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Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

Primary Purpose

Papillary Thyroid Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
retro-auricular single-site endoscopic thyroidectomy
traditional open surgery thyroidectomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18-70 years old, no gender restrictions.
  2. Fine-needle aspiration cytology(FNA) confirmed papillary thyroid carcinoma(PTC).
  3. Early stage PTC (stage T1N0M0).
  4. 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.
  5. Patients undergoing thyroid lobectomy and central lymph node dissection.
  6. Patients who have signed an approved Informed Consent.

Exclusion Criteria:

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

Sites / Locations

  • Sun Yat-Sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RASSET group

traditional open thyroid lobectomy 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 traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Intra-operative, peri-operative, post-operative clinicopathologic characteristics
Baseline clinicopathologic characteristics of patients
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).

Full Information

First Posted
February 20, 2022
Last Updated
April 17, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05263141
Brief Title
Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

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, Thyroidectomy, Laparoscopy, Retroauricular approach, Single-site

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RASSET 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
traditional open thyroid lobectomy group
Arm Type
Active Comparator
Arm Description
Patients in the traditional open thyroid lobectomy group will receive thyroid lobectomy and central lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
retro-auricular single-site endoscopic thyroidectomy
Other Intervention Name(s)
RASSET
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)
traditional open surgery thyroidectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative cosmetic satisfaction scores
Description
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).
Time Frame
3 months from surgery
Secondary Outcome Measure Information:
Title
postoperative Vancouver Scar Scale
Description
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.
Time Frame
3 months from surgery
Title
postoperative Vancouver Scar Scale
Description
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.
Time Frame
1 month from surgery
Title
Intra-operative, peri-operative, post-operative clinicopathologic characteristics
Description
Baseline clinicopathologic characteristics of patients
Time Frame
1 week from surgery
Title
postoperative cosmetic satisfaction scores
Description
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).
Time Frame
1 month from surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dian Ouyang
Phone
+86-20-87343302
Email
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
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dian Ouyang
Phone
+86-20-87343302
Email
ouyd@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28877292
Citation
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Results Reference
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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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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
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PubMed Identifier
18297357
Citation
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Results Reference
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PubMed Identifier
26858014
Citation
Berber 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.
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PubMed Identifier
32706603
Citation
Nguyen 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.
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Retro-Auricular Single-Site Endoscopic to Papillary Thyroid Carcinoma

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