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Trial record 2 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Neoplasms"

KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02672904
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Yonatan Lahav, Kaplan Medical Center

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

Condition or disease Intervention/treatment Phase
Laryngeal Neoplasms Device: CO2 laser Device: KTP laser Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Duration of surgery [ Time Frame: intraoperative ]
    total time (minutes) of surgical procedure

  2. number of surgical interventions [ Time Frame: 3 years ]
    total number of surgical interventions needed to eliminate the disease

  3. Recovery time after surgery [ Time Frame: up to 3 years ]
    recovery in terms of overall function, breathing, swallowing and vocal communication

  4. 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

  5. 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

  6. 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

  7. Overall survival and disease-dependent survival over a period of at least 3 years [ Time Frame: 3 years after last intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Yonatan Lahav, Dr +972-507473045 Yonatan_L@clalit.org.il
Contact: Yaara Haimovich +972-528580806 yaaraha@clalit.org.il

Locations
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Israel
Kapkan medical center Recruiting
Rehovot, Israel
Contact: Yonatan Lahav, Dr    _972-50-7473045    Yonatan_L@clalit.org.il   
Contact: Yaara Haimovich    +972-52-8580806    yaaraha@clalit.org.il   
Sponsors and Collaborators
Kaplan Medical Center
Investigators
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Principal Investigator: Yonatan Lahav, Dr Kaplan Medical Center

Publications:

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Responsible Party: Dr Yonatan Lahav, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02672904     History of Changes
Other Study ID Numbers: 0057-11-KMC-CTIL
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Yonatan Lahav, Kaplan Medical Center:
vocal cord
carcinoma
ktp laser
co2 laser
endoscopic surgery

Additional relevant MeSH terms:
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Neoplasms
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases