Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?

Not Applicable

• Conditions: Papillary Thyroid Carcinoma
• Interventions: Procedure: Total thyroidectomy and central neck dissection

• Registration Number: NCT04336696
• Lead Sponsor: Bassem Mohamed Sieda

Brief Summary

study assigned into three groups, Group I was the control group operated by total thyroidectomy and retrospectively followed, where the other two groups Operated by Total thyroidectomy and central neck dissection. Recurrence Free Survival (RFS) was the main issue of the study and calculated as the time from date of surgery to date of relapse or the most recent follow-up contact that patient was known as relapse-free, Study exclusively studied the outcome and advantage of central neck dissection

Detailed Description

informed consent taken, study was a prospective cohort study, with controlled group a retrospectively. patients ablated by total thyroidectomy only who failed to achieve ablation with the first dose of iodine 131I may be dynamically risk stratified as high-risk category and managed aggressively. N0 patients will benefit and ablated by total thyroidectomy and prophylactic central neck dissection, PCND decreases the residual, increase the RFS and patients without residual do not need adjuvant RAI therapy except in high risk group. Histological grading, size of the primary tumour, the extension of PTC, the extent of surgery were found to be a strong predicting factor for recurrence-free survival

Locoregional recurrence cases always found more in male patients aged more than 45 years old. Size of the primary tumour and the extent of surgery was a significant factor for RFS,

Study Timeline

• Study Start: 2016-11-02
• Status Verified: 2020-04
• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-02
• Last Update Submitted: 2020-04-02
• Primary Completion: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Study Completion: 2020-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0)

Exclusion Criteria

• Younger age ≤20 years. Prior thyroidectomy, previous radiation exposure, postoperative radioactive iodine therapy, Histopathology report of any type of malignancy other than PTC or patients did not complete their postoperative follow-up period. PTC With N1 or N2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Comparison between the studied groups regarding management.	Total thyroidectomy and central neck dissection	The postoperative RAI scan after 1 month, showed a positive residual tumour in lateral LN in 70 patients in the controlled group and 13 patients in Group II, 8 patients in group III. In group I, Patients with residuals were submitted to RAI ablation.
Recurrence free survival	Total thyroidectomy and central neck dissection	patients with total thyroidectomy only had shorter recurrence free survival

Primary Outcome Measures

Name	Time	Method
recurrence free survival	21 months	recurrence free survival calculated from first day of diagnosis

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt