Clinical trial NCT04336696: Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Official title: Is Routine Dissection of Central Lymph Node Necessary for Papillary Thyroid Carcinoma, T1-2 N0?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Thyroid Carcinoma
Keywords: papillary carcinoma
recurrence of PTC
Radio-iodine therapy for PTC
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-04-07
Enrollment: 199
Sex: ALL
Minimum age (years): 42
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: prospective cohort study
Primary purpose: TREATMENT

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,

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

Primary outcomes:
measure: recurrence free survival
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
References:
citation: Viola D, Materazzi G, Valerio L, Molinaro E, Agate L, Faviana P, Seccia V, Sensi E, Romei C, Piaggi P, Torregrossa L, Sellari-Franceschini S, Basolo F, Vitti P, Elisei R, Miccoli P. Prophylactic central compartment lymph node dissection in papillary thyroid carcinoma: clinical implications derived from the first prospective randomized controlled single institution study. J Clin Endocrinol Metab. 2015 Apr;100(4):1316-24. doi: 10.1210/jc.2014-3825. Epub 2015 Jan 15.
citation: Kim K, Kim JH, Park IS, Rho YS, Kwon GH, Lee DJ. The Updated AJCC/TNM Staging System for Papillary Thyroid Cancer (8th Edition): From the Perspective of Genomic Analysis. World J Surg. 2018 Nov;42(11):3624-3631. doi: 10.1007/s00268-018-4662-2.