KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Study Overview
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Brief Summary
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comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser

Detailed Description
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Randomized controlled double-blinded study. The study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or T1a-b,N0M0 squamous cell carcinoma. Patients will undergo examination and treatment and at least 3 years of follow-up. 40 cancer patients will be included. The participants will be randomly divided into two groups: the first will be treated by KTP laser and the second by CO2 laser. The patients will be blinded to the method of treatment. To enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. The investigator in charge of collecting the data after the operation will be blinded to the treatment method. Each participant will undergo pre-operative evaluation and follow-up after surgery in both arms. Preoperative evaluation will include: Voice Handicap Index questionnaire GRBAS - subjective assessment of voice quality. Video-stroboscopy of vocal cords Voice Analysis . Follow-up after surgery: Visit 6 weeks after surgery (± two weeks), and then every three months (± 6 weeks). repeated full evaluation (questionnaire, GRBAS, Stroboscopy, voice analysis) in 30 weeks of follow up and 3 years of follow up.

Official Title
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Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords

Conditions
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Laryngeal Neoplasms

Intervention / Treatment
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* Device: CO2 laser
* Device: KTP laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma). Exclusion Criteria: Patients who underwent previous significant vocal cords surgical intervention , or irradiation. Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO2 laser<br>Patients undergoing endoscopic treatment with CO2 laser | Device: CO2 laser<br>* surgical removal of carcinoma from the vocal cords with CO2 laser<br>|
| Active Comparator: KTP laser<br>Patients undergoing endoscopic treatment with KTP laser | Device: KTP laser<br>* surgical removal of carcinoma from the vocal cords with KTP laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | total time (minutes) of surgical procedure | intraoperative | 
| number of surgical interventions | total number of surgical interventions needed to eliminate the disease | 3 years | 
| Recovery time after surgery | recovery in terms of overall function, breathing, swallowing and vocal communication | up to 3 years | 
| voice quality results In the short term | objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire | 6 month after last intervention | 
| voice quality results In the long term | objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire | 3 years after last intervention | 
| Cure rates in terms of local, regional or distant recurrence events | evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases | 3 years after last intervention | 
| Overall survival and disease-dependent survival over a period of at least 3 years |  | 3 years after last intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vocal cord, carcinoma, ktp laser, co2 laser, endoscopic surgery