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

Bassem Mohamed Sieda1 site in 1 country199 target enrollmentNovember 2, 2016

ConditionsPapillary Thyroid Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Papillary Thyroid Carcinoma
Sponsor: Bassem Mohamed Sieda
Enrollment: 199
Locations: 1
Primary Endpoint: recurrence free survival
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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,

Registry

clinicaltrials.gov

Start Date

November 2, 2016

End Date

May 3, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bassem Mohamed Sieda

Responsible Party

Sponsor Investigator

Principal Investigator

Bassem Mohamed Sieda

Assistant Professor of general surgery, Faculty of medicine

Zagazig University

Eligibility Criteria

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