CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved

NCT ID: NCT02303457

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2024-07-31

Brief Summary

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Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.

Detailed Description

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Conditions

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Squamous Cell Carcinoma of Glottis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CO2 laser surgery

CO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage.

Group Type EXPERIMENTAL

CO2 Laser surgery

Intervention Type PROCEDURE

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Open surgery

Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved.

open surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm.

Group Type OTHER

Open Surgery

Intervention Type PROCEDURE

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Interventions

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CO2 Laser surgery

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Intervention Type PROCEDURE

Open Surgery

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* T1N0 SCC of glottic carcinoma with anterior commissure involve
* No nodal metastasis and distant metastasis
* All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
* Expected lifetime\>1 year
* Patients and families agreed to participate in the test and sign the informed consent
* Without cognitive impairment.

Exclusion Criteria

* With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
* Patients with pregnancy and lactation
* Have surgery contraindications
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Xuekui Liu

OTHER

Sponsor Role lead

Responsible Party

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Xuekui Liu

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ye cao, doctor

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xuekui liu, doctor

Role: CONTACT

(86-20) 8734 3768

Facility Contacts

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xuekui liu, doctor

Role: primary

(86-20) 8734 3768

Other Identifiers

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2014012

Identifier Type: -

Identifier Source: org_study_id

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