CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
NCT ID: NCT02303457
Last Updated: 2016-01-28
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
402 participants
INTERVENTIONAL
2014-07-31
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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CO2 laser surgery
CO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage.
CO2 Laser surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Open surgery
Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved.
open surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm.
Open Surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Interventions
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CO2 Laser surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Open Surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Eligibility Criteria
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Inclusion Criteria
* No nodal metastasis and distant metastasis
* All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
* Expected lifetime\>1 year
* Patients and families agreed to participate in the test and sign the informed consent
* Without cognitive impairment.
Exclusion Criteria
* Patients with pregnancy and lactation
* Have surgery contraindications
20 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Xuekui Liu
OTHER
Responsible Party
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Xuekui Liu
chief physician
Principal Investigators
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ye cao, doctor
Role: STUDY_DIRECTOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014012
Identifier Type: -
Identifier Source: org_study_id
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