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A multicenter, prospective, randomized controlled trial of the efficacy and safety of gasless transaxillary endoscopic versus conventional open surgery for cN0,, unilateral and low-risk papillary thyroid carcinoma

A multicenter, prospective, randomized controlled trial of the efficacy and safety of gasless transaxillary endoscopic versus conventional open surgery for cN0,, unilateral and low-risk papillary thyroid carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058627
Enrollment
Unknown
Registered
2022-04-12
Start date
2022-04-20
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

papillary thyroid carcinoma

Interventions

Endoscopic group:Endoscopic thyroidectomy
Open surgery group:Open thyroidectomy

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years, = 60 years; 2. Preoperative cytology showed papillary thyroid carcinoma; 3. Single cancer nodule, limited in the thyroid gland, without capsule invasion, with a diameter of<4 cm; 4. No imaging central area and lateral neck lymph node metastasis (cN0); 5. Body mass index (BMI) is 18.5-24 kg/m2; 6. The patient requested surgical treatment, voluntarily participated in this study, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Obvious extraglandular invasion of the tumor, such as recurrent laryngeal nerve, larynx, trachea, esophagus, etc; 2. Complicated with hyperthyroidism, thyroiditis or severe Hashimoto thyroiditis; 3. The tumor is located in the thyroid isthmus; 4. Previous neck surgery, ablation therapy or neck radiation history; 5. Those with severe comorbidities who cannot tolerate general anesthesia or conventional surgical posture; 6. Complicated with malignant tumors in other parts or previous treatment history of malignant tumors; 7. Primary parathyroid diseases such as parathyroid adenoma or parathyroid cyst with abnormal parathyroid function; 8. Cervical and thoracic malformations and clavicular malformations; 9. Patients refuse to operate or participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Number of retrieved lymph nodes;Number of metastatic lymph nodes;Weight of central neck dissection;Recurrence rate;metastasis rate;survival rate;

Secondary

MeasureTime frame
clinicopathological characteristics;surgical time;Blood loss;Drainage;Postoperative hospital stay;pain score;Complications;Injury of important structures;postoperative voice;inflammatory factor;Swallowing function;Quality of Life;

Countries

China

Contacts

Public ContactLi Chao

Sichuan Cancer Hospital

headneck@qq.com+86 28 85420166

Outcome results

None listed

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