Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma

Thyroid Carcinoma Clinical Trial

Official title:

Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00993837
• Other study ID #: SMMU-2-2009-3
• Status: Not yet recruiting
• Phase: N/A
• First received: September 29, 2009
• Last updated: October 13, 2009
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2009
• Source: Second Military Medical University
• Contact: MIng QIU, Dr.
• Phone: 8621-81885801
• Email: qiuming2006[@]yahoo.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• lesion diameter less than 1 cm by ultrasound

Exclusion Criteria:

• frozen section diagnosis indicates benign lesion

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• thyroidectomy
total thyroidectomy via endoscopic approach and that convert to open procedure

Locations

Country	Name	City	State
China	Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year after operation	Yes