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

Papillary Thyroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336696
• Other study ID #: 0000-0002-9836-9580
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: May 3, 2020

Study information

• Verified date: April 2020
• Source: Zagazig University
• Contact: Bassem M Sieda
• Email: drbassemmostafa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 199
• Est. completion date: May 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Total thyroidectomy and central neck dissection

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Bassem Mohamed Sieda

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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 thyro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence free survival	recurrence free survival calculated from first day of diagnosis	21 months