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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-02

Study Completion Date

2020-05-03

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

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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,

Conditions

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Papillary Thyroid Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

guuartor of study, only participant

Study Groups

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Comparison between the studied groups regarding management.

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.

Group Type ACTIVE_COMPARATOR

Total thyroidectomy and central neck dissection

Intervention Type PROCEDURE

Recurrence free survival

patients with total thyroidectomy only had shorter recurrence free survival

Group Type OTHER

Total thyroidectomy and central neck dissection

Intervention Type PROCEDURE

Interventions

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Total thyroidectomy and central neck dissection

Intervention Type PROCEDURE

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

Minimum Eligible Age

42 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes