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

Study Overview
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Brief Summary
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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
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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,

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

Conditions
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Papillary Thyroid Carcinoma

Intervention / Treatment
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* Procedure: Total thyroidectomy and central neck dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: prospective cohort study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparison between the studied groups regarding management.<br>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. | Procedure: Total thyroidectomy and central neck dissection<br> <br> |
| Other: Recurrence free survival<br>patients with total thyroidectomy only had shorter recurrence free survival | Procedure: Total thyroidectomy and central neck dissection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence free survival | recurrence free survival calculated from first day of diagnosis | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC