KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02672904|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : October 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Laryngeal Neoplasms||Device: CO2 laser Device: KTP laser||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Active Comparator: CO2 laser
Patients undergoing endoscopic treatment with CO2 laser
Device: CO2 laser
surgical removal of carcinoma from the vocal cords with CO2 laser
Active Comparator: KTP laser
Patients undergoing endoscopic treatment with KTP laser
Device: KTP laser
surgical removal of carcinoma from the vocal cords with KTP laser
- Duration of surgery [ Time Frame: intraoperative ]total time (minutes) of surgical procedure
- number of surgical interventions [ Time Frame: 3 years ]total number of surgical interventions needed to eliminate the disease
- Recovery time after surgery [ Time Frame: up to 3 years ]recovery in terms of overall function, breathing, swallowing and vocal communication
- voice quality results In the short term [ Time Frame: 6 month after last intervention ]objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
- voice quality results In the long term [ Time Frame: 3 years after last intervention ]objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire
- Cure rates in terms of local, regional or distant recurrence events [ Time Frame: 3 years after last intervention ]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 [ Time Frame: 3 years after last intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672904
|Contact: Yonatan Lahav, Dr||+972-507473045||Yonatan_L@clalit.org.il|
|Contact: Yaara Haimovichfirstname.lastname@example.org|
|Kapkan medical center||Recruiting|
|Contact: Yonatan Lahav, Dr _972-50-7473045 Yonatan_L@clalit.org.il|
|Contact: Yaara Haimovich +972-52-8580806 email@example.com|
|Principal Investigator:||Yonatan Lahav, Dr||Kaplan Medical Center|