Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for PTC

September 29, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for Papillary Thyroid Carcinoma

Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120

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

Sampling Method

Non-Probability Sample

Study Population

The patients, who were diagnosed with papillary thyroid carcinoma at our center, chose to undergo either single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach or conventional open surgery.

Description

Inclusion Criteria:

  • (1) thyroid neoplasm <3.0 cm;
  • (2) well differentiated papillary thyroid carcinoma.

Exclusion Criteria:

  • (1) extrathyroidal extensions estimated in ultrasonography scan;
  • (2) enlarged lymph nodes in lateral neck compartment on palpation, or US scan;
  • (3) suspected distant metastases;
  • (4) previous history of neck radiation therapy and/or surgery.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the Subclavian Approach group
The patients chose to undergo total thyroidectomy and central compartment neck dissection via the single-incision subclavian approach.
Procedure: single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection
The included patients chose to undergo single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection via the subclavian approach based on patients preference.
the conventional open surgery group
The patients chose to undergo total thyroidectomy and central compartment neck dissection via the conventional open surgery approach.
Procedure: conventional open surgery
These patients chose to undergo total thyroidectomy with central compartment neck dissection via conventional open surgery based on patients preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the disease-free survival
Time Frame: up to 24 months
The disease-free survival refers to the probability of survival without any biologic, structural, or functional events.
up to 24 months

Collaborators and Investigators

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

September 20, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 29, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-1124-01

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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