Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

April 13, 2016 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UniCND
Limited/ipsilateral central lymph node dissection
Procedure: Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
Active Comparator: BiCND
Comprehensive/bilateral central lymph node dissection
Procedure: Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
No Intervention: NoCND
No central lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
Time Frame: 3 year after initial treatment
3 year after initial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications(hypocalcemia, hoarseness)
Time Frame: up to 3 years after surgery
up to 3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Han-Sin Jeong, MD, PhD, Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-09-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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