KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Laryngeal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672904
• Other study ID #: 0057-11-KMC-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2016
• Last updated: October 10, 2016
• Start date: January 2013
• Est. completion date: January 2020

Study information

• Verified date: August 2016
• Source: Kaplan Medical Center
• Contact: Yonatan Lahav, Dr
• Phone: +972-507473045
• Email: Yonatan_L[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Neoplasms

Intervention

Device:
• CO2 laser
surgical removal of carcinoma from the vocal cords with CO2 laser
• KTP laser
surgical removal of carcinoma from the vocal cords with KTP laser

Locations

Country	Name	City	State
Israel	Kapkan medical center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of surgery	total time (minutes) of surgical procedure	intraoperative	Yes
Primary	number of surgical interventions	total number of surgical interventions needed to eliminate the disease	3 years	No
Primary	Recovery time after surgery	recovery in terms of overall function, breathing, swallowing and vocal communication	up to 3 years	No
Primary	voice quality results In the short term	objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire	6 month after last intervention	No
Primary	voice quality results In the long term	objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire	3 years after last intervention	No
Primary	Cure rates in terms of local, regional or distant recurrence events	evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases	3 years after last intervention	No
Primary	Overall survival and disease-dependent survival over a period of at least 3 years		3 years after last intervention	No