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KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

Primary Purpose

Laryngeal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CO2 laser
KTP laser
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Neoplasms focused on measuring vocal cord, carcinoma, ktp laser, co2 laser, endoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kapkan medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CO2 laser

KTP laser

Arm Description

Patients undergoing endoscopic treatment with CO2 laser

Patients undergoing endoscopic treatment with KTP laser

Outcomes

Primary Outcome Measures

Duration of surgery
total time (minutes) of surgical procedure
number of surgical interventions
total number of surgical interventions needed to eliminate the disease
Recovery time after surgery
recovery in terms of overall function, breathing, swallowing and vocal communication
voice quality results In the short term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
voice quality results In the long term
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Cure rates in terms of local, regional or distant recurrence events
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

Secondary Outcome Measures

Full Information

First Posted
January 26, 2016
Last Updated
October 10, 2016
Sponsor
Kaplan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02672904
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Neoplasms
Keywords
vocal cord, carcinoma, ktp laser, co2 laser, endoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CO2 laser
Arm Type
Active Comparator
Arm Description
Patients undergoing endoscopic treatment with CO2 laser
Arm Title
KTP laser
Arm Type
Active Comparator
Arm Description
Patients undergoing endoscopic treatment with KTP laser
Intervention Type
Device
Intervention Name(s)
CO2 laser
Intervention Description
surgical removal of carcinoma from the vocal cords with CO2 laser
Intervention Type
Device
Intervention Name(s)
KTP laser
Intervention Description
surgical removal of carcinoma from the vocal cords with KTP laser
Primary Outcome Measure Information:
Title
Duration of surgery
Description
total time (minutes) of surgical procedure
Time Frame
intraoperative
Title
number of surgical interventions
Description
total number of surgical interventions needed to eliminate the disease
Time Frame
3 years
Title
Recovery time after surgery
Description
recovery in terms of overall function, breathing, swallowing and vocal communication
Time Frame
up to 3 years
Title
voice quality results In the short term
Description
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Time Frame
6 month after last intervention
Title
voice quality results In the long term
Description
objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
Time Frame
3 years after last intervention
Title
Cure rates in terms of local, regional or distant recurrence events
Description
evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases
Time Frame
3 years after last intervention
Title
Overall survival and disease-dependent survival over a period of at least 3 years
Time Frame
3 years after last intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonatan Lahav, Dr
Phone
+972-507473045
Email
Yonatan_L@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yaara Haimovich
Phone
+972-528580806
Email
yaaraha@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonatan Lahav, Dr
Organizational Affiliation
Kaplan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kapkan medical center
City
Rehovot
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonatan Lahav, Dr
Phone
_972-50-7473045
Email
Yonatan_L@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yaara Haimovich
Phone
+972-52-8580806
Email
yaaraha@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19941682
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.
Results Reference
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PubMed Identifier
18710131
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.
Results Reference
background
PubMed Identifier
18317789
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.
Results Reference
background
PubMed Identifier
16944655
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.
Results Reference
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PubMed Identifier
16676821
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.
Results Reference
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PubMed Identifier
11376814
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.
Results Reference
background
PubMed Identifier
17986877
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.
Results Reference
background
PubMed Identifier
17044539
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.
Results Reference
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KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

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