KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma

October 10, 2016 updated by: Dr Yonatan Lahav, Kaplan Medical Center

Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: intraoperative
total time (minutes) of surgical procedure
intraoperative
number of surgical interventions
Time Frame: 3 years
total number of surgical interventions needed to eliminate the disease
3 years
Recovery time after surgery
Time Frame: up to 3 years
recovery in terms of overall function, breathing, swallowing and vocal communication
up to 3 years
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
6 month after last intervention
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
3 years after last intervention
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
3 years after last intervention
Overall survival and disease-dependent survival over a period of at least 3 years
Time Frame: 3 years after last intervention
3 years after last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Investigators

  • Principal Investigator: Yonatan Lahav, Dr, Kaplan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0057-11-KMC-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Laryngeal Neoplasms

Clinical Trials on CO2 laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe