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Endoscopic Thyroidectomy Versus Open Thyroidectomy for Papillary Thyroid Carcinoma

Endoscopic Thyroidectomy Using Gasless Unilateral Transaxillary Approach Versus Conventional Open Thyroidectomy for Papillary Thyroid Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05446441
Enrollment
634
Registered
2022-07-06
Start date
2022-06-28
Completion date
2025-08-31
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer

Keywords

Thyroid Cancer, Endoscopic surgery, Open surgery, Radical thyroidectomy

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.

Interventions

PROCEDUREEndoscopic surgery;

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

Sponsors

Zhejiang Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of retrieved central lymph nodes1 month after operationThe number of central lymph nodes removed during the operation

Contacts

Primary ContactMinghua Ge, Doctor
geminghua@hmc.edu.cn86057187666666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026