Central Lymph Node Dissection for Thyroid Microcarcinoma. J Laparoendosc Adv Surg Tech A. 2021 Apr;31(4):410-415. doi: 10.1089/lap.2020.0411. Epub 2020 Jul 17.
- Background: PubMed 23179070Nakajo A, Arima H, Hirata M, Mizoguchi T, Kijima Y, Mori S, Ishigami S, Ueno S, Yoshinaka H, Natsugoe S. Trans-Oral Video-Assisted Neck Surgery (TOVANS). A new transoral technique of endoscopic thyroidectomy with gasless premandible approach. Surg Endosc. 2013 Apr;27(4):1105-10. doi: 10.1007/s00464-012-2588-6. Epub 2012 Nov 21.
- Background: PubMed 32601931Duek I, Duek OS, Fliss DM. Minimally Invasive Approaches for Thyroid Surgery-Pitfalls and Promises. Curr Oncol Rep. 2020 Jun 29;22(8):77. doi: 10.1007/s11912-020-00939-2.
- Background: PubMed 25605517Chung EJ, Park MW, Cho JG, Baek SK, Kwon SY, Woo JS, Jung KY. A prospective 1-year comparative study of endoscopic thyroidectomy via a retroauricular approach versus conventional open thyroidectomy at a single institution. Ann Surg Oncol. 2015 Sep;22(9):3014-21. doi: 10.1245/s10434-014-4361-7. Epub 2015 Jan 21.
- Background: PubMed 20835708Schardey HM, Barone M, Portl S, von Ahnen M, von Ahnen T, Schopf S. Invisible scar endoscopic dorsal approach thyroidectomy: a clinical feasibility study. World J Surg. 2010 Dec;34(12):2997-3006. doi: 10.1007/s00268-010-0769-9.
- 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.
Dian Ouyang study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retro-auricular single-site endoscopic thyroidectomy and traditional open surgery 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?
postoperative cosmetic satisfaction scores (time frame: 3 months from surgery). 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 NCT05263141, which also lists 11 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.