Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors.

Study Overview
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Brief Summary
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This study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with Mohs surgery combind with cryotherapy than Mohs surgery only.

Detailed Description
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This study is a randomized perspective study. American Joint Committee on Cancer was applied to define the cancer stage of patients recruited. Patients with Tis to T3cN0M0 will be randomized to receive Mohs surgery or Mohs suregery conbind cryotherapy. Patients will be followed for 3 years.

Official Title
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Mohs Surgery Combind With Cryotherapy for Eyelid Malignant Tumors: a Prospective Randomized Controlled Study.

Conditions
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Eyelid Tumor

Intervention / Treatment
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* Procedure: Mohs surgery
* Procedure: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of this study. Definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, Stage Tis to T3CN0M0 based on American Joint Committee on Cancer. Pathological examination showed the primary tumor was compeletely resected Exclusion Criteria: Any previous treatment in the study eye Tumor complicated with infection Any other tumors of the paticipants Intolerate of surgery or anesthesia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mohs surgery conbind with cryotherapy<br>patients in this group received both Mohs surgery and cryotherapy. | Procedure: Mohs surgery<br>* Mohs surgery of eyelid<br>Procedure: cryotherapy<br>* cryotherapy of eyelid<br>|
| Active Comparator: Mohs surgery<br>patients in this group received only Mohs surgery. | Procedure: Mohs surgery<br>* Mohs surgery of eyelid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate of tumor | measure the tumor recurrence rate for the two groups at three years | three years | 
| progression rate of tumor | measure the tumor progression rate for the two groups at three years | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortailty | measure the mortality rate for the two groups(Cancer-related death and non-Cancer-related death) at three years | three years | 
| side effects of Mohs surgery and cryotherapy in the treatment of eyelid malignant tumor | numbers of participants with side effects | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eyelid Tumor, Basal Cell Carcinoma, Squamous Cell Carcinoma, Sebaceous Carcinoma, Mohs surgery, cryotherapy