KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
Study Details
Study Description
Brief Summary
comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CO2 laser Patients undergoing endoscopic treatment with CO2 laser |
Device: CO2 laser
surgical removal of carcinoma from the vocal cords with CO2 laser
|
| Active Comparator: KTP laser Patients undergoing endoscopic treatment with KTP laser |
Device: KTP laser
surgical removal of carcinoma from the vocal cords with KTP laser
|
Outcome Measures
Primary Outcome Measures
- Duration of surgery [intraoperative]
total time (minutes) of surgical procedure
- number of surgical interventions [3 years]
total number of surgical interventions needed to eliminate the disease
- Recovery time after surgery [up to 3 years]
recovery in terms of overall function, breathing, swallowing and vocal communication
- 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
- 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]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kapkan medical center | Rehovot | Israel |
Sponsors and Collaborators
- Kaplan Medical Center
Investigators
- Principal Investigator: Yonatan Lahav, Dr, Kaplan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Burns JA, Friedman AD, Lutch MJ, Hillman RE, Zeitels SM. Value and utility of 532 nanometre pulsed potassium-titanyl-phosphate laser in endoscopic laryngeal surgery. J Laryngol Otol. 2010 Apr;124(4):407-11. doi: 10.1017/S0022215109991824. Epub 2009 Nov 27.
- Hirano S, Yamashita M, Kitamura M, Takagita S. Photocoagulation of microvascular and hemorrhagic lesions of the vocal fold with the KTP laser. Ann Otol Rhinol Laryngol. 2006 Apr;115(4):253-9.
- Kacker A, April M, Ward RF. Use of potassium titanyl phosphate (KTP) laser in management of subglottic hemangiomas. Int J Pediatr Otorhinolaryngol. 2001 May 31;59(1):15-21.
- Lin DS, Cheng SC, Su WF. Potassium titanyl phosphate laser treatment of intubation vocal granuloma. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1233-8. doi: 10.1007/s00405-008-0628-6. Epub 2008 Mar 4.
- Zeitels SM, Akst LM, Bums JA, Hillman RE, Broadhurst MS, Anderson RR. Pulsed angiolytic laser treatment of ectasias and varices in singers. Ann Otol Rhinol Laryngol. 2006 Aug;115(8):571-80.
- Zeitels SM, Akst LM, Burns JA, Hillman RE, Broadhurst MS, Anderson RR. Office-based 532-nm pulsed KTP laser treatment of glottal papillomatosis and dysplasia. Ann Otol Rhinol Laryngol. 2006 Sep;115(9):679-85.
- Zeitels SM, Burns JA, Lopez-Guerra G, Anderson RR, Hillman RE. Photoangiolytic laser treatment of early glottic cancer: a new management strategy. Ann Otol Rhinol Laryngol Suppl. 2008 Jul;199:3-24.
- Zeitels SM, Burns JA. Office-based laryngeal laser surgery with the 532-nm pulsed-potassium-titanyl-phosphate laser. Curr Opin Otolaryngol Head Neck Surg. 2007 Dec;15(6):394-400. Review.
- 0057-11-KMC-CTIL