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

NCT06592755 | Recruiting

• 1 other identifier: SYSKY-2023-1124-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papillary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• the disease-free survival

  The disease-free survival refers to the probability of survival without any biologic, structural, or functional events.

  up to 24 months

Study Arms (2)

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 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

Interventions

single-incision, gasless endoscopic total thyroidectomy with central compartment neck dissection PROCEDURE

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 Subclavian Approach group

conventional open surgery PROCEDURE

These patients chose to undergo total thyroidectomy with central compartment neck dissection via conventional open surgery based on patients preference.

the conventional open surgery group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Lin

CONTACT

0086-020-34071439; linpliang3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)