Back to resultsFeasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
Primary Purpose
Thyroid Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Carcinoma focused on measuring endoscopic thyroidectomy, thyroid carcinoma
Eligibility Criteria
Inclusion Criteria:
- lesion diameter less than 1 cm by ultrasound
Exclusion Criteria:
- frozen section diagnosis indicates benign lesion
Sites / Locations
- Changzheng Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
conversion
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00993837
First Posted
September 29, 2009
Last Updated
October 13, 2009
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00993837
Brief Title
Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
Official Title
Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Second Military Medical University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma
Keywords
endoscopic thyroidectomy, thyroid carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conversion
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
thyroidectomy
Other Intervention Name(s)
totally endoscopic thyroidectomy
Intervention Description
total thyroidectomy via endoscopic approach and that convert to open procedure
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lesion diameter less than 1 cm by ultrasound
Exclusion Criteria:
frozen section diagnosis indicates benign lesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MIng QIU, Dr.
Phone
8621-81885801
Email
qiuming2006@yahoo.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei ZHANG, Dr.
Phone
8621-81885802
Email
zhangwei412@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming QIU, Dr.
Organizational Affiliation
Changzheng Hospital affliated to SMMU
Official's Role
Study Chair
Facility Information:
Facility Name
Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei ZHANG, Dr.
Phone
8621-81885802
Email
zhangwei412@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Chengxiang SHAN, master
Phone
8621-81885804
Email
chengxiangshan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Daozhen JIANG, Dr.
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
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