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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04336696
Enrollment
199
Registered
2020-04-07
Start date
2016-11-02
Completion date
2020-05-03
Last updated
2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Carcinoma

Keywords

papillary carcinoma, recurrence of PTC, Radio-iodine therapy for PTC

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,

Interventions

PROCEDURETotal thyroidectomy and central neck dissection

Sponsors

Bassem Mohamed Sieda
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

guuartor of study, only participant

Intervention model description

prospective cohort study

Eligibility

Sex/Gender
ALL
Age
42 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
recurrence free survival21 monthsrecurrence free survival calculated from first day of diagnosis

Countries

Egypt

Contacts

Primary ContactBassem M Sieda
drbassemmostafa@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026