Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

Launched by UNIVERSITY COLLEGE, LONDON · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best surgical approach for patients with low-risk differentiated thyroid cancer (DTC). Specifically, it compares two types of surgery: hemithyroidectomy (removing part of the thyroid) and total thyroidectomy (removing the entire thyroid). The goal is to see if hemithyroidectomy is just as effective and more cost-effective than total thyroidectomy for these patients. The trial will involve 456 participants who will be followed for several years after their surgery to check how well they do.

To be eligible for the trial, patients must be 16 years or older and diagnosed with low-risk DTC, either after having had some thyroid surgery already or through a biopsy that confirms the diagnosis. Participants will be randomly assigned to one of the two surgical options and will have regular check-ups after their surgery for six years. This study aims to help doctors better understand which surgical option may be more suitable for patients with low-risk thyroid cancer.

Gender

ALL

Eligibility criteria

• • Group 1 (HT already performed prior to diagnosis)
• • Inclusion criteria
• • • Aged 16 or over
• Papillary thyroid cancer:
• • pT1b-2 (≤4cm) irrespective of molecular genetic markers
• • R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local MDT)
• • cN0 or pN0, pNX \& pN1a (≤5 foci, no extranodal spread)
• • Confined to thyroid or minimal extrathyroidal extension
• • No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
• • No angioinvasion NB. PTC is still eligible where microscopic invasion of endothelial lined small capillary vascular spaces and lymphatic channels are present. It becomes ineligible in the rare instances when there is definite invasion of a larger vascular structure such as a vein with smooth muscle in its wall.
• • Encapsulated FVPTC with capsular invasion only
• • Micro-PTC (≤1cm)
• • multifocal
• • unifocal with pN1a (≤5 foci; no extranodal spread)
• Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:
• • pT1b-2 (≤4cm) irrespective of molecular genetic markers
• • - Minimally invasive, with capsular invasion +/- minimal (≤4 foci) vascular invasion (the latter is now called encapsulated angioinvasive and is at the discretion of the MDT)
• • Confined to thyroid or minimal extrathyroidal extension
• • Exclusion criteria
• • \>4cm
• • unifocal pT1a (≤1cm) PTC or FTC (unless pN1a as above)
• • NIFTP (non-invasive follicular thyroid neoplasm with papillary-like nuclear features)
• • Anaplastic, poorly differentiated or medullary thyroid carcinoma
• • R2
• • gross extrathyroidal extension
• • pT4 or macroscopic tumour invasion of loco-regional tissues or structures
• • pN1a with \>5 foci or extranodal spread
• • pN1b
• • M1
• * Aggressive PTC with any of the following features:
• • Widely invasive
• • Poorly differentiated
• • Anaplastic
• • predominance of Tall cell, Columnar cell, Hobnail, Diffuse sclerosing and other higher risk variants
• * FTC, including oncocytic or Hürthle cell cancer with any of the following features:
• • Minimally invasive with extensive vascular invasion (now called encapsulated angioinvasive) (\>4 foci)
• • Widely invasive
• • Poorly differentiated
• • Anaplastic
• • Group 2 (DTC on cytology or after core biopsy, who has not had prior thyroid surgery yet)
• • Inclusion criteria
• • Aged 16 or over
• • 'low risk' differentiated thyroid cancer confirmed by cytology or core biopsy.
• • cT1b-2 irrespective of molecular genetic markers
• • cN0
• • Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)
• • Exclusion criteria
• • • M1