PRELIMINARY COMMUNICATION
PERCUTANEOUS TRANSPERINEAL PROSTATE CRYOSURGERY USING TRANSRECTAL ULTRASOUND GUIDANCE: ANIMAL MODEL GARY ONIK, M.D. BARBARA PORTERFIELD, AHT BORIS RUBINSKY, PH.D. JEFFREY COHEN, M.D. From the Department of Radiology, Presbyterian-University Hospital, and Allegheny Hospital, Pittsburgh, Pennsylvania, and Department of Mechanical Engineering, University of California at Berkeley, California
has previously been used successfully to treat prostatic carcinoma. In,zing led to local complications that limited the use of this modality. that monitoring of the freezing process can be accomplished using real~udy, transrectal ultrasound guidance was used to guide a cryoprobe nsperineal approach, into the prostate. The extent o/freezing was then t, taking care not to freeze the urethra or the rectum. Six dogs had the mplications. This study demonstrates the feasibility of a noninvasive cinoma.
ma is recognized as one of the aalignant diseases occurring in .rd treatment for Stages B and noma includes radical surgery erapy. 1 The fact that each of can involve significant mor[ications2 becomes of considerthat transrectal ultrasound is Lg to find prostatic carcinoma ge. Since it has not been esis early detection will make a :tality, particularly taking into bidity of the potentially euraa less dangerous and less invaould be particularly welcome. rostatic cryosurgery, which is o temperatures to destroy disssue, was thought to be a less ve and was shown to have ad:her therapeutic modalities in
/
MARCH 1991
/
treating prostatic carcinoma, particularly in the treatment of patients considered poor surgical risks. 3 Prostatic cryosurgery has been shown to produce a survival equivalent to other treatment modalities, but it has not been widely accepted because of local complications, such as urethrorectal fistula and urethrocutaneous fistulas that occurred due to poorly controlled freezing. 4 Onik et al. ~ have shown the feasibility of monitoring the volume of frozen tissue with real-time ultrasound (US). This technique has been used successfully to monitor cryosurgery of the liverA 7 Recent experimental work has shown that this concept is directly applicable to prostate freezing as well. This fact, coupled with the improvements in transrectal US with its ability to detect small prostatic tumors and guide needle placements into the prostate, has given us the potential to apply cryosurgery to
VOLUME XXXVII, NUMBER 3
277
TEMPERATURE
(
PROBE
-
'
~
CANNULA OVER
TROCAR
TEMPERATURE -- PROBE TROCARE ANDDILATOR
C
¢
D
FIGURE 1. (A) Under transrectal ultrasound guidance trocar with attached wire is placed into Cannula and dilator placed over wire down to tumor. (C) Cannula and dilator are removed. (D) placed through cannula into tumor. the prostate in a noninvasive fashion without the complications previously associated with the modality. The goal of this study was to show that transperineal p e r e u t a n e o u s eryoprobe placement was possible, and with transreetal ultrasound monitoring, cryosurgery could be accomplished without complication. Material and Methods Six dogs were included in this experiment. Under general anesthesia using transreetal ultrasound (Diasonics DR 400) as guidance, an 18-gauge needle with an eehogenie coating and floppy wire attached to its end was placed into the lateral lobe of the dog's prostate. This was done under free hand control since the symphysis pubis in the dog prevented use of a transperineal biopsy guide. Once the needle-wire was confirmed to be in the correct position, a eannula with inner dilator was placed over this wire into the prostate. Once confirmed to be
278
correctly positioned within the wire and the dilator were remc mm eyroprobe was placed throul into the prostate (Fig. 1). The er) tronies, Inc.) was then turned on liquid nitrogen ( - 1 9 6 ° C). Th( freezing was monitored using u] the freezing was continued for five minutes or until the ultrasc that the urethra or the rectum frozen. The freezing was then and the eryoprobe was removec was monitored under ultrasound thawing was noted. After the dog's Foley catheter was remove was monitored until spontaneo curred. One dog was sacrificed the other 5 were monitored for complications and then saerifie examination of the prostate wa out.
UROLOGY
/
MARCH 1991
/
VOLUME
xxxvII,
NUMB&~
Results was successfully performed in freezing was visualized in all yperechoic rim with posterior ing (emanating from the cryond 3). After thawing, the cryoto have markedly decreased mpared with the rest of the This area of decreased echoInded to the limits of the cryoathologic examination of the acrificed immediately. Microion showed complete coagula1in the boundaries of the cryo; consistent with our previous /
MARCH 1991
/
F~GURE 3. Pathologicspecimen showing cryolesion correlating with ultrasound picture.
VOLUME XXXVII, NUMBER 3
279
studies. 7,8 The dogs that were sacrificed at two weeks showed essentially the same findings with minimal inflammatory infiltration. None of the dogs had difficulty urinating after the procedure. All showed mild transient hematuria after the procedure, but no serious complications were noted; specifically, there was no evidence for fistulization to either the rectum or the skin. Comment It is clear that the treatment modalities that are presently available for treating localized prostatic carcinoma have significant shortcomings in terms of complications. Both radical prostateetomy and radiation therapy, preceded by pelvic lymphadeneetomy, can be associated with impotence, thrombophlebitis, lymphoeele formation, incontinence, and edema of the penis and lower extremities?-11 Cryosurgery, the in situ destruction of malignancy by the application of subzero temperatures, is another modality that has been used in the treatment of prostatic carcinoma. Its advantages include its rapidity, its bloodlessness, and its ability to be used in selected eases under local anesthesia. 3 Since it is a focal treatment, it is less likely to produce impotence or incontinence. 4 Prostatic cryosurgery has been used in the poor-risk patient, in patients with hematologic problems, and for those patients with large inoperable prostate carcinomas. Cryosurgery has been shown by Bonney et al. 4 in 229 patients to compare favorably in survival with prostateetomy and external beam radiation therapy. The procedure he used was an open transperineal approach with visual monitoring of the prostate freezing. This, consequently, made it difficult to visualize the freezing in relationship to the rectum and urethra, as well as the margins of the tumor. The major complications associated with the cryosurgery, which included urethroreetal fistula in 1.4 percent and urethroeutaneous fistula in 10.7 percent of patients, was directly related to this inability to m o n i t o r the f r e e z i n g process. Impotence, however, was seen in only 7.4 percent of patients. External real-time ultrasound monitoring of eryoprostateetomy was an improvement in eryosurgieal technique. 12 In 87 transperineal surgical procedures monitored in this manner, no local complications occurred. 10 This study dearly shows that transreetal ultrasound can be used to monitor prostatic cryosurgery. In all animals were were able to successfully place pereutaneously a eryoprobe under
280
transreetal ultrasound guidan tions were associated with th~ should be noted, because of tlq of the dog, that we had to u placement and therefore eoul, tage of the presently availa biopsy guides. Utilization o: reotaxis could only make the and safer. Not only was placement , possible under ultrasound gl complete freezing process e( successfully. Freezing appear, as a hypereehoie rim emanati: probe. Since sound did not ball, there was posterior aec This limited the visualization teriorly; however, since the fro spherical, the extent of freezi~ lated and estimated. In additJ ultrasound is available which ualization of the ice ball sire another direction, o b v i a t i n g mating the extent of freezing. ization, we were able to suc~ freezing in relationship to the turn, avoiding damage to the plan to add further safety to monitoring the temperature ir a thermocouple connected to These abilities should help ob cations of urethroreetal and fistula that made previous e ceptable. In addition, once tl the normal prostatic tissue th. peared hypoeehoie in compar frozen tissue, leaving a signat the cryosurgieal margin. The early detection and t1 tatie cancer represent a dil course of the disease is variabl fatal. Since the procedures m tive resection are morbid, tt been raised that the early det numbers of cases might ac greater morbidity and morta these tumors untreated.13 Wh~ study is being considered to e: tion, the results of which wo able for approximately ten yea tainly be great pressure on c early tumors found by transrc A minimally invasive treatl have demonstrated with per perineal prostate cryosurgery
UROLOGY
/
M A R C H 1991
/
V O L U M E XXXVII, NU :~;
, would therefore be very ?edure is of low enough t possibly even be done on Since it would not require a conservative approach fly in the extent of freezing cations, with the operation Another major advantage al ultrasound-guided bioptreatment ean easily be lolL1 morbidity. If treatment ~quate, the more invasive be followed. A possible obure is that very often pros3wn to be multifoeal in the ,roeedure, however, it may ylaetieally treat the oppoate gland at the same time procedure with a similar state cryosurgery, which in ~own to successfully treat can now be applied pereuhelp of transreetal ultra:easing number of prostate at early stages by transreeroeedure could play an imlanagemen.t of this patient
/ MARCH
1991
/ VOLUME
XXXVII,
NUMBER
Department of Radiology Presbyterian-University Hospital DeSoto and O'Hara Streets Pittsburgh, Pennsylvania 15213 (DR. O N I K ) References 1. Smith DR: General Urology, East Norwalk, CT, Lange Medical, 1982, p 342. 2. Javadpour N: Recent Advances in Urologic Cancer, Baltimore, Williams and Wilkins, I982, pp 205-206. 3. Addonizio ]: Another look at eryoprostatectomy, Cryobiology 19:223 (1982). 4. Bonney WV¢, et ah Cryosurgery in prostate cancer: survival, Urology 19:37 (1982). 5. Onik G, et al: Ultrasonic characteristics of frozen liver, Cryobiology 21" 321 (1984). 6. Onik G, et ah Sonographic monitoring of hepatic cryosurgery in an experimental animal model, AJR 144:1043 0985). 7. Onik G, et ah Monitoring hepatic cryosurgery with sonography, AJtt 147:665 (1986). 8. Onik G, et al: Ultrasound eharaeteristies of frozen prostate, Radiology 168:629 (1988). 9. Jewett HJ: The present status of radical prostatectomy for Stage A and Stage B prostatic cancer, Urol Clin North Am 2:105 (1975).
10. Whitmore WF Jr, Hilaris B, and Grabstald H: Retropubic implantation of iodine-125 in the treatment of prostatic cancer, J Urol 108:918 0972). l l . Herr HW: Complication of pelvie lymphadeneetomy and retropubie prostatic 1-125 implantation, Urology 14:226 (1979). 12. Ando K: Cryoprostatectomy under control of ultrasonotomography, presented at 14th Congress of International Urologic Society, September, 1982. 13. Van J: Early prostate surgery may not be worth the risk, Chieago Tribune, Sept. I4, 1989, p 1.
3
281
PERCUTANEOUS TRANSPERINEAL PROSTATE CRYOSURGERY USING TRANSRECTAL ULTRASOUND GUIDANCE: ANIMAL MODEL GARY ONIK, M.D. BARBARA PORTERFIELD, AHT BORIS RUBINSKY, PH.D. JEFFREY COHEN, M.D. From the Department of Radiology, Presbyterian-University Hospital, and Allegheny Hospital, Pittsburgh, Pennsylvania, and Department of Mechanical Engineering, University of California at Berkeley, California
has previously been used successfully to treat prostatic carcinoma. In,zing led to local complications that limited the use of this modality. that monitoring of the freezing process can be accomplished using real~udy, transrectal ultrasound guidance was used to guide a cryoprobe nsperineal approach, into the prostate. The extent o/freezing was then t, taking care not to freeze the urethra or the rectum. Six dogs had the mplications. This study demonstrates the feasibility of a noninvasive cinoma.
ma is recognized as one of the aalignant diseases occurring in .rd treatment for Stages B and noma includes radical surgery erapy. 1 The fact that each of can involve significant mor[ications2 becomes of considerthat transrectal ultrasound is Lg to find prostatic carcinoma ge. Since it has not been esis early detection will make a :tality, particularly taking into bidity of the potentially euraa less dangerous and less invaould be particularly welcome. rostatic cryosurgery, which is o temperatures to destroy disssue, was thought to be a less ve and was shown to have ad:her therapeutic modalities in
/
MARCH 1991
/
treating prostatic carcinoma, particularly in the treatment of patients considered poor surgical risks. 3 Prostatic cryosurgery has been shown to produce a survival equivalent to other treatment modalities, but it has not been widely accepted because of local complications, such as urethrorectal fistula and urethrocutaneous fistulas that occurred due to poorly controlled freezing. 4 Onik et al. ~ have shown the feasibility of monitoring the volume of frozen tissue with real-time ultrasound (US). This technique has been used successfully to monitor cryosurgery of the liverA 7 Recent experimental work has shown that this concept is directly applicable to prostate freezing as well. This fact, coupled with the improvements in transrectal US with its ability to detect small prostatic tumors and guide needle placements into the prostate, has given us the potential to apply cryosurgery to
VOLUME XXXVII, NUMBER 3
277
TEMPERATURE
(
PROBE
-
'
~
CANNULA OVER
TROCAR
TEMPERATURE -- PROBE TROCARE ANDDILATOR
C
¢
D
FIGURE 1. (A) Under transrectal ultrasound guidance trocar with attached wire is placed into Cannula and dilator placed over wire down to tumor. (C) Cannula and dilator are removed. (D) placed through cannula into tumor. the prostate in a noninvasive fashion without the complications previously associated with the modality. The goal of this study was to show that transperineal p e r e u t a n e o u s eryoprobe placement was possible, and with transreetal ultrasound monitoring, cryosurgery could be accomplished without complication. Material and Methods Six dogs were included in this experiment. Under general anesthesia using transreetal ultrasound (Diasonics DR 400) as guidance, an 18-gauge needle with an eehogenie coating and floppy wire attached to its end was placed into the lateral lobe of the dog's prostate. This was done under free hand control since the symphysis pubis in the dog prevented use of a transperineal biopsy guide. Once the needle-wire was confirmed to be in the correct position, a eannula with inner dilator was placed over this wire into the prostate. Once confirmed to be
278
correctly positioned within the wire and the dilator were remc mm eyroprobe was placed throul into the prostate (Fig. 1). The er) tronies, Inc.) was then turned on liquid nitrogen ( - 1 9 6 ° C). Th( freezing was monitored using u] the freezing was continued for five minutes or until the ultrasc that the urethra or the rectum frozen. The freezing was then and the eryoprobe was removec was monitored under ultrasound thawing was noted. After the dog's Foley catheter was remove was monitored until spontaneo curred. One dog was sacrificed the other 5 were monitored for complications and then saerifie examination of the prostate wa out.
UROLOGY
/
MARCH 1991
/
VOLUME
xxxvII,
NUMB&~
Results was successfully performed in freezing was visualized in all yperechoic rim with posterior ing (emanating from the cryond 3). After thawing, the cryoto have markedly decreased mpared with the rest of the This area of decreased echoInded to the limits of the cryoathologic examination of the acrificed immediately. Microion showed complete coagula1in the boundaries of the cryo; consistent with our previous /
MARCH 1991
/
F~GURE 3. Pathologicspecimen showing cryolesion correlating with ultrasound picture.
VOLUME XXXVII, NUMBER 3
279
studies. 7,8 The dogs that were sacrificed at two weeks showed essentially the same findings with minimal inflammatory infiltration. None of the dogs had difficulty urinating after the procedure. All showed mild transient hematuria after the procedure, but no serious complications were noted; specifically, there was no evidence for fistulization to either the rectum or the skin. Comment It is clear that the treatment modalities that are presently available for treating localized prostatic carcinoma have significant shortcomings in terms of complications. Both radical prostateetomy and radiation therapy, preceded by pelvic lymphadeneetomy, can be associated with impotence, thrombophlebitis, lymphoeele formation, incontinence, and edema of the penis and lower extremities?-11 Cryosurgery, the in situ destruction of malignancy by the application of subzero temperatures, is another modality that has been used in the treatment of prostatic carcinoma. Its advantages include its rapidity, its bloodlessness, and its ability to be used in selected eases under local anesthesia. 3 Since it is a focal treatment, it is less likely to produce impotence or incontinence. 4 Prostatic cryosurgery has been used in the poor-risk patient, in patients with hematologic problems, and for those patients with large inoperable prostate carcinomas. Cryosurgery has been shown by Bonney et al. 4 in 229 patients to compare favorably in survival with prostateetomy and external beam radiation therapy. The procedure he used was an open transperineal approach with visual monitoring of the prostate freezing. This, consequently, made it difficult to visualize the freezing in relationship to the rectum and urethra, as well as the margins of the tumor. The major complications associated with the cryosurgery, which included urethroreetal fistula in 1.4 percent and urethroeutaneous fistula in 10.7 percent of patients, was directly related to this inability to m o n i t o r the f r e e z i n g process. Impotence, however, was seen in only 7.4 percent of patients. External real-time ultrasound monitoring of eryoprostateetomy was an improvement in eryosurgieal technique. 12 In 87 transperineal surgical procedures monitored in this manner, no local complications occurred. 10 This study dearly shows that transreetal ultrasound can be used to monitor prostatic cryosurgery. In all animals were were able to successfully place pereutaneously a eryoprobe under
280
transreetal ultrasound guidan tions were associated with th~ should be noted, because of tlq of the dog, that we had to u placement and therefore eoul, tage of the presently availa biopsy guides. Utilization o: reotaxis could only make the and safer. Not only was placement , possible under ultrasound gl complete freezing process e( successfully. Freezing appear, as a hypereehoie rim emanati: probe. Since sound did not ball, there was posterior aec This limited the visualization teriorly; however, since the fro spherical, the extent of freezi~ lated and estimated. In additJ ultrasound is available which ualization of the ice ball sire another direction, o b v i a t i n g mating the extent of freezing. ization, we were able to suc~ freezing in relationship to the turn, avoiding damage to the plan to add further safety to monitoring the temperature ir a thermocouple connected to These abilities should help ob cations of urethroreetal and fistula that made previous e ceptable. In addition, once tl the normal prostatic tissue th. peared hypoeehoie in compar frozen tissue, leaving a signat the cryosurgieal margin. The early detection and t1 tatie cancer represent a dil course of the disease is variabl fatal. Since the procedures m tive resection are morbid, tt been raised that the early det numbers of cases might ac greater morbidity and morta these tumors untreated.13 Wh~ study is being considered to e: tion, the results of which wo able for approximately ten yea tainly be great pressure on c early tumors found by transrc A minimally invasive treatl have demonstrated with per perineal prostate cryosurgery
UROLOGY
/
M A R C H 1991
/
V O L U M E XXXVII, NU :~;
, would therefore be very ?edure is of low enough t possibly even be done on Since it would not require a conservative approach fly in the extent of freezing cations, with the operation Another major advantage al ultrasound-guided bioptreatment ean easily be lolL1 morbidity. If treatment ~quate, the more invasive be followed. A possible obure is that very often pros3wn to be multifoeal in the ,roeedure, however, it may ylaetieally treat the oppoate gland at the same time procedure with a similar state cryosurgery, which in ~own to successfully treat can now be applied pereuhelp of transreetal ultra:easing number of prostate at early stages by transreeroeedure could play an imlanagemen.t of this patient
/ MARCH
1991
/ VOLUME
XXXVII,
NUMBER
Department of Radiology Presbyterian-University Hospital DeSoto and O'Hara Streets Pittsburgh, Pennsylvania 15213 (DR. O N I K ) References 1. Smith DR: General Urology, East Norwalk, CT, Lange Medical, 1982, p 342. 2. Javadpour N: Recent Advances in Urologic Cancer, Baltimore, Williams and Wilkins, I982, pp 205-206. 3. Addonizio ]: Another look at eryoprostatectomy, Cryobiology 19:223 (1982). 4. Bonney WV¢, et ah Cryosurgery in prostate cancer: survival, Urology 19:37 (1982). 5. Onik G, et al: Ultrasonic characteristics of frozen liver, Cryobiology 21" 321 (1984). 6. Onik G, et ah Sonographic monitoring of hepatic cryosurgery in an experimental animal model, AJR 144:1043 0985). 7. Onik G, et ah Monitoring hepatic cryosurgery with sonography, AJtt 147:665 (1986). 8. Onik G, et al: Ultrasound eharaeteristies of frozen prostate, Radiology 168:629 (1988). 9. Jewett HJ: The present status of radical prostatectomy for Stage A and Stage B prostatic cancer, Urol Clin North Am 2:105 (1975).
10. Whitmore WF Jr, Hilaris B, and Grabstald H: Retropubic implantation of iodine-125 in the treatment of prostatic cancer, J Urol 108:918 0972). l l . Herr HW: Complication of pelvie lymphadeneetomy and retropubie prostatic 1-125 implantation, Urology 14:226 (1979). 12. Ando K: Cryoprostatectomy under control of ultrasonotomography, presented at 14th Congress of International Urologic Society, September, 1982. 13. Van J: Early prostate surgery may not be worth the risk, Chieago Tribune, Sept. I4, 1989, p 1.
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281
