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NCT Number: NCT00795782

Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.

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Key information

Conditions

Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma.

Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings.

Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection.

Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study.

Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND)

Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 70
  • Sonographically node-negative cytology confirmed thyroid papillary carcinoma
  • Tumor size less than 1 cm in sonography
  • Tumor confined to the one lobe of the thyroid gland
  • One who provides the informed consent

Exclusion criteria

  • History of radiation treatment to head and neck area
  • History of other malignancy except thyroid cancer
  • Poor performance status (ECOG 3-4)

Treatment and study plan

Prophylactic central lymph node dissection

Procedure

prophylactic ipsilateral versus bilateral central lymph node dissection

Primary outcomes

  1. Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)

    Time frame: 3 year after initial treatment

Secondary outcomes

  1. Postoperative complications(hypocalcemia, hoarseness)

    Time frame: up to 3 years after surgery

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Nov 21, 2008
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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