CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved

Study Overview
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Brief Summary
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Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.

Official Title
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Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved

Conditions
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Squamous Cell Carcinoma of Glottis

Intervention / Treatment
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* Procedure: CO2 Laser surgery
* Procedure: Open Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T1N0 SCC of glottic carcinoma with anterior commissure involve 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: With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients Patients with pregnancy and lactation Have surgery contraindications

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 laser surgery<br>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. | Procedure: CO2 Laser surgery<br>* Patients were randomly assigned to CO2 laser surgery group and open Surgery group.<br>|
| Other: Open surgery<br>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. | Procedure: Open Surgery<br>* Patients were randomly assigned to CO2 laser surgery group and open Surgery group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CO2 laser surgery, open surgery, multicenter prospective, randomized, controlled clinical studies, T1N0 squamous cell carcinoma of glottis with anterior commissure involved