ClinicalTrials.Veeva

Menu

Central Compartment Neck Dissection With Thyroidectomy

U

University of Alberta

Status

Terminated

Conditions

Indeterminate Thyroid Nodules

Treatments

Procedure: Hemi-thyroidectomy + CLND
Procedure: Hemi-thyroidectomy - CLND
Procedure: Total thyroidectomy - CLND
Procedure: Total Thyroidectomy + CLND

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

When a patient presents with a thyroid mass, part of the work-up may include a fine needle aspiration biopsy (FNAB). The results of the biopsy then help plan treatment. If the results are benign, the management will typically be to follow the nodule. If the results demonstrate or are suspicious for cancer, such as papillary thyroid carcinoma (PTC), the treatment is a total thyroidectomy (total thyroid removal). The latest American thyroid association guidelines for PTC (2009) suggest that in many instances a central lymph node dissection (CLND) should be performed in conjunction with the total thyroidectomy. This procedure consists of removing the lymphatic (glandular) tissues surrounding the thyroid itself, as this tissue may have a propensity for cancer spread. The procedure's necessity has met much controversy in the last decade, but is becoming more of a standard in thyroid cancer surgery.

When a thyroid nodule FNAB is reported as indeterminate, the treatment strategy is less clear cut. While a diagnostic hemi-thyroidectomy or therapeutic total thyroidectomy may be in order, the inclusion of CLND is not clearly defined. In many centers a CLND will be omitted with surgical management for an "indeterminate" lesion, while in others, it is standard protocol. The argument of performing CLND is largely based on the tenet that it adds little surgical time, cost or risks to the patient. Because the evidence of the prognostic role of lymph node metastases is limited many would argue that the risk of not performing CLND is greater than performing CLND. Furthermore, in the event of finding cancer on final pathology, and thus, having to re-operate in the thyroid/central compartment bed, post-operative complications may increase. Opponents of CLND argue that there is a paucity of strong evidence supporting CLND in the improvement of oncologic outcomes and can potentially increase post-operative low calcium levels or vocal nerve damage However, these recommendations are based on retrospective level III evidence. Thus the debate continues: is CLND justified as an adjunct to hemi-or total thyroidectomy in indeterminate thyroid pathology?

The hypothesis is: CLND in hem- or total thyroidectomy for "indeterminate" thyroid nodules will not increase post-operative complications.

Enrollment

128 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Indeterminate or benign pathology on fine needle aspirate biopsy
  • Scheduled to undergo total or hemi-thyroidectomy
  • > 18 years old

Exclusion criteria

  • Previous thyroid surgery
  • Previous neck surgery in field of thyroidectomy
  • Previous neck irradiation
  • Pre-operative hypocalcemia or hypoparathyroidism
  • Biopsy suggestive of thyroid cancer
  • Neck nodes suspicious for or with known cancer
  • Pre-operative vocal cord dysfunction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 4 patient groups

Total Thyroidectomy - CLND
Active Comparator group
Description:
Total thyroidectomy without central lymph node dissection.
Treatment:
Procedure: Total thyroidectomy - CLND
Total Thyroidectomy +CLND
Experimental group
Description:
Total thyroidectomy with central lymph node dissection.
Treatment:
Procedure: Total Thyroidectomy + CLND
Hemi-thyroidectomy + CLND
Experimental group
Description:
Hemi-thyroidectomy with central lymph node dissection.
Treatment:
Procedure: Hemi-thyroidectomy + CLND
Hemi-thyroidectomy - CLND
Active Comparator group
Description:
Hemi-thyroidectomy without central lymph node dissection.
Treatment:
Procedure: Hemi-thyroidectomy - CLND

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems