Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
October 13, 2009 updated by: Second Military Medical University
Comparison of Effectiveness and Safety of Thyroidectomy for Thyroid Carcinoma in Patients Undergo Endoscopic Surgery and Those Receive Conversion
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200003
- Changzheng hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- lesion diameter less than 1 cm by ultrasound
Exclusion Criteria:
- frozen section diagnosis indicates benign lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: conversion
|
total thyroidectomy via endoscopic approach and that convert to open procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 year after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ming QIU, Dr., Changzheng Hospital affliated to SMMU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
September 29, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 14, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2009
Last Update Submitted That Met QC Criteria
October 13, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMMU-2-2009-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.