Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
Recruitment status was Not yet recruiting
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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 |
- 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 |
Inclusion Criteria:
- lesion diameter less than 1 cm by ultrasound
Exclusion Criteria:
- frozen section diagnosis indicates benign lesion
Contacts and Locations| Contact: MIng QIU, Dr. | 8621-81885801 | qiuming2006@yahoo.cn |
| Contact: Wei ZHANG, Dr. | 8621-81885802 | zhangwei412@yahoo.com.cn |
| 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. | |
| 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 Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013