Feasibility of Endoscopic Thyroidectomy for 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. Identifier: NCT00993837
Recruitment Status : Unknown
Verified October 2009 by Second Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Information provided by:
Second Military Medical University

Brief Summary:
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 or disease Intervention/treatment
Thyroid Carcinoma Procedure: 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Arm Intervention/treatment
Experimental: conversion Procedure: thyroidectomy
total thyroidectomy via endoscopic approach and that convert to open procedure
Other Name: totally endoscopic thyroidectomy

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 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