Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-06

Study Completion Date

2020-10-26

Brief Summary

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This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.

Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the rate of transient and permanent hypocalcemia

SECONDARY OBJECTIVES:

I. To determine the rate of voice and swallowing problems.

II. To determine the degree to which quality of life (QOL) is compromised.

III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques.

IV. To determine clinical recurrence rates.

OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.

Arm I: Patients undergo total thyroidectomy alone.

Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).

Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up.

After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.

Conditions

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Stage I Papillary Thyroid Cancer Stage II Papillary Thyroid Cancer Stage III Papillary Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (no CND)

Patients undergo total thyroidectomy alone.

Group Type EXPERIMENTAL

Thyroidectomy

Intervention Type PROCEDURE

Undergo total thyroidectomy

Quality-of-life assessment

Intervention Type OTHER

Voice evaluation, interviews, ancillary studies

Arm II (CND)

Patients undergo total thyroidectomy with ipsilateral prophylactic CND.

Group Type EXPERIMENTAL

Thyroidectomy

Intervention Type PROCEDURE

Undergo total thyroidectomy

entral lymph node dissection (CLND)

Intervention Type PROCEDURE

Undergo total thyroidectomy with ipsilateral prophylactic CND

Quality-of-life assessment

Intervention Type OTHER

Voice evaluation, interviews, ancillary studies

Arm III (SOC)

Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference

Group Type ACTIVE_COMPARATOR

Quality-of-life assessment

Intervention Type OTHER

Voice evaluation, interviews, ancillary studies

Interventions

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Thyroidectomy

Undergo total thyroidectomy

Intervention Type PROCEDURE

entral lymph node dissection (CLND)

Undergo total thyroidectomy with ipsilateral prophylactic CND

Intervention Type PROCEDURE

Quality-of-life assessment

Voice evaluation, interviews, ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
* No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
* No evidence of distant metastases
* Ability to read and write in English

Exclusion Criteria

* Largest papillary thyroid carcinoma \< 1 cm in size on ultrasound
* Previous thyroid surgery
* Concurrent active malignancy of another type
* Inability to give informed consent or lacks decision making capacity
* T4 tumor
* Pre-existing vocal cord paralysis
* Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
* Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
* Becomes pregnant before surgery or at any time while on study

* Evidence of nodal involvement identified in the operating room (OR)
* Failure to confirm diagnosis of cancer in participant

Minimum Eligible Age

21 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Sippel

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Knigge MA, Robbins D, Thibeault S, Connor N, Sippel R. Secondary analyses of swallowing efficiency and safety outcomes following thyroidectomy versus thyroidectomy plus prophylactic central neck dissection. Thyroid Res. 2025 Sep 16;18(1):45. doi: 10.1186/s13044-025-00264-5.

Reference Type DERIVED

PMID: 40954474 (View on PubMed)

Sippel RS, Robbins SE, Poehls JL, Pitt SC, Chen H, Leverson G, Long KL, Schneider DF, Connor NP. A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer. Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345.

Reference Type DERIVED

PMID: 33759836 (View on PubMed)

Kletzien H, Macdonald CL, Orne J, Francis DO, Leverson G, Wendt E, Sippel RS, Connor NP. Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):995-1003. doi: 10.1001/jamaoto.2018.0309.

Reference Type DERIVED

PMID: 29710208 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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