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A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.
surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional cryotherapy | Other | 10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional cryotherapy | Procedure | The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn. Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received). |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly | Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate | Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaron har-Shai, M.D | Contact | 972057866206 | yaron07@yahoo.com | |
| Tamir Gil, M.D | Contact | 972507308646 | tamirgiloragil@walla.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaron Har-Shai, M.D | Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lin Medical Center | Recruiting | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21042160 | Background | Har-Shai Y, Brown W, Pallua N, Zouboulis CC. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids. Plast Reconstr Surg. 2010 Nov;126(5):1798-1800. doi: 10.1097/PRS.0b013e3181ef823d. No abstract available. | |
| 18757392 | Background | Har-Shai Y, Brown W, Labbe D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds. 2008 Sep;7(3):169-75. doi: 10.1177/1534734608322813. |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 12963913 | Background | Giuffrida TJ, Jimenez G, Nouri K. Histologic cure of basal cell carcinoma treated with cryosurgery. J Am Acad Dermatol. 2003 Sep;49(3):483-6. doi: 10.1067/s0190-9622(03)00903-4. |
| D018295 |
| Neoplasms, Basal Cell |