Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma

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.
ClinicalTrials.gov Identifier: NCT01103557
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : April 14, 2010
Sponsor:
Information provided by:
Pusan National University Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2010
First Posted Date  ICMJE April 14, 2010
Last Update Posted Date April 14, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma
Official Title  ICMJE The Effectiveness of Prophylactic Selective Lateral Neck Dissection in Papillary Thyroid Carcinoma Patients With Central Neck Metastasis
Brief Summary The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).
Detailed Description The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Thyroid Neoplasm
  • Lymphatic Metastasis
Intervention  ICMJE Procedure: prophylactic selective lateral neck dissection
Level II, III, IV lymph node dissection
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April¬†13,¬†2010)
62
Original Actual Enrollment  ICMJE Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Papillary thyroid carcinoma with central neck metastasis
  • No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography

Exclusion Criteria:

  • History of previous thyroid operation
  • Isthmic thyroid lesion
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103557
Other Study ID Numbers  ICMJE PTC_CND_LND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yun-Sung Lim, Pusan National University Hospital
Study Sponsor  ICMJE Pusan National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pusan National University Hospital
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP