Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

• ClinicalTrials.gov Identifier: NCT05446441
• Recruitment Status: Not yet recruiting
• First Posted: July 6, 2022
• Last Update Posted: July 6, 2022
• Sponsor: Zhejiang Provincial People's Hospital
• Information provided by (Responsible Party): Minghua Ge, Zhejiang Provincial People's Hospital

Tracking Information

• First Submitted Date: June 30, 2022
• First Posted Date: July 6, 2022
• Last Update Posted Date: July 6, 2022
• Estimated Study Start Date: June 28, 2022
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2022)

Number of retrieved central lymph nodes [ Time Frame: 1 month after operation ]

The number of central lymph nodes removed during the operation

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma
• Official Title: Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial
• Brief Summary: Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. This study is aimed to compare multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
• Detailed Description: Most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Endoscopic thyroidectomy using gasless unilateral transaxillary approach which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. Recently, endoscopic thyroidectomy using gasless unilateral transaxillary approach has been proven feasible and safe in several Chinese medical centers. In this study, we designed a prospective study comparing multi-institutional Chinese outcomes of endoscopic thyroidectomy using gasless unilateral transaxillary approach and conventional open surgery.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Single (Outcomes Assessor)

Primary Purpose: Treatment

• Condition: Thyroid Cancer

Intervention

Procedure: Endoscopic surgery;

Endoscopic thyroidectomy group is the papillary thyroid carcinoma patient group who underwent endoscopic thyroid surgery using a gasless, trans-axillary approach.

Study Arms

• Experimental: Intervention;
  Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.
  Intervention: Procedure: Endoscopic surgery;
• Active Comparator: Control
  Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.
  Intervention: Procedure: Endoscopic surgery;

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 30, 2022): 634
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age ≥ 18 years;
• The pathological type is papillary thyroid carcinoma;
• Tumor diameter <2 cm；
• No extraglandular invasion, or minimal extrathyroidal extension invading only anterior thyroid capsule or sternothyoid muscle；
• cN0 or cN+ without fusion and fixation of metastatic lymph nodes；
• no obvious contraindication for thyroidectomy ;
• Good comply with the research visit plan and other program requirements;
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• patients with severe systemic diseases who can not tolerate general anesthesia or routine surgical posture;
• previous history of neck surgery, radiotherapy or thermal ablation;
• hyperthyroidism and substernal goiter;
• dedifferentiated thyroid carcinoma；
• accompanied with severe thyroiditis.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Minghua Ge, Doctor; 86057187666666 ext 86057185335800; geminghua@hmc.edu.cn

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05446441
• Other Study ID Numbers: 2022（050）
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Minghua Ge, Zhejiang Provincial People's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhejiang Provincial People's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Minghua Ge, Doctor; Zhejiang Provincial People's Hospital

• PRS Account: Zhejiang Provincial People's Hospital
• Verification Date: June 2022