- Email: [email protected]
Guidelines of care for cryosurgery
Journal of the American Academy of Dermatology October 1994
Drake et al. dosage forms of oral methoxsalen in psoralens plus ultraviolet A therapy of psoriasis. J AM ACAD DERMATOL 1987; 16:994-8. Morison WL. Phototherapy and photochemotherapy of skin disease. New York: Raven Press, 1991. Morison WL, Momtaz K, Mosher DB, et al. UVB phototherapy in the prophylaxis of polymorphous light eruption. Br J DermatoI1982;106:231-3. Morison WL, Parrish J, Fitzpatrick TB. Oral psoralen photochemotherapy of atopic eczema. Br 1 Dermatol 1978;98:2530. N yfors A, Dahl-N yfors B, Hopwood D. Liver biopsies from patients with psoriasis related to photochemotherapy (PUVA): findings before and after 1 year of therapy in twelve patients. lAM ACAD DERMATOL 1986;14:43-8. Ortonne JP, Mosher DB, Fitzpatrick TB. Vitiligo and other hypomelanoses of hair and skin. New York: Plenum Medical, 1983:260-86. Parrish lA, Chylack LT, Woehler ME, et al. Dermatological and ocular examinations in rabbits chronically photosensitized with methoxsalen. J Invest Dermatol 1979;73: 250-5. Parrish lA, Fitzpatrick TB, Tanenbaum L, et al. Photochemotherapy of psoriasis with oral methoxsalen and longwave ultraviolet light. N Engl 1 Med 1974;291 :1207-1l. Picascia DD, Rothe M, Goldberg NS, et al. Antinuclear antibodies during psoralens plus ultraviolet A (PUVA) thera-
py-Are they worthwhile? JAM ACADDERMATOL 1987; 16:574-7. Prystowsky Jl-l, Keen MS, DeLeo VA. Measurement of the transmittance of ultraviolet and visibleradiation through human eyelids. Photochem Photobiol 1990;51:38. Ramsay CA. Solar urticaria treatment by inducing tolerance to artificial radiation and natural light. Arch Dermatol 1977;113:1222-5. Ros AM. PUVA therapy for erythropoietic protoporphyria. Photodermatology 1988;5:148-9. Saltzer EI. Relief from uremic pruritus: a therapeutic approach. Cutis 1975;16:298-9. Stern RS, Kleinerman RA, Parrish lA, et al. Phototoxic reactions to photoactive drugs in patients treated with PUVA. Arch Dermatol 1980;116:1269-71. Stern RS, Morison WL, Thibodeau LA, et al. Antinuclear antibodies and oral methoxsalen photochemotherapy (PUVA) for psoriasis. Arch DermatoI1979;115:1320-4. Stern RS, Parrish lA, Fitzpatrick TB. Ocular findings in patients treated withPUVA. J Invest Derrnatol 1985;85:26973. Tuffanelli DL. Antinuclear antibodies and photosensitivity in lupus erythematosus-Relevant in PUVA therapy? [Editorial] JAM ACAD DERMATOL 1987;16:614-6. Zachariae H, Kragballe K, Sogaard H. Liver biopsy in PUVAtreated patients. Acta Derm Venereol (Stockh) 1979;59:26870.
This report reflects the best data available at the time the report was prepared, but caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for cryosurgery Committee on Guidelines of Care: Lynn A. Drake, MD, Chairman, Roger I. Ceilley, MD, Raymond L. Cornelison, MD, William L. Dobes, MD, William Dorner, MD, Robert W. Goltz, MD, Charles W. Lewis, MD, Stuart 1. Salasche, MD, Maria L. Chanco Turner, MD, and Barbara J. Lowery, MPH Task Force on Cryosurgery: Gloria F. Graham, MD, Chairman, Richard L. DetIefs, MD, Algin B. Garrett, MD, Emanuel G. Kuflik, MD, and Ronald R. Lubritz, MD I. Introduction The American Academy of Dermatology's Committee on Guidelines of Care is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession Reprint requests: American Academy of Dermatology, P.O. Box4014, Schaumburg, IL 60168·4014. JAM ACAD DERMAToL 1994;31:648-53. Copyright © 1994 by the American Academy of Dermatology, Inc. 0190-9622/94 $3.00
648
+ 0 16/1/57562
in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice in countries outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
II. Definition Cryosurgery is a procedure utilizing cryogenic agents to treat a variety of cutaneous diseases. Freezing temperatures of a cryogenic agent applied directly or indirectly to the skin cause local destruc-
Journal of the American Academy of Dermatology Volume 31, Number 4
tion of tissue. Certain conditions may require multiple or repeated treatments. Cryotherapy, a term used for many years, is best reserved for more superficial forms of freezing. This guidelineprimarily addresses the scope of cryosurgery. III. Rationale A . Scope Millions of people are affected annually by a wide variety of cutaneous and mucocutaneous disorders for which cryosurgery can be an effective treatment. A variety of benign lesions develop in children, teenagers , and adults. In addition, premalignant dermatoses, premalignant tumors, and malignant tumors develop with increasing age, many related to exposure to UV radiation. Single or multiple lesions on all areas of the body can be eradicated with cryosurgery. These cryosurgery guidelines identify appropriate care, expectations, morbidity, and complications. The following are some conditions that may be amenable to cryosurgery: 1. Benign lesions a) Acne vulgaris, cystic b) Angiolymphoid hyperplasia c) Angiokeratoma-Fordyce and solitary type d) Angioma, cherry and spider e) Chondrodermatitis nodularis chronicus helicis j) Dermatofibroma g) Disseminated superficial actinic porokeratosis h) Granuloma faciale i) Granuloma fissuratum j) Hemangioma, strawberry and cavernous k) Hidradenitis suppurativa /) Keloid m) Leishmaniasis n) Lentigines, lentigo simplex, solar lentigo 0) Lichen planus, hypertrophic form p) Lichen sclerosus et atrophicus q) Lichen simplex chronicus r) Lymphocytoma cutis s) Molluscum contagiosum t) Mucocele u) My xoid cyst v) Nevi including epiderm al type w) Porokeratosis of Mibelli x) Porokeratosis plantaris discreta y) Prurigo nodularis z) Psoriatic plaques aa)Pyogenic granuloma bb)Rosacea
Drake et al. 649 cc) Sebaceous hyperplasia dd)Seborrheic keratosis ee) Steatocystoma multiplex Jf) Syringoma gg) Trichiasis hh)Venous lake ii) Verrucae (Bowenoid papulosis, condyloma acuminatum, periungual verruca, verruca plana, verruca palmaris et plantaris, verr uca vulgaris jj) Other 2. Precancerous lesions or tumors ofuncertain behavior a) Actinic cheilitis b) Actinic keratoses c) Keratoacanthoma d) Lentigo maligna e) Leukoplakia f) Other 3. Malignant lesions (see Section III. B.) a) Basal cell carcinoma b) Bowen's disease (carcinoma in situ) c) Kaposi's sarcoma d) Metastatic melanoma (palliative only) e) Squamous cell carcinoma I) Actinic keratosis with squamous cell carcinoma 2) Adenoid squamous cell carcinoma 3) De novo squamous cell carcinoma j) Other 4. Miscellaneous Although not widely used, small plaques of psoriasis, lichen simplex chronicus, and hypertrophic lichen planus may be erradicated by full-thickness epidermal freezing (10 to 15 seconds of spray with liquid nitrogen). However, superficial freezing may irritate and produce a Koebner response and is not generally recommended for these inflammatory conditions. B. Issue Cryosurgery is a cost-effective, efficacious, and aesthetically acceptable modality of therapy for a wide variety of skin disorders. Cryosurgery is particularly useful in patients receiving anticoagulants, those allergic to local anesthetics, and those who have pacemakers. There are multiple ways of freezing the skin. Knowledge of the cryogen, the method of application, and the general depth of the disease process is important. Cryosurgery, especially in the treatment of malignant lesions, requires an experienced physician. Physician qualifications include the following:
1. General a) Completed residency training or board
650
Drake et al.
certified in appropriate specialty such as dermatology b) Knowledge of the skin and subcutaneous tissues c) Knowledge of the management of potential complications d) Knowledge of appropriate anesthesia techniques 2. Specific a) The physician should have had training in cryosurgery in residency; or b) Attendance at an appropriate cryosurgery course or preceptorship, which may include video or live surgery demonstrations. c) All physicians performing cryosurgery should have experience at the surgical table under the supervision of a ph ysician experienced in this technique. IV. Diagnostic criteria A. Clinical 1. History may include the following: a) General medical condition b) Previous treatment c) Primary or recurrent lesion d) Cold intolerance If extensive cryosurgery is anticipated, then particular attention should be given to excluding cold intolerance. e) Cold urticaria .f) Degree of skin pigmentation g) Immunosuppression h) Other 2. Appropriate physical examination may include the following: a) Observation of the skin color and appearance b) Previous treatment sites c) Lesion characteristics d) Type and characteristics 1) Type and characteristics 2) Size 3) Location 4) Assessment of the lesion margins 5) Degree of penetration 6) Estimation of biologic aggressiveness of lesion 7) Approximation to superficial nerves, e.g., ulnar nerve at elbow or nerves along sides of digits B. Diagnostic tests 1. Laboratory data may be indicated on the basis of the patient's history. 2. Biopsies may be performed to confirm diagnosis and, when indicated, the depth of the lesion to be treated.
Journal of the American Academy of Dermatology October 1994
3. X-ray, ultrasound, magnetic resonance imaging, or other imaging techniques may be indicated in selected cases. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical (See "Guidelines of Care for Office Surgical Facilities, Parts I and II" [J AMAcAD DERMATOL 1992;26:763-5 (Part I); Part II in press]) a) Anesthesia Local anesthesia is optional before cryosurgery but is often used before treatment of malignant lesions. b) Biopsy The need for biopsy is dependent on the differential diagnosis. It may be obtained at any time before cryosurgical treatment. A posttreatment biopsy is optional depending on the lesion treated. Frozen section biopsy may also be obtained. c) Protection Protection of vital areas may utilize various modalities, but metal devices should be avoided. Areas requiring special attention for protection include the following: 1) Eyes (e.g., plasticretractor(Jaeger), goggles, tongue blade) 2) Nares (e.g., cotton, tongue blade, Styrofoam) 3) Ears (e.g., cotton in canal, gauze padding, tongue blade, polystyrene plastic [Styrofoam]) 4) Other d) Cryogens 1) Liquid nitrogen: presently the cryogen of choice for malignant lesions 2) Solidified carbon diox ide 3) Nitrous oxide 4) Freons 5) Helium e) Temperature monitoring Devices and techniques may be useful in selected lesions or extensive cryosurgical procedures. 1) Clinical assessment by visual evaluation, palpation, and/or ballottement
Journal of the American Academy of Dermatology Volume 31, Number 4
2) Timing (TFT, HIT, TIT) Total freeze time (TFr), halo thaw time (HIT), thermocouple thaw time or total thaw time (TTT), are useful indicators of adequacy of freeze. 3) Measurement of tissue temperature at the edge or depth of the lesion requires a pyrometer and thermocouple needle. 4) Other 17 Sterile technique 1) Cryosurgery in general is not a sterile or aseptic modality of treatment. 2) Appropriate sterile or aseptic technique is recommended for placement of thermocouple needles or other intrusive devices. 3) Appropriate procedures are recommended to ensure the sterility or cleanliness of other instruments and cryogenic agents that are used during the procedure and that may be contaminated. g) Surgical setting 1) Cryosurgery is usually performed in a physician's office, but can be performed in an ambulatory surgical center, outpatient surgery department, or nursing home. 2) The office setting is most common because it is convenient for the patient and physician, decreases the risk of nosocomial infection, and is most economical. h) Materials and equipment may include the following: 1) General: For biopsy or debulking tumor may need the following: (a) Curette, scissors, punch, scalpel or razor blade , electrosurgical unit (b) Hemostatic agents (e) Suture material and surgical instruments (d) Other 2) Specific (a) Cryogenic agent (b) Cotton swabs (c) Styrofoam or stainless steel cups to hold liquid nitrogen and prevent contamination of storage tank or thermos when cotton swab used (d) Cryosurgical unit (e) Accessories including variously
Drake et al. 651 sized spray tips, needles, probes, neoprene cones, otoscope cones, and thermocouple monitoring device fj) Storage tank for cryogen (g) Other i) Methods of application 1) Benign lesions (a) Cotton-tipped. applicator (b) Open-spray (e) Open-cone (confined spray) (d) Closed-cone (e) Cryoprobe (f) Metal applicator (g) Other 2) Malignant lesions (a) Open-spray (b) Open-cone (confined spray) (e) Closed cone (d) Cryoprobe (e) Other j) Procedures 1) Benign lesions (a) Freeze/thaw cycles A single freeze/thaw cycle is typically used but may be repeated for certain conditions or lesions. (b) Clinical monitoring (1) Freeze time varies from 3 to 60 seconds. (2) Visual inspection and/or palpation (3) Measurement of the lateral spread of freeze is optional. (4) Measurement of thaw time is optional. 2) Premalignant lesions (a) Freeze/thaw cycles A single or double freeze/thaw cycle is usual, depending on the type and thickness of the lesion. (b) Clinical monitoring (1) Freeze time and lateral spread of freeze depends on the lesion and location. (2) Visual assessment of freezing is the usual technique for determining adequacy of freeze. (3) Palpation is optional. (4) Measurement of thaw time is optional. (c) Instrument monitoring This is used for certain conditions . If utilized, tissue tempera-
652
Drake et al. ture should be between -25 0 and -50 0 C. 3) Malignant lesions (a) Freeze-thaw cycles (1) A single or double freeze/ thaw cycle is usual. (2) A triple freeze/thaw cycle may be indicated. (b) Clinical monitoring (1) Freeze time varies but is usually 30 to 60 seconds with the use of liquid nitrogen for a I em lesion. Larger lesions may require longer freezing times. (2) Lateral spread of freeze is usually 3 to 5 mm or more. (3) Visual assessment of freezing is a useful technique for determining adequacy of freeze. (4) Halo thaw time may be recorded. (5) Palpation is optional. (c) Monitoring equipment Measurement of tissue temperature is useful, especially for deeper tumors and those in critical locations. It is especially valuable when teaching the technique. When utilized, the preferred range is now between -40 0 and -60 0 C. (d) Debulking the lesion, although optional, is particularly useful for thicker and elevated lesions. (e) Thaw time measurement indicates adequacy of freeze. (fJ Other k) Postoperative care For simple and noncomplex lesions, no specific care other than washing with soap and water is needed. For malignancies and deeper lesions, various combinations of care are optional and may include the following: (1) Washing treated site with soap and water (2) Application of alcohol or hydrogen peroxide to eschar (3) Wet compresses (4) Systemic steroids (rarely, as an antiinflammatory agent for lesions around the eyes in selected cases)
Journal of the American Academy of Dermatology October 1994
(5) Systemic antibiotics (rarely needed but may be used prophylactically in patients with certain medical conditions) (6) Antibiotic ophthalmic solution (7) Drainage of vesicles (8) Keeping treated site clean (9) Gauze dressing (often not necessary) (10) Other I) Other (1) Usual and expected postoperative tissue response varies in degree but may include the following: (a) Pain (b) Tenderness (c) Erythema, local edema, exudation, and crusting (d) Vesicles or bullae including hemorrhagic bullae (e) Sloughing of necrotic tissue (fJ Eschar formation (g) Other (2) Occasional temporary postoperative occurrences (a) Local or more generalized edema, especially periorbital (b) Early hemorrhage .(c) Delayed hemorrhage (d) Syncope (e) Pain and tenderness (f) Nail dystrophy (g) Hypertrophic scarring (h) Infection (i) Nerve injury (rare) (j) Milia (k) Hyperpigrnentation or hypopigmentation (I) Febrile response (rare) (m) Other (3) Permanent postoperative complications (a) I-Iypopigmentation (b) Retraction or scarring (1) Atrophic (2) Hypertrophic (c) Tissue defects (1) Notching of the ear (2) Notching of ala of nose (d) Recurrence of lesion (e) Alopecia {fJ Nail dystrophy (rare) (g) Other B. Miscellaneous Not applicable
Journal of the American Academyof Dermatology Volume 31, Number 4
VI. Supporting evidence See Bibliography (Appendix). VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Further, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice in countries outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
Appendix. Bibliography Breitbart EW. Cryosurgery in the treatment of cutaneous malignant melanoma. Clin DermatoI1990;8:96-100. Boulier J, Myskowsld P, Torre D. Disposable attachment in cryosurgery: a usefuladjunct in the treatment of HIV-associated neoplasms. J Dermatol Surg Oncol1991;17:277-8. Dawber RPR. Cryosurgery: complications and contraindications, Clin DermatoI1990;8:108-14. Drake LA, Ceilley RI, Cornelison RL, et al. Guidelines of care for office surgical facilities. Part 1. J AMACAD DERMATOL 1992;26:763-5. Drake LA, Dorner W, Goltz RW, et al. Guidelines ofcare for officesurgical facilities. Part II. JAM ACAD DERMATOL (In press.) Elton RF. Complications of cutaneouscryosurgery. J AM ACAD DERMATOL 1983;8:513-9. GageAA. Cryotherapyfororalcancer.JAMA 1968;204:565-9. Gage AA. Cryosurgeryfor difficult problems incutaneouscancer. Cutis 1975;16:465-70. Gage AA. Cryosurgery of advanced tumors. Clin Dermatol 1990;8:86-95. Gage AA. Cryosurgeryin the treatment of cancer.Surg Gynecol Obstet 1992;174:73-92. Goldman L. Cryosurgery and laser surgery for Kaposi's sarcoma. Schoch Letter 39. 1989; item 183:43. Graham GF. Cryosurgery for benign, premalignant, and malignant lesions. In: Wheeland RG, ed. Cutaneous surgery. Philadelphia: WB Saunders, 1994:835-69. Graham GF, Clark LC. Statistical analysis in cryosurgeryof skin cancer. Clin DermatoI1990;8:101-7. Graham GF, Stewart R. Cryosurgery for unusual cutaneous neoplasms. J Dermatol Surg Oncol1977;3:437-42. Graham GF. Cryosurgeryfor acne. In: Zacarian SA, ed. Cryosurgery for skin cancer and cutaneous disorders. St Louis: CV Mosby, 1985:
Drake et al. 653 Holt PJA. Cryotherapy for skin cancer: results over a 5 year period usingliquidnitrogen spray cryosurgery. Br J DermatoI1988;119:231-40. JonesSK, Darville JM. Transmissionof virus particlesby cryotherapy and multi-usecaustic pencils: A problemto dermatologists? Br J Dermatol1989;121 :481-6. KufiikAS, Schwartz RA. Lymphocytoma cutis:a seriesof five patients successfully treated with cryosurgery. J AM ACAD DERMATOL 1992;26:449-52. Kuflik EG. Cryosurgical treatment of cutaneous lesions. In: Roenigk RK, Roenigk HH Jr, eds. Dermatologicsurgery: principles andpractice.New York:Marcel Dekker,1989:21939. Kuflik EG. Specific indications for cryosurgeryof the nail unit: myxoidcysts and periungualverrucae. J DermatolSurg Oncol 1992;18:702-6. Kuflik EG, Gage AA. Cryosurgical treatment for skincancer. New York: Igaku-Shoin, 1990. Kuflik: EO, Gage AA. The five-year cure rate achieved by cryosurgery for skin cancer. J AM ACAD DERMATOL 1991;24:1002-4. Kuflik: EG, Lubritz RR, Torre D. Cryosurgery. Clin Dermatol 1984;2:319-32. Lubritz RR. Cryosurgical management of multipleskin carcinomas. J Dermatol Surg OncoI1977 ;3:416-6. Siwiec ED. Treatment ofcryosurgery in the pre-malignantand benign lesions of the skin. Clin Dermatol 1990;8:69-79. SpillerWF, Spiller RF. Treatment of basal-cellcarcinomas by a combination ofcurettage and cryosurgery,J DermatolSurg Oncol 1977;3:443-7. Stewart RB, Graham GF. Cryo corner; a complication of cryosurgery in a patient with cryofibrinogenemia. J Dermatol Surg Oneal 1978;4:743-5. Tappero JW, Bergen TG, Kaplan LD, et aI. Cryotherapyfor cutaneous Kaposi's sarcoma (KS) associated with acquired immune deficiency syndrome (AIDS): a phase II trial. J Acquir Immune DeficSyndr 1991;4:839-46. Torre D. Cryosurgery of basal cell carcinoma. J AM ACAD DERMATOL 1986;15:917-29. Torre D. Cryosurgical instrumentation and depth dose monitoring. Clin Dermatol 1990;8:48-60. Torre D. New York, cradle of cryosurgery. N Y State J Med 1967;67:465-7. Torre D, Lubritz RR, Kufiik EG. Practical cutaneouscryosurgery. Norwalk, Conn: Appleton & Lange, 1988. Zacarian SA. Cryosurgery of cutaneous carcinomas. J AM ACAD DERMATOL 1983;9:947-56. Zacarian SA, ed. Cryosurgery for skin cancer and cutaneous disorders.St Louis: CV Mosby, 1985. Zacarian SA. Cryosurgery in the treatment of skin cancer. In: Friedman RJ, Rigel DS, Kopf AW, eds. Cancer in the skin. Philadelphia: WB Saunders, 1991:451-65. Zacarian SA. Cryosurgical treatment of lentigo maligna, Arch DermatolI982;118 :89-92. Zacarian SA, Adham HI. Cryotherapy of cutaneous malignancy. Cryobiology 1966;2:212-8. Zouboulis CC, Blume V, Buttner P, et al. Outcomes of cryosurgery in keloids and hypertrophic scars: a prospective consecutive trial of case series. Arch Dermatol 1993; 129:1146-51.
Drake et al. dosage forms of oral methoxsalen in psoralens plus ultraviolet A therapy of psoriasis. J AM ACAD DERMATOL 1987; 16:994-8. Morison WL. Phototherapy and photochemotherapy of skin disease. New York: Raven Press, 1991. Morison WL, Momtaz K, Mosher DB, et al. UVB phototherapy in the prophylaxis of polymorphous light eruption. Br J DermatoI1982;106:231-3. Morison WL, Parrish J, Fitzpatrick TB. Oral psoralen photochemotherapy of atopic eczema. Br 1 Dermatol 1978;98:2530. N yfors A, Dahl-N yfors B, Hopwood D. Liver biopsies from patients with psoriasis related to photochemotherapy (PUVA): findings before and after 1 year of therapy in twelve patients. lAM ACAD DERMATOL 1986;14:43-8. Ortonne JP, Mosher DB, Fitzpatrick TB. Vitiligo and other hypomelanoses of hair and skin. New York: Plenum Medical, 1983:260-86. Parrish lA, Chylack LT, Woehler ME, et al. Dermatological and ocular examinations in rabbits chronically photosensitized with methoxsalen. J Invest Dermatol 1979;73: 250-5. Parrish lA, Fitzpatrick TB, Tanenbaum L, et al. Photochemotherapy of psoriasis with oral methoxsalen and longwave ultraviolet light. N Engl 1 Med 1974;291 :1207-1l. Picascia DD, Rothe M, Goldberg NS, et al. Antinuclear antibodies during psoralens plus ultraviolet A (PUVA) thera-
py-Are they worthwhile? JAM ACADDERMATOL 1987; 16:574-7. Prystowsky Jl-l, Keen MS, DeLeo VA. Measurement of the transmittance of ultraviolet and visibleradiation through human eyelids. Photochem Photobiol 1990;51:38. Ramsay CA. Solar urticaria treatment by inducing tolerance to artificial radiation and natural light. Arch Dermatol 1977;113:1222-5. Ros AM. PUVA therapy for erythropoietic protoporphyria. Photodermatology 1988;5:148-9. Saltzer EI. Relief from uremic pruritus: a therapeutic approach. Cutis 1975;16:298-9. Stern RS, Kleinerman RA, Parrish lA, et al. Phototoxic reactions to photoactive drugs in patients treated with PUVA. Arch Dermatol 1980;116:1269-71. Stern RS, Morison WL, Thibodeau LA, et al. Antinuclear antibodies and oral methoxsalen photochemotherapy (PUVA) for psoriasis. Arch DermatoI1979;115:1320-4. Stern RS, Parrish lA, Fitzpatrick TB. Ocular findings in patients treated withPUVA. J Invest Derrnatol 1985;85:26973. Tuffanelli DL. Antinuclear antibodies and photosensitivity in lupus erythematosus-Relevant in PUVA therapy? [Editorial] JAM ACAD DERMATOL 1987;16:614-6. Zachariae H, Kragballe K, Sogaard H. Liver biopsy in PUVAtreated patients. Acta Derm Venereol (Stockh) 1979;59:26870.
This report reflects the best data available at the time the report was prepared, but caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for cryosurgery Committee on Guidelines of Care: Lynn A. Drake, MD, Chairman, Roger I. Ceilley, MD, Raymond L. Cornelison, MD, William L. Dobes, MD, William Dorner, MD, Robert W. Goltz, MD, Charles W. Lewis, MD, Stuart 1. Salasche, MD, Maria L. Chanco Turner, MD, and Barbara J. Lowery, MPH Task Force on Cryosurgery: Gloria F. Graham, MD, Chairman, Richard L. DetIefs, MD, Algin B. Garrett, MD, Emanuel G. Kuflik, MD, and Ronald R. Lubritz, MD I. Introduction The American Academy of Dermatology's Committee on Guidelines of Care is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession Reprint requests: American Academy of Dermatology, P.O. Box4014, Schaumburg, IL 60168·4014. JAM ACAD DERMAToL 1994;31:648-53. Copyright © 1994 by the American Academy of Dermatology, Inc. 0190-9622/94 $3.00
648
+ 0 16/1/57562
in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice in countries outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
II. Definition Cryosurgery is a procedure utilizing cryogenic agents to treat a variety of cutaneous diseases. Freezing temperatures of a cryogenic agent applied directly or indirectly to the skin cause local destruc-
Journal of the American Academy of Dermatology Volume 31, Number 4
tion of tissue. Certain conditions may require multiple or repeated treatments. Cryotherapy, a term used for many years, is best reserved for more superficial forms of freezing. This guidelineprimarily addresses the scope of cryosurgery. III. Rationale A . Scope Millions of people are affected annually by a wide variety of cutaneous and mucocutaneous disorders for which cryosurgery can be an effective treatment. A variety of benign lesions develop in children, teenagers , and adults. In addition, premalignant dermatoses, premalignant tumors, and malignant tumors develop with increasing age, many related to exposure to UV radiation. Single or multiple lesions on all areas of the body can be eradicated with cryosurgery. These cryosurgery guidelines identify appropriate care, expectations, morbidity, and complications. The following are some conditions that may be amenable to cryosurgery: 1. Benign lesions a) Acne vulgaris, cystic b) Angiolymphoid hyperplasia c) Angiokeratoma-Fordyce and solitary type d) Angioma, cherry and spider e) Chondrodermatitis nodularis chronicus helicis j) Dermatofibroma g) Disseminated superficial actinic porokeratosis h) Granuloma faciale i) Granuloma fissuratum j) Hemangioma, strawberry and cavernous k) Hidradenitis suppurativa /) Keloid m) Leishmaniasis n) Lentigines, lentigo simplex, solar lentigo 0) Lichen planus, hypertrophic form p) Lichen sclerosus et atrophicus q) Lichen simplex chronicus r) Lymphocytoma cutis s) Molluscum contagiosum t) Mucocele u) My xoid cyst v) Nevi including epiderm al type w) Porokeratosis of Mibelli x) Porokeratosis plantaris discreta y) Prurigo nodularis z) Psoriatic plaques aa)Pyogenic granuloma bb)Rosacea
Drake et al. 649 cc) Sebaceous hyperplasia dd)Seborrheic keratosis ee) Steatocystoma multiplex Jf) Syringoma gg) Trichiasis hh)Venous lake ii) Verrucae (Bowenoid papulosis, condyloma acuminatum, periungual verruca, verruca plana, verruca palmaris et plantaris, verr uca vulgaris jj) Other 2. Precancerous lesions or tumors ofuncertain behavior a) Actinic cheilitis b) Actinic keratoses c) Keratoacanthoma d) Lentigo maligna e) Leukoplakia f) Other 3. Malignant lesions (see Section III. B.) a) Basal cell carcinoma b) Bowen's disease (carcinoma in situ) c) Kaposi's sarcoma d) Metastatic melanoma (palliative only) e) Squamous cell carcinoma I) Actinic keratosis with squamous cell carcinoma 2) Adenoid squamous cell carcinoma 3) De novo squamous cell carcinoma j) Other 4. Miscellaneous Although not widely used, small plaques of psoriasis, lichen simplex chronicus, and hypertrophic lichen planus may be erradicated by full-thickness epidermal freezing (10 to 15 seconds of spray with liquid nitrogen). However, superficial freezing may irritate and produce a Koebner response and is not generally recommended for these inflammatory conditions. B. Issue Cryosurgery is a cost-effective, efficacious, and aesthetically acceptable modality of therapy for a wide variety of skin disorders. Cryosurgery is particularly useful in patients receiving anticoagulants, those allergic to local anesthetics, and those who have pacemakers. There are multiple ways of freezing the skin. Knowledge of the cryogen, the method of application, and the general depth of the disease process is important. Cryosurgery, especially in the treatment of malignant lesions, requires an experienced physician. Physician qualifications include the following:
1. General a) Completed residency training or board
650
Drake et al.
certified in appropriate specialty such as dermatology b) Knowledge of the skin and subcutaneous tissues c) Knowledge of the management of potential complications d) Knowledge of appropriate anesthesia techniques 2. Specific a) The physician should have had training in cryosurgery in residency; or b) Attendance at an appropriate cryosurgery course or preceptorship, which may include video or live surgery demonstrations. c) All physicians performing cryosurgery should have experience at the surgical table under the supervision of a ph ysician experienced in this technique. IV. Diagnostic criteria A. Clinical 1. History may include the following: a) General medical condition b) Previous treatment c) Primary or recurrent lesion d) Cold intolerance If extensive cryosurgery is anticipated, then particular attention should be given to excluding cold intolerance. e) Cold urticaria .f) Degree of skin pigmentation g) Immunosuppression h) Other 2. Appropriate physical examination may include the following: a) Observation of the skin color and appearance b) Previous treatment sites c) Lesion characteristics d) Type and characteristics 1) Type and characteristics 2) Size 3) Location 4) Assessment of the lesion margins 5) Degree of penetration 6) Estimation of biologic aggressiveness of lesion 7) Approximation to superficial nerves, e.g., ulnar nerve at elbow or nerves along sides of digits B. Diagnostic tests 1. Laboratory data may be indicated on the basis of the patient's history. 2. Biopsies may be performed to confirm diagnosis and, when indicated, the depth of the lesion to be treated.
Journal of the American Academy of Dermatology October 1994
3. X-ray, ultrasound, magnetic resonance imaging, or other imaging techniques may be indicated in selected cases. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical (See "Guidelines of Care for Office Surgical Facilities, Parts I and II" [J AMAcAD DERMATOL 1992;26:763-5 (Part I); Part II in press]) a) Anesthesia Local anesthesia is optional before cryosurgery but is often used before treatment of malignant lesions. b) Biopsy The need for biopsy is dependent on the differential diagnosis. It may be obtained at any time before cryosurgical treatment. A posttreatment biopsy is optional depending on the lesion treated. Frozen section biopsy may also be obtained. c) Protection Protection of vital areas may utilize various modalities, but metal devices should be avoided. Areas requiring special attention for protection include the following: 1) Eyes (e.g., plasticretractor(Jaeger), goggles, tongue blade) 2) Nares (e.g., cotton, tongue blade, Styrofoam) 3) Ears (e.g., cotton in canal, gauze padding, tongue blade, polystyrene plastic [Styrofoam]) 4) Other d) Cryogens 1) Liquid nitrogen: presently the cryogen of choice for malignant lesions 2) Solidified carbon diox ide 3) Nitrous oxide 4) Freons 5) Helium e) Temperature monitoring Devices and techniques may be useful in selected lesions or extensive cryosurgical procedures. 1) Clinical assessment by visual evaluation, palpation, and/or ballottement
Journal of the American Academy of Dermatology Volume 31, Number 4
2) Timing (TFT, HIT, TIT) Total freeze time (TFr), halo thaw time (HIT), thermocouple thaw time or total thaw time (TTT), are useful indicators of adequacy of freeze. 3) Measurement of tissue temperature at the edge or depth of the lesion requires a pyrometer and thermocouple needle. 4) Other 17 Sterile technique 1) Cryosurgery in general is not a sterile or aseptic modality of treatment. 2) Appropriate sterile or aseptic technique is recommended for placement of thermocouple needles or other intrusive devices. 3) Appropriate procedures are recommended to ensure the sterility or cleanliness of other instruments and cryogenic agents that are used during the procedure and that may be contaminated. g) Surgical setting 1) Cryosurgery is usually performed in a physician's office, but can be performed in an ambulatory surgical center, outpatient surgery department, or nursing home. 2) The office setting is most common because it is convenient for the patient and physician, decreases the risk of nosocomial infection, and is most economical. h) Materials and equipment may include the following: 1) General: For biopsy or debulking tumor may need the following: (a) Curette, scissors, punch, scalpel or razor blade , electrosurgical unit (b) Hemostatic agents (e) Suture material and surgical instruments (d) Other 2) Specific (a) Cryogenic agent (b) Cotton swabs (c) Styrofoam or stainless steel cups to hold liquid nitrogen and prevent contamination of storage tank or thermos when cotton swab used (d) Cryosurgical unit (e) Accessories including variously
Drake et al. 651 sized spray tips, needles, probes, neoprene cones, otoscope cones, and thermocouple monitoring device fj) Storage tank for cryogen (g) Other i) Methods of application 1) Benign lesions (a) Cotton-tipped. applicator (b) Open-spray (e) Open-cone (confined spray) (d) Closed-cone (e) Cryoprobe (f) Metal applicator (g) Other 2) Malignant lesions (a) Open-spray (b) Open-cone (confined spray) (e) Closed cone (d) Cryoprobe (e) Other j) Procedures 1) Benign lesions (a) Freeze/thaw cycles A single freeze/thaw cycle is typically used but may be repeated for certain conditions or lesions. (b) Clinical monitoring (1) Freeze time varies from 3 to 60 seconds. (2) Visual inspection and/or palpation (3) Measurement of the lateral spread of freeze is optional. (4) Measurement of thaw time is optional. 2) Premalignant lesions (a) Freeze/thaw cycles A single or double freeze/thaw cycle is usual, depending on the type and thickness of the lesion. (b) Clinical monitoring (1) Freeze time and lateral spread of freeze depends on the lesion and location. (2) Visual assessment of freezing is the usual technique for determining adequacy of freeze. (3) Palpation is optional. (4) Measurement of thaw time is optional. (c) Instrument monitoring This is used for certain conditions . If utilized, tissue tempera-
652
Drake et al. ture should be between -25 0 and -50 0 C. 3) Malignant lesions (a) Freeze-thaw cycles (1) A single or double freeze/ thaw cycle is usual. (2) A triple freeze/thaw cycle may be indicated. (b) Clinical monitoring (1) Freeze time varies but is usually 30 to 60 seconds with the use of liquid nitrogen for a I em lesion. Larger lesions may require longer freezing times. (2) Lateral spread of freeze is usually 3 to 5 mm or more. (3) Visual assessment of freezing is a useful technique for determining adequacy of freeze. (4) Halo thaw time may be recorded. (5) Palpation is optional. (c) Monitoring equipment Measurement of tissue temperature is useful, especially for deeper tumors and those in critical locations. It is especially valuable when teaching the technique. When utilized, the preferred range is now between -40 0 and -60 0 C. (d) Debulking the lesion, although optional, is particularly useful for thicker and elevated lesions. (e) Thaw time measurement indicates adequacy of freeze. (fJ Other k) Postoperative care For simple and noncomplex lesions, no specific care other than washing with soap and water is needed. For malignancies and deeper lesions, various combinations of care are optional and may include the following: (1) Washing treated site with soap and water (2) Application of alcohol or hydrogen peroxide to eschar (3) Wet compresses (4) Systemic steroids (rarely, as an antiinflammatory agent for lesions around the eyes in selected cases)
Journal of the American Academy of Dermatology October 1994
(5) Systemic antibiotics (rarely needed but may be used prophylactically in patients with certain medical conditions) (6) Antibiotic ophthalmic solution (7) Drainage of vesicles (8) Keeping treated site clean (9) Gauze dressing (often not necessary) (10) Other I) Other (1) Usual and expected postoperative tissue response varies in degree but may include the following: (a) Pain (b) Tenderness (c) Erythema, local edema, exudation, and crusting (d) Vesicles or bullae including hemorrhagic bullae (e) Sloughing of necrotic tissue (fJ Eschar formation (g) Other (2) Occasional temporary postoperative occurrences (a) Local or more generalized edema, especially periorbital (b) Early hemorrhage .(c) Delayed hemorrhage (d) Syncope (e) Pain and tenderness (f) Nail dystrophy (g) Hypertrophic scarring (h) Infection (i) Nerve injury (rare) (j) Milia (k) Hyperpigrnentation or hypopigmentation (I) Febrile response (rare) (m) Other (3) Permanent postoperative complications (a) I-Iypopigmentation (b) Retraction or scarring (1) Atrophic (2) Hypertrophic (c) Tissue defects (1) Notching of the ear (2) Notching of ala of nose (d) Recurrence of lesion (e) Alopecia {fJ Nail dystrophy (rare) (g) Other B. Miscellaneous Not applicable
Journal of the American Academyof Dermatology Volume 31, Number 4
VI. Supporting evidence See Bibliography (Appendix). VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Further, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice in countries outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
Appendix. Bibliography Breitbart EW. Cryosurgery in the treatment of cutaneous malignant melanoma. Clin DermatoI1990;8:96-100. Boulier J, Myskowsld P, Torre D. Disposable attachment in cryosurgery: a usefuladjunct in the treatment of HIV-associated neoplasms. J Dermatol Surg Oncol1991;17:277-8. Dawber RPR. Cryosurgery: complications and contraindications, Clin DermatoI1990;8:108-14. Drake LA, Ceilley RI, Cornelison RL, et al. Guidelines of care for office surgical facilities. Part 1. J AMACAD DERMATOL 1992;26:763-5. Drake LA, Dorner W, Goltz RW, et al. Guidelines ofcare for officesurgical facilities. Part II. JAM ACAD DERMATOL (In press.) Elton RF. Complications of cutaneouscryosurgery. J AM ACAD DERMATOL 1983;8:513-9. GageAA. Cryotherapyfororalcancer.JAMA 1968;204:565-9. Gage AA. Cryosurgeryfor difficult problems incutaneouscancer. Cutis 1975;16:465-70. Gage AA. Cryosurgery of advanced tumors. Clin Dermatol 1990;8:86-95. Gage AA. Cryosurgeryin the treatment of cancer.Surg Gynecol Obstet 1992;174:73-92. Goldman L. Cryosurgery and laser surgery for Kaposi's sarcoma. Schoch Letter 39. 1989; item 183:43. Graham GF. Cryosurgery for benign, premalignant, and malignant lesions. In: Wheeland RG, ed. Cutaneous surgery. Philadelphia: WB Saunders, 1994:835-69. Graham GF, Clark LC. Statistical analysis in cryosurgeryof skin cancer. Clin DermatoI1990;8:101-7. Graham GF, Stewart R. Cryosurgery for unusual cutaneous neoplasms. J Dermatol Surg Oncol1977;3:437-42. Graham GF. Cryosurgeryfor acne. In: Zacarian SA, ed. Cryosurgery for skin cancer and cutaneous disorders. St Louis: CV Mosby, 1985:
Drake et al. 653 Holt PJA. Cryotherapy for skin cancer: results over a 5 year period usingliquidnitrogen spray cryosurgery. Br J DermatoI1988;119:231-40. JonesSK, Darville JM. Transmissionof virus particlesby cryotherapy and multi-usecaustic pencils: A problemto dermatologists? Br J Dermatol1989;121 :481-6. KufiikAS, Schwartz RA. Lymphocytoma cutis:a seriesof five patients successfully treated with cryosurgery. J AM ACAD DERMATOL 1992;26:449-52. Kuflik EG. Cryosurgical treatment of cutaneous lesions. In: Roenigk RK, Roenigk HH Jr, eds. Dermatologicsurgery: principles andpractice.New York:Marcel Dekker,1989:21939. Kuflik EG. Specific indications for cryosurgeryof the nail unit: myxoidcysts and periungualverrucae. J DermatolSurg Oncol 1992;18:702-6. Kuflik EG, Gage AA. Cryosurgical treatment for skincancer. New York: Igaku-Shoin, 1990. Kuflik: EO, Gage AA. The five-year cure rate achieved by cryosurgery for skin cancer. J AM ACAD DERMATOL 1991;24:1002-4. Kuflik: EG, Lubritz RR, Torre D. Cryosurgery. Clin Dermatol 1984;2:319-32. Lubritz RR. Cryosurgical management of multipleskin carcinomas. J Dermatol Surg OncoI1977 ;3:416-6. Siwiec ED. Treatment ofcryosurgery in the pre-malignantand benign lesions of the skin. Clin Dermatol 1990;8:69-79. SpillerWF, Spiller RF. Treatment of basal-cellcarcinomas by a combination ofcurettage and cryosurgery,J DermatolSurg Oncol 1977;3:443-7. Stewart RB, Graham GF. Cryo corner; a complication of cryosurgery in a patient with cryofibrinogenemia. J Dermatol Surg Oneal 1978;4:743-5. Tappero JW, Bergen TG, Kaplan LD, et aI. Cryotherapyfor cutaneous Kaposi's sarcoma (KS) associated with acquired immune deficiency syndrome (AIDS): a phase II trial. J Acquir Immune DeficSyndr 1991;4:839-46. Torre D. Cryosurgery of basal cell carcinoma. J AM ACAD DERMATOL 1986;15:917-29. Torre D. Cryosurgical instrumentation and depth dose monitoring. Clin Dermatol 1990;8:48-60. Torre D. New York, cradle of cryosurgery. N Y State J Med 1967;67:465-7. Torre D, Lubritz RR, Kufiik EG. Practical cutaneouscryosurgery. Norwalk, Conn: Appleton & Lange, 1988. Zacarian SA. Cryosurgery of cutaneous carcinomas. J AM ACAD DERMATOL 1983;9:947-56. Zacarian SA, ed. Cryosurgery for skin cancer and cutaneous disorders.St Louis: CV Mosby, 1985. Zacarian SA. Cryosurgery in the treatment of skin cancer. In: Friedman RJ, Rigel DS, Kopf AW, eds. Cancer in the skin. Philadelphia: WB Saunders, 1991:451-65. Zacarian SA. Cryosurgical treatment of lentigo maligna, Arch DermatolI982;118 :89-92. Zacarian SA, Adham HI. Cryotherapy of cutaneous malignancy. Cryobiology 1966;2:212-8. Zouboulis CC, Blume V, Buttner P, et al. Outcomes of cryosurgery in keloids and hypertrophic scars: a prospective consecutive trial of case series. Arch Dermatol 1993; 129:1146-51.