Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Second Military Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Second Military Medical University
ClinicalTrials.gov Identifier:
NCT00993837
First received: September 29, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 29, 2009
Last Updated: October 13, 2009
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 22, 2014