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Trial record 23 of 110 for:    CALCIUM CATION

Central Compartment Neck Dissection With Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106443
Recruitment Status : Terminated (Poor patient accrual)
First Posted : April 19, 2010
Last Update Posted : December 14, 2016
Information provided by (Responsible Party):
Peter Dziegielewski, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Indeterminate Thyroid Nodules Procedure: Total Thyroidectomy + CLND Procedure: Total thyroidectomy - CLND Procedure: Hemi-thyroidectomy + CLND Procedure: Hemi-thyroidectomy - CLND Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Central Compartment Neck Dissection Total Thyroidectomy: a Randomized Controlled Trial
Study Start Date : February 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Active Comparator: Total Thyroidectomy - CLND
Total thyroidectomy without central lymph node dissection.
Procedure: Total thyroidectomy - CLND
Removal of all possible thyroid tissue without dissection of neck level 6.

Experimental: Total Thyroidectomy +CLND
Total thyroidectomy with central lymph node dissection.
Procedure: 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.

Experimental: Hemi-thyroidectomy + CLND
Hemi-thyroidectomy with central lymph node dissection.
Procedure: Hemi-thyroidectomy + CLND
Removal of one thyroid lobe and ipsilateral central lymph nodes

Active Comparator: Hemi-thyroidectomy - CLND
Hemi-thyroidectomy without central lymph node dissection.
Procedure: Hemi-thyroidectomy - CLND
Removal of one thyroid lobe only. No lymphatic dissection.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Long Term Hypocalcemia [ Time Frame: > 1month ]
    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

  2. Vocal Cord Dysfunction [ Time Frame: 1 month post-operatively ]

    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)

  3. Positive Nodes [ Time Frame: At the time of operation. (Time 0) ]
    Presence of disease with in central lymph node dissection as per pathology report.

  4. Surgical Time [ Time Frame: During the operation. (Time 0) ]
    Time from cutting skin to putting on last steri-strip on closed incision in the operating theatre.

  5. Length of Hospital Stay [ Time Frame: 1 day post-operatively on average ]
    Days spent in the hospital post-operatively.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106443

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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2B6
Canada, Nova Scotia
Dalhouise University
Halifax, Nova Scotia, Canada, B3H3A7
Sponsors and Collaborators
University of Alberta
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Study Director: Peter T Dziegielewski, MD University of Alberta
Principal Investigator: Jeffrey R Harris, MD, FRCSC University of Alberta
Study Chair: Robert Hart, MD, FRCSC Dalhousie University
Study Chair: Elaine Fung, MD Dalhousie University

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Responsible Party: Peter Dziegielewski, MD, FRCSC, University of Alberta Identifier: NCT01106443     History of Changes
Other Study ID Numbers: 88888
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by Peter Dziegielewski, University of Alberta:
Indeterminate thyroid nodule
fine needle aspirate biopsy
central lymph node dissection
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms