KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Not Applicable

• Conditions: Laryngeal Neoplasms

• Registration Number: NCT02672904
• Lead Sponsor: Kaplan Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kapkan medical center; 🇮🇱 Rehovot, Israel