Clinical Trial: KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: Kaplan Medical Center

Current Primary Outcome:

  • Duration of surgery [ Time Frame: intraoperative ]
    total time (minutes) of surgical procedure
  • number of surgical interventions [ Time Frame: 3 years ]
    total number of surgical interventions needed to eliminate the disease
  • Recovery time after surgery [ Time Frame: up to 3 years ]
    recovery in terms of overall function, breathing, swallowing and vocal communication
  • voice quality results In the short term [ Time Frame: 6 month after last intervention ]
    objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
  • voice quality results In the long term [ Time Frame: 3 years after last intervention ]
    objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
  • Cure rates in terms of local, regional or distant recurrence events [ Time Frame: 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 [ Time Frame: 3 years after last intervention ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kaplan Medical Center

Dates:
Date Received: January 26, 2016
Date Started: January 2013
Date Completion: January 2020
Last Updated: October 10, 2016
Last Verified: August 2016