KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords
1 other identifier
interventional
40
1 country
1
Brief Summary
comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 26, 2016
CompletedFirst Posted
Study publicly available on registry
February 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 11, 2016
August 1, 2016
6 years
January 26, 2016
October 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Duration of surgery
total time (minutes) of surgical procedure
intraoperative
number of surgical interventions
total number of surgical interventions needed to eliminate the disease
3 years
Recovery time after surgery
recovery in terms of overall function, breathing, swallowing and vocal communication
up to 3 years
voice quality results In the short term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
6 month after last intervention
voice quality results In the long term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
3 years after last intervention
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
Overall survival and disease-dependent survival over a period of at least 3 years
3 years after last intervention
Study Arms (2)
CO2 laser
ACTIVE COMPARATORPatients undergoing endoscopic treatment with CO2 laser
KTP laser
ACTIVE COMPARATORPatients undergoing endoscopic treatment with KTP laser
Interventions
Eligibility Criteria
You may qualify if:
- Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kapkan medical center
Rehovot, Israel
Related 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.
PMID: 19941682BACKGROUNDZeitels 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.
PMID: 18710131BACKGROUNDLin 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.
PMID: 18317789BACKGROUNDZeitels 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.
PMID: 16944655BACKGROUNDHirano 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.
PMID: 16676821BACKGROUNDKacker 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.
PMID: 11376814BACKGROUNDZeitels 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.
PMID: 17986877BACKGROUNDZeitels 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.
PMID: 17044539BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yonatan Lahav, Dr
Kaplan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Yonatan Lahav
Study Record Dates
First Submitted
January 26, 2016
First Posted
February 3, 2016
Study Start
January 1, 2013
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
October 11, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share