Central Compartment Neck Dissection With Thyroidectomy
Primary Purpose
Indeterminate Thyroid Nodules
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Total Thyroidectomy + CLND
Total thyroidectomy - CLND
Hemi-thyroidectomy + CLND
Hemi-thyroidectomy - CLND
Sponsored by
About this trial
This is an interventional treatment trial for Indeterminate Thyroid Nodules focused on measuring Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection
Eligibility Criteria
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
Sites / Locations
- University of Alberta
- Dalhouise University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
Total Thyroidectomy - CLND
Total Thyroidectomy +CLND
Hemi-thyroidectomy + CLND
Hemi-thyroidectomy - CLND
Arm Description
Total thyroidectomy without central lymph node dissection.
Total thyroidectomy with central lymph node dissection.
Hemi-thyroidectomy with central lymph node dissection.
Hemi-thyroidectomy without central lymph node dissection.
Outcomes
Primary Outcome Measures
Short Term Hypo-calcemia
Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbness, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
Secondary Outcome Measures
Long Term Hypocalcemia
Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbness, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
Vocal Cord Dysfunction
A surrogate for recurrent laryngeal nerve function. Determined pre- and post-operatively via flexible naso-pharyngoscopy (standard of care).
- evaluated by a validated measure (Voice Handicap Index)
Positive Nodes
Presence of disease with in central lymph node dissection as per pathology report.
Surgical Time
Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.
Length of Hospital Stay
Days spent in the hospital post-operatively.
Full Information
NCT ID
NCT01106443
First Posted
April 14, 2010
Last Updated
December 13, 2016
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01106443
Brief Title
Central Compartment Neck Dissection With Thyroidectomy
Official Title
Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor patient accrual
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indeterminate Thyroid Nodules
Keywords
Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Thyroidectomy - CLND
Arm Type
Active Comparator
Arm Description
Total thyroidectomy without central lymph node dissection.
Arm Title
Total Thyroidectomy +CLND
Arm Type
Experimental
Arm Description
Total thyroidectomy with central lymph node dissection.
Arm Title
Hemi-thyroidectomy + CLND
Arm Type
Experimental
Arm Description
Hemi-thyroidectomy with central lymph node dissection.
Arm Title
Hemi-thyroidectomy - CLND
Arm Type
Active Comparator
Arm Description
Hemi-thyroidectomy without central lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
Total Thyroidectomy + CLND
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy - CLND
Intervention Description
Removal of all possible thyroid tissue without dissection of neck level 6.
Intervention Type
Procedure
Intervention Name(s)
Hemi-thyroidectomy + CLND
Intervention Description
Removal of one thyroid lobe and ipsilateral central lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Hemi-thyroidectomy - CLND
Intervention Description
Removal of one thyroid lobe only. No lymphatic dissection.
Primary Outcome Measure Information:
Title
Short Term Hypo-calcemia
Description
Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbness, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
Time Frame
< 1 month post-operatively
Secondary Outcome Measure Information:
Title
Long Term Hypocalcemia
Description
Definition: Serum Ionized Calcium (ICa) < 0.9 mmol/L or symptoms related to hypocalcemia (acral or peri-oral paresthesia/numbness, tetany, muscle cramps/twitching, delirium etc.) and ICa < 1.0 mmol/L
Time Frame
> 1month
Title
Vocal Cord Dysfunction
Description
A surrogate for recurrent laryngeal nerve function. Determined pre- and post-operatively via flexible naso-pharyngoscopy (standard of care).
- evaluated by a validated measure (Voice Handicap Index)
Time Frame
1 month post-operatively
Title
Positive Nodes
Description
Presence of disease with in central lymph node dissection as per pathology report.
Time Frame
At the time of operation. (Time 0)
Title
Surgical Time
Description
Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.
Time Frame
During the operation. (Time 0)
Title
Length of Hospital Stay
Description
Days spent in the hospital post-operatively.
Time Frame
1 day post-operatively on average
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Dziegielewski, MD
Organizational Affiliation
University of Alberta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeffrey R Harris, MD, FRCSC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Hart, MD, FRCSC
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elaine Fung, MD
Organizational Affiliation
Dalhousie University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B6
Country
Canada
Facility Name
Dalhouise University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
12. IPD Sharing Statement
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Central Compartment Neck Dissection With Thyroidectomy
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