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

Primary Purpose

Papillary Thyroid Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Retro-Auricular Single-Site Endoscopic Thyroidectomy

Transoral Endoscopic Thyroidectomy Vestibular Approach

Transareola Endoscopic Thyroidectomy

About this trial

This is an interventional treatment trial for Papillary Thyroid Carcinoma focused on measuring Papillary Thyroid Carcinoma Laparoscopy, Endoscopic Thyroidectomy, Retroauricular Single-site approach, Transoral Endoscopic Thyroidectomy Vestibular Approach, Transareola Endoscopic Thyroidectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Retro-Auricular Single-Site Endoscopic Thyroidectomy group

Transoral Endoscopic Thyroidectomy Vestibular Approach group

Transareola Endoscopic Thyroidectomy group

Arm Description

Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Outcomes

Primary Outcome Measures

C-reactive protein，CRP

the level of CRP before and after operation

Secondary Outcome Measures

Serum Amyloid A，SAA

the level of CRP before and after operation

blood loss

The volume of blood loss during operation

VAS pain score

Postoperative VAS score was recorded

number of lymph nodes

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

Full Information

NCT ID

NCT05760690

First Posted

February 13, 2023

Last Updated

April 11, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05760690

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2015 (Actual)

Primary Completion Date

June 28, 2023 (Anticipated)

Study Completion Date

June 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma Laparoscopy, Endoscopic Thyroidectomy, Retroauricular Single-site approach, Transoral Endoscopic Thyroidectomy Vestibular Approach, Transareola Endoscopic Thyroidectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Retro-Auricular Single-Site Endoscopic Thyroidectomy group

Arm Type

Experimental

Arm Description

Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Arm Title

Transoral Endoscopic Thyroidectomy Vestibular Approach group

Arm Type

Active Comparator

Arm Description

Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Arm Title

Transareola Endoscopic Thyroidectomy group

Arm Type

Active Comparator

Arm Description

Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.

Intervention Type

Procedure

Intervention Name(s)

Retro-Auricular Single-Site Endoscopic Thyroidectomy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transoral Endoscopic Thyroidectomy Vestibular Approach

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transareola Endoscopic Thyroidectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

C-reactive protein，CRP

Description

the level of CRP before and after operation

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Serum Amyloid A，SAA

Description

the level of CRP before and after operation

Time Frame

1 week

Title

blood loss

Description

The volume of blood loss during operation

Time Frame

1 week

Title

VAS pain score

Description

Postoperative VAS score was recorded

Time Frame

2 days after operation

Title

number of lymph nodes

Description

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

Time Frame

1 week after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dian Ouyang

Phone

+86-20-87343302

ouyd@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dian Ouyang

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Sun Yat-Sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dian Ouyang

Phone

+8615626278408

ouyd@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36753130

Citation

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.

Results Reference

background

PubMed Identifier

34743449

Citation

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.

Results Reference

background

PubMed Identifier

35205779

Citation

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.

Results Reference

background

PubMed Identifier

31346748

Citation

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.

Results Reference

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PubMed Identifier

11961613

Citation

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.

Results Reference

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PubMed Identifier

28877292

Citation

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.

Results Reference

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PubMed Identifier

30410996

Citation

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.

Results Reference

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PubMed Identifier

31531238

Citation

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.

Results Reference

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PubMed Identifier

31515625

Citation

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.

Results Reference

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

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