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

Not Applicable

• Conditions: Squamous Cell Carcinoma of Glottis
• Interventions: Procedure: Open Surgery; Procedure: CO2 Laser surgery

• Registration Number: NCT02303457
• Lead Sponsor: Xuekui Liu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Open surgery	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.
CO2 laser surgery	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.

Primary Outcome Measures

Name	Time	Method
disease-free survival	5 years

Secondary Outcome Measures

Name	Time	Method
recurrence rate	5 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China