A Clinical Study of Transaxillary Endoscopic and Open Thyroidectomy for PTC
NCT ID: NCT05545852
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
290 participants
INTERVENTIONAL
2021-06-01
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study Group
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Control Group
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
COT(Conventional Open Thyroidectomy)
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Interventions
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GTPET(Gasless Transaxillary Posterial Endoscopic Thyroidectomy)
Gasless Transaxillary Posterial Endoscopic Thyroidectomy and Ipsilateral Central Lymph Node Dissection
COT(Conventional Open Thyroidectomy)
Conventional Open Thyroidectomy and Ipsilateral Central Lymph Node Dissection
Eligibility Criteria
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Inclusion Criteria
* 18 years old \< age \< 70 years old;
* Papillary thyroid carcinoma (Bethesda grade V-VI) was pathologically diagnosed by fine needle aspiration biopsy of the primary thyroid tumor before surgery;
* Color Doppler TI-RADS 4c-5 of primary thyroid tumor;
* The preoperative clinical staging is T1, N0-1a, M0 (see diagnostic criteria for details; according to AJCC-8th TNM tumor staging);
* It is expected that R0 surgical results can be obtained by performing single thyroid lobectomy and isthmus resection + ipsilateral central lymph node dissection;
* Preoperative ASA score I-III.
Exclusion Criteria
* Suffering from serious mental illness;
* Preoperative imaging examinations suggest that the tumor is located in the thyroid isthmus or involves bilateral lobes;
* Preoperative imaging examinations suggest the possibility of cervical lateral lymph node or distant metastasis;
* Hashimoto's thyroiditis combined with hyperthyroidism or abnormal thyroid function;
* History of neck surgery;
* History of thyroid surgery (including ablation therapy for thyroid nodules);
* Family history of thyroid cancer;
* History of childhood ionizing radiation exposure;
* History of other malignant diseases within 5 years;
* A history of unstable angina or myocardial infarction within 6 months;
* History of cerebral infarction or cerebral hemorrhage within 6 months;
* History of continuous systemic corticosteroid therapy within 1 month;
* Concurrent surgical treatment of other diseases is required;
* Patients who are judged by the investigator to be unsuitable to participate in this trial.
18 Years
70 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Shangtong Lei, Dr.
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Registration on Chinese Clinical Trial Registry
Other Identifiers
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NFEC-2021-324
Identifier Type: -
Identifier Source: org_study_id
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