Clinical trial NCT02672904: KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
Official title: Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Neoplasms
Keywords: vocal cord
carcinoma
ktp laser
co2 laser
endoscopic surgery
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Duration of surgery
timeFrame: intraoperative
measure: number of surgical interventions
timeFrame: 3 years
measure: Recovery time after surgery
timeFrame: up to 3 years
measure: voice quality results In the short term
timeFrame: 6 month after last intervention
measure: voice quality results In the long term
timeFrame: 3 years after last intervention
measure: Cure rates in terms of local, regional or distant recurrence events
timeFrame: 3 years after last intervention
measure: Overall survival and disease-dependent survival over a period of at least 3 years
timeFrame: 3 years after last intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kapkan medical center
Study officials:
affiliation: Kaplan Medical Center
name: Yonatan Lahav, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1177/00034894081170s701.
citation: 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.
citation: 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. doi: 10.1177/000348940611500802.
citation: 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. doi: 10.1177/000348940611500402.
citation: 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. doi: 10.1016/s0165-5876(01)00451-7.
citation: 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. doi: 10.1097/MOO.0b013e3282f1fbb2.
citation: 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. doi: 10.1177/000348940611500905.