KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Kaplan Medical Center

Status: Unknown

Conditions: Laryngeal Neoplasms

Treatments: Device: KTP laser; Device: CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02672904

0057-11-KMC-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

CO2 laser

Active Comparator group

Description:

Patients undergoing endoscopic treatment with CO2 laser

Treatment:

Device: CO2 laser

KTP laser

Active Comparator group

Description:

Patients undergoing endoscopic treatment with KTP laser

Treatment:

Device: KTP laser