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Application and influence of two different surgical methods in papillary thyroid carcinoma in the isthmus-prospective randomized controlled trial

Application and influence of two different surgical methods in papillary thyroid carcinoma in the isthmus-prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068406
Enrollment
Unknown
Registered
2023-02-17
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

papillary carcinoma of thyroid isthmus

Interventions

Experimental group:thyroid isthmus + bilateral intra-lobar 1/3 resection + bilateral central lymph node dissection
Control group:total thyroidectomy plus bilateral central lymph node dissection

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All PTCI patients aged 18-70 years old who were diagnosed or suspected by FNA cytology or histology before operation (confirmed by postoperative pathology as PTC) [in this study, the researchers drew two virtual lines perpendicular to the skin along the edges of the trachea, taking the intersection of the longest diameter and the shortest diameter of the lesion as the tumor center. If the tumor center of PTC is located between two dotted lines, it is considered to be PTCI. A virtual line perpendicular to the skin was drawn along the middle of the trachea, and the PTCI was divided into left PTCI (PTCIL), right PTCI (PTCIR) and median PTCI (PTCIC); 2. PTCI patients with tumor diameter <= 2cm (T1) and without any clinical evidence of lymph node metastasis (cN0); 3. Before entering the group, the results of laboratory examination were in accordance with the operation conditions, and there were no operative contraindications; 4. There are no psychological, family, social or geographical factors that may affect program compliance and follow-up time; 5. Voluntarily participate, sign informed consent, and be willing to follow up for a long time.

Exclusion criteria

Exclusion criteria: Patients with one of the following conditions may not be included in clinical trials: 1. Preoperative fine or thick needle puncture indicates non-PTC patients; 2. History of thyroid or parathyroid surgery, or other neck surgery; 3. History of radioactive iodine therapy; 4. History of external radiation in the neck; 5. Abnormal preoperative parathyroid hormone or serum calcium levels; 6. Dysfunction of liver, kidney, and other organs; 7. Pregnant and lactating women (excluded by routine urinary pregnancy test in female patients); 8. Those who cannot tolerate surgery for various reasons; 9. Those whose baseline data cannot be fully collected; 10. Other PTC patients who are not PTCI; 11. Those who are considered by researchers to be unsuitable for enrollment; 12. Subjects have poor compliance and are reluctant to participate.

Design outcomes

Primary

MeasureTime frame
Postoperative complication;Tumor recurrence rate;L-T4 dosage;Long-term quality of life;

Secondary

MeasureTime frame
Length of surgery;Number of lymph node dissection;Postoperative hospital stay;

Countries

China

Contacts

Public ContactAnping Su

West China Hospital, Sichuan University

suanpingping@126.com+86 158 8110 4970

Outcome results

None listed

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