Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Single (Outcomes Assessor)

Study Groups

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Intervention;

Endoscopic thyroidectomy was performed in a standardized fashion by multi-institutional Chinese experienced surgeons using the same gasless unilateral transaxillary approach.

Group Type EXPERIMENTAL

Endoscopic surgery;

Intervention Type PROCEDURE

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

Control

Conventional open surgery was performed in a standardized fashion by multi-institutional Chinese experienced surgeons.

Group Type ACTIVE_COMPARATOR

Endoscopic surgery;

Intervention Type PROCEDURE

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

Interventions

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Endoscopic surgery;

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No