Indeterminate Thyroid NodulesNCT01106443
Central Compartment Neck Dissection With Thyroidectomy
A study testing Total Thyroidectomy + CLND, Total thyroidectomy - CLND and Hemi-thyroidectomy + CLND in people with Indeterminate Thyroid Nodules, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indeterminate Thyroid Nodules
- What is being tested?
- Total Thyroidectomy + CLND, Total thyroidectomy - CLND and Hemi-thyroidectomy + CLND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2010to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indeterminate or benign pathology on fine needle aspirate biopsy
- Scheduled to undergo total or hemi-thyroidectomy
- > 18 years old
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G2B6
Dalhouise University
Halifax, Nova Scotia, B3H3A7
About this study
Official title: Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
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.
- Conditions
- Indeterminate Thyroid Nodules
- Being tested
- Total Thyroidectomy + CLND, Total thyroidectomy - CLND, Hemi-thyroidectomy + CLND, Hemi-thyroidectomy - CLND
- Keywords
- Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Thyroidectomy + CLNDProcedure or surgery
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 - CLNDProcedure or surgery
Removal of all possible thyroid tissue without dissection of neck level 6.
Hemi-thyroidectomy + CLNDProcedure or surgery
Removal of one thyroid lobe and ipsilateral central lymph nodes
Hemi-thyroidectomy - CLNDProcedure or surgery
Removal of one thyroid lobe only. No lymphatic dissection.
| Study group | Role | What they receive |
|---|---|---|
| Total Thyroidectomy - CLND | Active comparator | Total thyroidectomy without central lymph node dissection. Receives: Procedure: Total thyroidectomy - CLND |
| Total Thyroidectomy +CLND | Experimental | Total thyroidectomy with central lymph node dissection. Receives: Procedure: Total Thyroidectomy + CLND |
| Hemi-thyroidectomy + CLND | Experimental | Hemi-thyroidectomy with central lymph node dissection. Receives: Procedure: Hemi-thyroidectomy + CLND |
| Hemi-thyroidectomy - CLND | Active comparator | Hemi-thyroidectomy without central lymph node dissection. Receives: Procedure: Hemi-thyroidectomy - CLND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: < 1 month post-operatively
Secondary outcomes (5)
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
Measured: > 1month
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)
Measured: 1 month post-operatively
Positive Nodes
Presence of disease with in central lymph node dissection as per pathology report.
Measured: At the time of operation. (Time 0)
Surgical Time
Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.
Measured: During the operation. (Time 0)
Length of Hospital Stay
Days spent in the hospital post-operatively.
Measured: 1 day post-operatively on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2013
- Study completionOct 2016
Why it stopped: Poor patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indeterminate Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Dziegielewski, University of Alberta
- Investigators
- Peter T Dziegielewski, MD, Study director, University of AlbertaJeffrey R Harris, MD, FRCSC, Principal investigator, University of AlbertaRobert Hart, MD, FRCSC, Study chair, Dalhousie UniversityElaine Fung, MD, Study chair, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106443
- Sponsor's protocol ID
- 88888
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2010
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01106443
- Acronym / sponsor ID
- 88888
- Conditions
- Indeterminate Thyroid Nodules
- Keywords
- Indeterminate thyroid nodule, fine needle aspirate biopsy, thyroidectomy, central lymph node dissection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient accrual
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total Thyroidectomy - CLND | Active comparator | Procedure: Total thyroidectomy - CLNDTotal thyroidectomy without central lymph node dissection. |
| Total Thyroidectomy +CLND | Experimental | Procedure: Total Thyroidectomy + CLNDTotal thyroidectomy with central lymph node dissection. |
| Hemi-thyroidectomy + CLND | Experimental | Procedure: Hemi-thyroidectomy + CLNDHemi-thyroidectomy with central lymph node dissection. |
| Hemi-thyroidectomy - CLND | Active comparator | Procedure: Hemi-thyroidectomy - CLNDHemi-thyroidectomy without central lymph node dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indeterminate or benign pathology on fine needle aspirate biopsy
- Scheduled to undergo total or hemi-thyroidectomy
- > 18 years old
Key exclusion criteria (7 listed)
- Previous thyroid surgery
- Previous neck surgery in field of thyroidectomy
- Previous neck irradiation
- Pre-operative hypocalcemia or hypoparathyroidism
- Biopsy suggestive of thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Thyroidectomy + CLNDTotal 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. | Procedure or surgery | Total Thyroidectomy +CLND |
| Total thyroidectomy - CLNDRemoval of all possible thyroid tissue without dissection of neck level 6. | Procedure or surgery | Total Thyroidectomy - CLND |
| Hemi-thyroidectomy + CLNDRemoval of one thyroid lobe and ipsilateral central lymph nodes | Procedure or surgery | Hemi-thyroidectomy + CLND |
| Hemi-thyroidectomy - CLNDRemoval of one thyroid lobe only. No lymphatic dissection. | Procedure or surgery | Hemi-thyroidectomy - CLND |
Primary outcome
Short Term Hypo-calcemia
Time frame: < 1 month post-operatively
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
5 secondary outcomes
Long Term Hypocalcemia
Time frame: > 1month
Vocal Cord Dysfunction
Time frame: 1 month post-operatively
Positive Nodes
Time frame: At the time of operation. (Time 0)
Surgical Time
Time frame: During the operation. (Time 0)
Length of Hospital Stay
Time frame: 1 day post-operatively on average
Results and safety
The study was stopped early (reason given: Poor patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter T Dziegielewski, MD study director
University of Alberta
Jeffrey R Harris, MD, FRCSC principal investigator
University of Alberta
Robert Hart, MD, FRCSC study chair
Dalhousie University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Thyroidectomy + CLND, Total thyroidectomy - CLND and Hemi-thyroidectomy + CLND in people with Indeterminate Thyroid Nodules, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor patient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Term Hypo-calcemia (time frame: < 1 month post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.