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A multicenter, randomized, controlled clinical study on the feasibility and safety of non-pneumatic transaxillary posterior approach endoscopic and open thyroidectomy for papillary thyroid cancer

A multicenter, randomized, controlled clinical study on the feasibility and safety of non-pneumatic transaxillary posterior approach endoscopic and open thyroidectomy for papillary thyroid cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053575
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Papillary thyroid carcinoma

Interventions

experimental group:Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
control group:Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection

Sponsors

Nanfang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patient's informed consent; 2. Aged > 18 years and < 70 years; 3. Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery; 4. Color Doppler TI-RADS 4c-5 of primary thyroid tumor; 5. The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging); 6. It is expected that R0 surgical results can be obtained by performing single thyroid lobectomy and isthmus resection + ipsilateral central lymph node dissection; 7. Preoperative ASA score I-III.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Suffering from serious mental illness; 3. Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes; 4. Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis; 5. Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function; 6. History of neck surgery; 7. History of thyroid surgery (including ablation therapy for thyroid nodules); 8. Family history of thyroid cancer; 9. History of childhood ionizing radiation exposure; 10. History of other malignant diseases within 5 years; 11. A history of unstable angina or myocardial infarction within 6 months; 12. History of cerebral infarction or cerebral hemorrhage within 6 months; 13. History of continuous systemic corticosteroid therapy within 1 month; 14. Concurrent surgical treatment of other diseases is required; 15. Patients who are judged by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Early complication rate;Life quality score;

Secondary

MeasureTime frame
The number of dissected lymph nodes;The volumn of residual gland;3-year recurrence rate;Operation duration;Blood loss;Hospital stays;Hospitalization expense;Inflammatory and immune response;

Countries

China

Contacts

Public ContactLei Shangtong

Nanfang Hospital of Southern Medical University

leisht781920@163.com+86 13632101395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026