This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Second Military Medical University.
Recruitment status was:  Not yet recruiting
Information provided by:
Second Military Medical University Identifier:
First received: September 29, 2009
Last updated: October 13, 2009
Last verified: October 2009
Endoscopic thyroidectomy has been used to treat thyroid diseases in China. However, whether this technique is rational to treat thyroid carcinoma is still in controversy. The diagnosis of thyroid carcinoma is predominantly made according to intra-operative frozen section pathological examination in China. In this research, the investigators want to compare clinical index (blood loss, operation duration, number of lymph nodes dissected, complication rates, etc) between patients underwent endoscopic thyroidectomy ( total thyroidectomy) and those underwent conversion to open procedure. The investigators want to evaluate the technical feasibility of endoscopic thyroidectomy for treating thyroid carcinoma.

Condition Intervention
Thyroid Carcinoma Procedure: thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion

Resource links provided by NLM:

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • to evaluate the completeness of thyroid resection and clearance of lymph nodes in the central compartment, and to observe the complications such as RLN palsy and hypocalcemia [ Time Frame: 1 year after operation ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: conversion Procedure: thyroidectomy
total thyroidectomy via endoscopic approach and that convert to open procedure
Other Name: totally endoscopic thyroidectomy

Detailed Description:
intra-operative diagnosis of thyroid carcinoma is usually considered the indication of conversion to open surgery. with accumulation of experience of endoscopic thyroidectomy, the investigators want to evaluate the technical feasibility, completeness and safety of endoscopic thyroidectomy.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • lesion diameter less than 1 cm by ultrasound

Exclusion Criteria:

  • frozen section diagnosis indicates benign lesion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00993837

Contact: MIng QIU, Dr. 8621-81885801
Contact: Wei ZHANG, Dr. 8621-81885802

China, Shanghai
Changzheng Hospital Not yet recruiting
Shanghai, Shanghai, China, 200003
Contact: Wei ZHANG, Dr.    8621-81885802   
Contact: Chengxiang SHAN, master    8621-81885804   
Principal Investigator: Daozhen JIANG, Dr.         
Sponsors and Collaborators
Second Military Medical University
Study Chair: Ming QIU, Dr. Changzheng Hospital affliated to SMMU
  More Information

Responsible Party: Minimally Invasive Surgical Center, Changzheng Hospital, Second Military Medical University Identifier: NCT00993837     History of Changes
Other Study ID Numbers: SMMU-2-2009-3
Study First Received: September 29, 2009
Last Updated: October 13, 2009

Keywords provided by Second Military Medical University:
endoscopic thyroidectomy
thyroid carcinoma

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on August 18, 2017