Study Results
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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TERMINATED
NA
128 participants
INTERVENTIONAL
2010-02-28
2016-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Total Thyroidectomy - CLND
Total thyroidectomy without central lymph node dissection.
Total thyroidectomy - CLND
Removal of all possible thyroid tissue without dissection of neck level 6.
Total Thyroidectomy +CLND
Total thyroidectomy with central lymph node dissection.
Total Thyroidectomy + CLND
Total thyroidectomy includes removing all possible thyroid tissue. Central lymph node dissection is a neck level 6 dissection. This includes removal of all central lymphatics from carotid artery to carotid artery and hyoid to sternum/clavicle.
Hemi-thyroidectomy + CLND
Hemi-thyroidectomy with central lymph node dissection.
Hemi-thyroidectomy + CLND
Removal of one thyroid lobe and ipsilateral central lymph nodes
Hemi-thyroidectomy - CLND
Hemi-thyroidectomy without central lymph node dissection.
Hemi-thyroidectomy - CLND
Removal of one thyroid lobe only. No lymphatic dissection.
Interventions
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Total Thyroidectomy + CLND
Total thyroidectomy includes removing all possible thyroid tissue. Central lymph node dissection is a neck level 6 dissection. This includes removal of all central lymphatics from carotid artery to carotid artery and hyoid to sternum/clavicle.
Total thyroidectomy - CLND
Removal of all possible thyroid tissue without dissection of neck level 6.
Hemi-thyroidectomy + CLND
Removal of one thyroid lobe and ipsilateral central lymph nodes
Hemi-thyroidectomy - CLND
Removal of one thyroid lobe only. No lymphatic dissection.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo total or hemi-thyroidectomy
* \> 18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Peter Dziegielewski
MD, FRCSC
Principal Investigators
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Peter T Dziegielewski, MD
Role: STUDY_DIRECTOR
University of Alberta
Jeffrey R Harris, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Robert Hart, MD, FRCSC
Role: STUDY_CHAIR
Dalhousie University
Elaine Fung, MD
Role: STUDY_CHAIR
Dalhousie University
Locations
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University of Alberta
Edmonton, Alberta, Canada
Dalhouise University
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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88888
Identifier Type: -
Identifier Source: org_study_id