Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 14, 2009
October 1, 2009
1.9 years
September 29, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
1 year after operation
Study Arms (1)
conversion
EXPERIMENTALInterventions
total thyroidectomy via endoscopic approach and that convert to open procedure
Eligibility Criteria
You may qualify if:
- lesion diameter less than 1 cm by ultrasound
You may not qualify if:
- frozen section diagnosis indicates benign lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ming QIU, Dr.
Changzheng Hospital affliated to SMMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 29, 2009
First Posted
October 14, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
June 1, 2012
Last Updated
October 14, 2009
Record last verified: 2009-10