Clinical Trial: The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma

Brief Summary: The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma.

Detailed Summary:

The aim of this study is to investigate the efficacy and safety of prophylactic central lymph node dissection in papillary thyroid carcinoma. Primary outcome is the structural recurrence rate. Secondary outcomes are operative time, postoperative complications, and quality of life.

The enrolled patients were randomly assigned to control group and intervention group (1:1 allocation).

Sponsor: Seoul National University Hospital

Current Primary Outcome: Recurrence of thyroid cancer [ Time Frame: Participants will be followed from the operation to 7 year (maximum) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• operation time [ Time Frame: up to 6 hours after operation ]
  operation time will be measured by attending nurse
• postoperative complications including hypoparathyroidism and recurrent nerve palsy [ Time Frame: 6 months postoperatively ]
  At outpatient clinic (6months posteoperatively), video laryngoscopic exam and serum parathyroid hormone with serum calcium will be measured. Type and number of complications will be recoreded
• Quality of life [ Time Frame: 9 months postoperatively ]
  Quality of life will be measured by using SF-36 questionnaire

Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: April 7, 2015
Date Started: April 2015
Date Completion: February 2022
Last Updated: October 23, 2016
Last Verified: October 2016