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Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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 Design

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • lesion diameter less than 1 cm by ultrasound

Exclusion Criteria:

  • frozen section diagnosis indicates benign lesion
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00993837


Contacts
Contact: MIng QIU, Dr. 8621-81885801 qiuming2006@yahoo.cn
Contact: Wei ZHANG, Dr. 8621-81885802 zhangwei412@yahoo.com.cn

Locations
China, Shanghai
Changzheng Hospital Not yet recruiting
Shanghai, Shanghai, China, 200003
Contact: Wei ZHANG, Dr.    8621-81885802    zhangwei412@yahoo.com.cn   
Contact: Chengxiang SHAN, master    8621-81885804    chengxiangshan@hotmail.com   
Principal Investigator: Daozhen JIANG, Dr.         
Sponsors and Collaborators
Second Military Medical University
Investigators
Study Chair: Ming QIU, Dr. Changzheng Hospital affliated to SMMU
More Information

Responsible Party: Minimally Invasive Surgical Center, Changzheng Hospital, Second Military Medical University
ClinicalTrials.gov 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:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms