Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

April 20, 2016 updated by: Jee soo Kim, Samsung Medical Center

Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study

Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 2
  • 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 Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Jee Soo Kim, M.D., Ph.D.
          • Phone Number: 82-2-3410-3479

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • papillary carcinoma of thyroid (less than 4cm)
  • no evidence of lymph node metastasis in preoperative work-up result
  • the patients who accept this study

Exclusion Criteria:

  • large thyroid cancer( > 4cm)
  • morbid
  • anticoagulation agent usage
  • endoscopic or robotic thyroid operation
  • evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C group
Routine central neck dissection
Procedure: Routine central neck dissection
Level VI neck node dissection during thyroid operation
No Intervention: N group
No central neck node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is routine neck node dissection necessary in micro PTC?
Time Frame: Until 5 year follow-up. (Dec. 2016)

To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u).

To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.
Until 5 year follow-up. (Dec. 2016)

Secondary Outcome Measures

Outcome Measure
Time Frame
The efficacy of sentinel lymph node biopsy in micro PTC
Time Frame: Until 5 year follow-up. (Dec. 2016)
Until 5 year follow-up. (Dec. 2016)

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Study Chair: Jee Soo Kim, M.D., Ph.D., Samsung Medical Center

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

May 1, 2009

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-02-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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