KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
NCT ID: NCT02672904
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2013-01-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CO2 laser
Patients undergoing endoscopic treatment with CO2 laser
CO2 laser
surgical removal of carcinoma from the vocal cords with CO2 laser
KTP laser
Patients undergoing endoscopic treatment with KTP laser
KTP laser
surgical removal of carcinoma from the vocal cords with KTP laser
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)
18 Years
ALL
No
Sponsors
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Kaplan Medical Center
OTHER
Responsible Party
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Dr Yonatan Lahav
Dr Yonatan Lahav
Principal Investigators
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Yonatan Lahav, Dr
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center
Locations
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Kapkan medical center
Rehovot, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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. doi: 10.1177/000348940611500802.
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.
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.
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.
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.
Other Identifiers
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0057-11-KMC-CTIL
Identifier Type: -
Identifier Source: org_study_id
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