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

December 2, 2024 updated by: Ouyang Dian, Sun Yat-sen University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retro-Auricular Single-Site Endoscopic Thyroidectomy group
Patients in the retro-auricular single-site endoscopic thyroidectomy (RASSET) group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Procedure: Retro-Auricular Single-Site Endoscopic Thyroidectomy
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.
Active Comparator: Transoral Endoscopic Thyroidectomy Vestibular Approach group
Patients in the Transoral Endoscopic Thyroidectomy Vestibular Approach group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Procedure: Transoral Endoscopic Thyroidectomy Vestibular Approach
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.
Active Comparator: Transareola Endoscopic Thyroidectomy group
Patients in the Transareola Endoscopic Thyroidectomy group will receive endoscopic thyroid lobectomy and central lymph node dissection.
Procedure: Transareola Endoscopic Thyroidectomy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein，CRP
Time Frame: 1 week
the level of CRP before and after operation
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Amyloid A，SAA
Time Frame: 1 week
the level of CRP before and after operation
1 week
blood loss
Time Frame: 1 week
The volume of blood loss during operation
1 week
VAS pain score
Time Frame: 2 days after operation
Postoperative VAS score was recorded
2 days after operation
number of lymph nodes
Time Frame: 1 week after operation
Postoperative specimen Postoperative specimen Postoperative specimen Postoperative specimen the number of lymph nodes in postoperative specimens
1 week after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Dian Ouyang, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-359-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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