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Biomedical subjects

F F Marshall

Publications and source records attributed to F F Marshall.

At least 19 recordsLinked to original sources
PubMed2001

Expression profiling of renal epithelial neoplasms: a method for tumor classification and discovery of diagnostic molecular markers.

The expression patterns of 7075 genes were analyzed in four conventional (clear cell) renal cell carcinomas (RCC), one chromophobe RCC, and two oncocytomas using cDNA microarrays. Expression profiles were compared among tumors using various clustering algorithms, thereby separating the tumors into two categories consistent with corresponding histopathological diagnoses. Specifically, conventional RCCs were distinguished from chromophobe RCC/oncocytomas based on large-scale gene expression patterns. Chromophobe RCC/oncocytomas displayed similar expression profiles, including genes involved with oxidative phosphorylation and genes expressed normally by distal nephron, consistent with the mitochondrion-rich morphology of these tumors and the theory that both lesions are related histogenetically to distal nephron epithelium. Conventional RCCs underexpressed mitochondrial and distal nephron genes, and were further distinguished from chromophobe RCC/oncocytomas by overexpression of vimentin and class II major histocompatibility complex-related molecules. Novel, tumor-specific expression of four genes-vimentin, class II major histocompatibility complex-associated invariant chain (CD74), parvalbumin, and galectin-3-was confirmed in an independent tumor series by immunohistochemistry. Vimentin was a sensitive, specific marker for conventional RCCs, and parvalbumin was detected primarily in chromophobe RCC/oncocytomas. In conclusion, histopathological subtypes of renal epithelial neoplasia were characterized by distinct patterns of gene expression. Expression patterns were useful for identifying novel molecular markers with potential diagnostic utility.

Adult↗
PubMed2001

Laparoscopic radical nephrectomy: cancer control for renal cell carcinoma.

PURPOSE: We evaluated the clinical efficacy of laparoscopic versus open radical nephrectomy in patients with clinically localized renal cell carcinoma. MATERIALS AND METHODS: Between 1991 and 1999, 67 laparoscopic radical nephrectomies were performed for clinically localized, stages cT1/2 NXMX, pathologically confirmed renal cell carcinoma. During this period 54 patients who underwent open radical nephrectomy with pathologically confirmed stages pT1/2 NXMX disease were also identified. Medical and operative records were retrospectively reviewed and telephone followup was done to assess patient status. RESULTS: In the laparoscopic and open groups average tumor size was 5.1 (range 1 to 13) and 5.4 cm. (range 0.2 to 18), respectively, which was not statistically significant. No patient had laparoscopic port site, wound or renal fossa tumor recurrence in either group. All patients were followed at least 12 months. In the laparoscopic group 2 cancer specific deaths occurred at a mean followup of 35.6 months. In the open group there were 2 cancer specific deaths and 3 cases of disease progression at a mean followup of 44 months. Kaplan-Meier disease-free survival and actuarial survival analysis revealed no significant differences in the laparoscopic and open radical nephrectomy groups. Also, no differences were noted in the complication rate. CONCLUSIONS: Laparoscopic radical nephrectomy is an effective alternative for localized renal cell carcinoma when the principles of surgical oncology are maintained. Initial data show shorter patient hospitalization and effective cancer control with no significant difference in survival compared with open radical nephrectomy.

Adult↗
PubMed2001

Prognostic assessment of nonmetastatic renal cell carcinoma: a clinically based model.

OBJECTIVES: Determining the recurrence risk in patients treated for renal cell carcinoma (RCC) is important for providing prognostic information and planning potential surveillance strategies. The pathologic stage has been the most widely used single prognostic variable. However, with minimally invasive treatment modalities, the pathologic stage may not be readily available. We developed a biostatistical prognostic model for postoperative RCC that is independent of the pathologic stage. METHODS: The records of 296 patients who underwent open nephrectomy for RCC at Johns Hopkins Hospital between 1990 and 1999 were reviewed. Cox proportional hazards regression analysis was used to generate a prognostic model. RESULTS: The recurrence risk (R(rec)) was determined from this model: R(rec)=1.55 x presentation (0-1)+0.19 x clinical size (in centimeters). Using this equation, 79% of patients were identified as low risk compared with 45% of patients considered low risk by pathologic stage (pT1). Moreover, the separation between the high and low-risk survival curves increased. CONCLUSIONS: This model is the first to our knowledge that uses purely clinical variables to assess the postoperative prognosis in patients with RCC. These results, although not validated, provide substantial evidence that preoperative clinical variables may be used instead of the pathologic stage to determine the risk of recurrence. Uncoupling the reliance on pathologic stage for prognostic information removes a potential barrier to novel minimally invasive treatments for renal malignancy and provides a standard to which observation protocols can be compared. In the future, this model may facilitate selection of appropriate patients for less toxic adjuvant or neoadjuvant therapies.

Aged↗
PubMed2001

Accumulation of mitochondrial DNA deletions in the malignant prostate of patients of different ages.

It has been shown that mitochondrial DNA (mtDNA) deletion mutations accumulate with age in many tissues of the body. However, to date no one has shown that these deletions occur in the malignant prostate. Therefore, we hypothesize that such deletions do occur in the prostate and increasingly so with advanced age. To test this hypothesis, DNA was isolated from 34 radical prostatectomy specimens, and the entire mitochondrial genome (16.5kb) was amplified using long range PCR (LXPCR). The LXPCR products were visualized by gel electrophoresis, and the presence of low molecular weight (<16kb) bands was considered evidence of large mtDNA deletions. In order to show that these lower molecular weight LXPCR bands were not simply PCR artifact, we also digested mtDNA from a subset of the same patients and did Southern analysis with a mtDNA probe. Southern blots confirmed the existence of large deletions in every sample tested. Furthermore, several of the specific deletions identified by LXPCR were also seen in the Southern blots. From the LXPCR data, we found that as the age of the specimen increased, so did the average number of low molecular weight bands (i.e. deletions). In particular, one prominent band was seen at 1.2kb and became more consistent with advanced age.

Adult↗
PubMed2000

Cancer cells engineered to secrete granulocyte-macrophage colony-stimulating factor using ex vivo gene transfer as vaccines for the treatment of genitourinary malignancies.

When irradiated and administered intradermally as vaccines, cancer cells engineered to secrete high levels of granulocyte-macrophage colony-stimulating factor (GM-CSF) by gene transfer elicit potent anticancer immune responses in a variety of animal tumor models. Upon vaccination, antigens present in the cancer cells are phagocytosed and processed by skin dendritic cells. These dendritic cells then prime anticancer immune responses by presenting antigenic peptides to T cells. The immune responses generated are capable of eradicating small but lethal cancer cell inocula with minimal toxicity in preclinical animal tumor studies. To develop this vaccination strategy for the treatment of human genitourinary cancers, we have conducted phase I clinical trials using human genitourinary cancer cells as sources of cancer cell antigens. In the first human clinical trial of genetically engineered cancer cell vaccines, a phase I clinical trial of kidney cancer cell vaccines (n = 18), kidney cancer cells were removed at surgery, propagated briefly in vitro, and then genetically modified to secrete high levels of GM-CSF via ex vivo transduction with the retrovirus MFG-GM-CSF. After irradiation, the kidney cancer cells were administered as vaccines to 18 patients with advanced kidney cancers. Vaccine treatment, which caused few side effects, nonetheless appeared to trigger anticancer immune responses manifest as conversion of delayed-type hypersensitivity (DTH) skin responses against irradiated autologous cancer cells after vaccination. Biopsies of vaccine sites yielded findings reminiscent of biopsies from preclinical animal model studies, with evidence of vaccine cell recruitment of dendritic cells, T cells, and eosinophils. One patient with measurable kidney cancer metastases treated at the highest vaccine dose level experienced a partial treatment response. The bioactivity of GM-CSF-secreting autologous cancer cell vaccines was confirmed in a phase I clinical trial for prostate cancer (n = 8). Vaccine cells were prepared from surgically harvested prostate tumors by ex vivo transduction with MFG-GM-CSF in a manner similar to that used for the kidney cancer trial. Vaccine treatment was well tolerated and associated with induction of anticancer immunity as assessed using DTH skin testing. In addition, new antiprostate cancer cell antibodies were detected in serum samples from treated men as a consequence of vaccination. These first clinical trials of GM-CSF-secreting cancer cell vaccines for the treatment of genitourinary cancers have demonstrated both safety and bioactivity, in that very few side effects have been seen and anticancer immune responses have been detected. Future clinical studies will be required to assess vaccine treatment efficacy, refine vaccination dose and schedule, define the appropriate clinical context for the use of such vaccines, and ascertain optimal combinations involving vaccines and other local or systemic anticancer treatments.

Adult↗
PubMed2000

Renal ablative cryosurgery in selected patients with peripheral renal masses.

OBJECTIVES: To present the preliminary results of renal ablative cryosurgery in selected patients. METHODS: Seven patients were treated, all of whom had small peripheral tumors and chose not to undergo partial or radical nephrectomy. Four patients underwent a rib-sparing flank incision; the remaining three underwent laparoscopy. All tumors were biopsied before cryoablation. Intraoperative ultrasound was used to monitor the cryolesion. RESULTS: There were no intraoperative complications. The estimated blood loss averaged 111 mL. To date, 6 of the 7 patients have undergone at least one follow-up computed tomography scan (14.2 months average follow-up); all these scans demonstrated partial resolution of the lesion. Clinically, the patients tolerated the procedure without any renal complications or significant changes in creatinine. CONCLUSIONS: This limited clinical trial has demonstrated the feasibility of treating small peripherally located renal tumors with cryosurgery with minimal morbidity and a favorable outcome. Further studies are necessary to determine the long-term efficacy of this treatment modality.

Aged↗
PubMed2000

Minilaparotomy radical retropubic prostatectomy: updated technique and results.

The purpose of this article is to reduce the incisional morbidity associated with standard radical retropubic prostatectomy using the minilaparotomy incision developed for pelvic lymph-node dissection, which was applied to radical retropubic prostatectomy. More than 522 patients underwent minilaparotomy radical retropubic prostatectomy from 1991 to 1997. Preoperative evaluation included history, physical examination, prostate-specific antigen (PSA), and Gleason's grade. Postoperative follow-up included serial PSA measurements and a determination of continence. The surgical technique is described in detail. Two hundred sixty-five patients responded to the mailed questionnaire out of a total 522 patients. Satisfactory continence, defined as 0 to 1 pad per day, was achieved in 85% of patients, and 83% of patients had a PSA < 0.2 at an average follow-up of 2.6 years. There was no operative mortality, and overall complication rate was similar to other surgeons. The typical patient was discharged home 3 days postoperatively. Minilaparotomy radical retropubic prostatectomy compares favorably with standard radical retropubic prostatectomy.

Humans↗
PubMed2000

A randomized prospective trial of intrarectal lidocaine for pain control during transrectal prostate biopsy: the Emory University experience.

PURPOSE: We prospectively evaluated the safety and efficacy of intrarectal lidocaine gel as anesthesia during transrectal prostate biopsy. MATERIALS AND METHODS: Of 63 consecutive men undergoing transrectal prostate biopsy 50 who qualified were enrolled in this study. Indications for the procedure were an abnormal prostate on digital rectal examination and/or elevated serum prostate specific antigen. Patients were randomized into group 1-25 who received 10 cc of 2% intrarectal lidocaine 10 minutes before the procedure and group 2-25 controls. No narcotics, sedation or analgesia was given. Pain during biopsy was assessed using a 10-point linear visual analog pain scale. RESULTS: In groups 1 and 2 median patient age was 63 and 66 years (p = 0.139), and median prostate specific antigen was 6.04 (range 1.07 to 263) and 7.24 (range 1.34 to 51.82) ng./ml. (p = 0.337). Digital rectal examination was normal and abnormal in 17 and 15 group 1, and in 8 and 10 group 2 patients, respectively. Ultrasound showed a median prostate volume of 43.6 cc (range 15.3 to 124) in group 1 and 40.3 (range 19.8 to 132) in group 2 (p = 0.710). Final histological results revealed prostate cancer in 7 men (28%) in each group. The median pain score during transrectal prostate biopsy was 2 (range 1 to 5) and 5 (range 1 to 7) in groups 1 and 2, respectively (p = 0.00001). No adverse events were noted. CONCLUSIONS: Intrarectal lidocaine gel is a simple, safe and efficacious method of providing satisfactory anesthesia in men undergoing transrectal prostate biopsy. We recommend its routine administration in all patients during this procedure.

Administration, Rectal↗
PubMed1999

Diagnosis of renal cancer by molecular urinalysis.

BACKGROUND: Organ-confined renal malignancies can be cured in the majority of patients, whereas more extensive lesions have a poor prognosis. We sought to develop a noninvasive test for renal cancer detection based on a novel molecular approach. METHODS: Matched urine and serum DNA samples were obtained before surgery from 30 patients with clinically organ-confined solid renal masses (25 with malignant tumors and five with tumors of low malignant potential) and were subjected to microsatellite analysis. Serum samples and urine samples obtained from 16 individuals without clinical evidence of genitourinary malignancy served as controls. RESULTS: Nineteen (76%) of the 25 patients with malignant tumors were found to have one or more microsatellite DNA alterations in their urine specimen, and 15 (60%) were found to have alterations in their serum DNA by microsatellite analysis. In every case, the microsatellite changes in urine or serum were identical to those found in the primary tumor. Three of five patients with tumors of low malignant potential were found to have DNA alterations in their urine, but none displayed alterations in their serum. Moreover, microsatellite alterations were not identified in either the urine or the serum samples from normal control subjects and patients with hematuria due to nephrolithiasis (renal stones). CONCLUSION: These data suggest that microsatellite DNA analysis of urine specimens provides a potentially valuable tool for the early detection of resectable kidney cancer. Furthermore, microsatellite analysis of serum samples reveals evidence of circulating tumor-specific DNA in approximately half of these patients and may reflect the propensity of these tumors to spread to distant sites at an early stage.

Aged↗
PubMed1999

Induction of immunity to prostate cancer antigens: results of a clinical trial of vaccination with irradiated autologous prostate tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor using ex vivo gene transfer.

Vaccination with irradiated granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting gene-transduced cancer vaccines induces tumoricidal immune responses. In a Phase I human gene therapy trial, eight immunocompetent prostate cancer (PCA) patients were treated with autologous, GM-CSF-secreting, irradiated tumor vaccines prepared from ex vivo retroviral transduction of surgically harvested cells. Expansion of primary cultures of autologous vaccine cells was successful to meet trial specifications in 8 of 11 cases (73%); the yields of the primary culture cell limited the number of courses of vaccination. Side effects were pruritus, erythema, and swelling at vaccination sites. Vaccine site biopsies manifested infiltrates of dendritic cells and macrophages among prostate tumor vaccine cells. Vaccination activated new T-cell and B-cell immune responses against PCA antigens. T-cell responses, evaluated by assessing delayed-type hypersensitivity (DTH) reactions against untransduced autologous tumor cells, were evident in two of eight patients before vaccination and in seven of eight patients after treatment. Reactive DTH site biopsies manifested infiltrates of effector cells consisting of CD45RO+ T-cells, and degranulating eosinophils consistent with activation of both Th1 and Th2 T-cell responses. A distinctive eosinophilic vasculitis was evident near autologous tumor cells at vaccine sites, and at DTH sites. B-cell responses were also induced. Sera from three of eight vaccinated men contained new antibodies recognizing polypeptides of 26, 31, and 150 kDa in protein extracts from prostate cells. The 150-kDa polypeptide was expressed by LNCaP and PC-3 PCA cells, as well as by normal prostate epithelial cells, but not by prostate stromal cells. No antibodies against prostate-specific antigen were detected. These data suggest that both T-cell and B-cell immune responses to human PCA can be generated by treatment with irradiated, GM-CSF gene-transduced PCA vaccines.

Antigens, Neoplasm↗
PubMed1999

Incidental non-Hodgkin's lymphoma in patients with localized prostate cancer.

OBJECTIVES: To determine the outcome of patients with clinically organ-confined prostate cancer undergoing radical retropubic prostatectomy for cure and incidentally discovered concurrent low-grade non-Hodgkin's lymphoma at time of surgery. METHODS: From September 1986 to September 1997, 4319 patients underwent radical retropubic prostatectomy at our institution. The records of 10 patients incidentally diagnosed to have low-grade non-Hodgkin's lymphoma at the time of radical prostatectomy were retrospectively reviewed. RESULTS: Of 4319 patients requiring radical prostatectomy, 10 (0.2%) were found to have low-grade non-Hodgkin's lymphoma. All 10 men had an uneventful postoperative course. Two patients subsequently developed progression of lymphoma, one of whom required treatment. One patient died of sepsis associated with his lymphoma and 1 patient died of an unrelated malignancy (lung cancer), both 7 years following surgery. Two patients developed biochemical prostate-specific antigen recurrence. The remainder of men were free of prostate cancer recurrence and experienced no progression of lymphoma at an average of 45 months (range 12 to 142). CONCLUSIONS: Patients with organ-confined prostate cancer, who are candidates for radical prostatectomy, experience long-term prostate cancer-free survival in the face of incidentally diagnosed low-grade lymphoma. Because the management of most incidentally discovered low-grade lymphomas is expectant, patients discovered at surgery to have this clinical entity should not be denied radical prostatectomy.

Aged↗
PubMed1999

Nuclear morphometry adds significant prognostic information to stage and grade for renal cell carcinoma.

OBJECTIVES: Identification of patients with a high probability of recurrence after nephrectomy for renal cell carcinoma (RCC) is required for adjuvant studies of new therapies. Nuclear morphometry predicts prognosis for prostate, bladder, and Wilms' tumors and in RCC according to previous small pilot studies. METHODS: To validate this finding, we studied an additional 101 patients who underwent nephrectomy for Stage pT1 to pT3 RCC at our institution from 1977 to 1993 for whom data regarding recurrence or disease-free survival of greater than 60 months were available. Patient records and pathology specimens were reviewed. Of the 101 patients, 66 (65%) did not experience recurrence with greater than 60 months of follow-up, and 35 (35%) had RCC recurrence with a median time to recurrence of 17 months. Nuclear shape descriptors were tested as predictors of disease recurrence after accounting for stage and grade in proportional hazards regression models. RESULTS: Range of ellipticity (hazards ratio 3.39, P = 0.014) was confirmed to be a significant predictor of recurrence. A prognostic model using stage, grade, and range of ellipticity identified three distinct groups: low, moderate, and high recurrence risk groups, with recurrence rates of 4%, 37%, and 63%, respectively, at 5 years of follow-up. Morphometry significantly (P = 0.018) improved prognostication on the basis of stage and grade alone in this multivariate model. CONCLUSIONS: Nuclear morphometry is valid and accurate in predicting relapse in early-stage RCC. The model can select patients with RCC for adjuvant therapies.

Carcinoma, Renal Cell↗
PubMed1999

Anomalies of the inferior vena cava and renal veins: embryologic and surgical considerations.

Anomalies of the inferior vena cava and renal veins occur infrequently but if unidentified can lead to significant morbidity during surgical exploration. An understanding of the embryologic development of the vena cava and its tributaries is necessary to understand the genesis of these sometimes complex anomalies and their accompanying anatomic variants. Newer radiologic modalities in the form of spiral computed tomography (CT) and three-dimensional reconstruction of spiral CT allow clear definition of the anatomy of these anomalies. Variations in the embryologic evolution of the vena cava dictate the different venous anomalies that may be encountered in the retroperitoneum. Additionally, the utility of newer radiologic modalities in the identification of these anomalies is discussed.

Humans↗
PubMed1999

Endoscopic reconstruction of vesicourethral obliteration after retropubic prostatectomy.

Complete vesicourethral obliteration after retropubic prostatectomy presents a challenging reconstructive problem. We report on 4 men with complete vesicourethral obliteration after radical (n = 3) or simple (n = 1) retropubic prostatectomy in which an antegrade-retrograde endoscopic approach was used to obtain durable urethral patency, with preservation of urinary continence and potency.

Aged↗
PubMed1999

Partial nephrectomy for centrally located tumors.

INTRODUCTION: Interest in nephron-sparing surgery has been spurred by the good long-term results of patients treated with partial nephrectomy. Partial nephrectomy entails the complete resection of renal tumor while leaving behind clear surgical margins and maximum functional renal parenchyma. TECHNICAL CONSIDERATIONS: We prefer to access the renal tumor by a flank incision. Intraoperative sonography is used to define the operative lesion and to search for multicentric tumors. A vascular clamp is placed on the renal hilum for vascular control. Regional hypothermia protects the kidney during renal ischemia. The perinephric fat is excised in situ with the renal tumor. Tumor base biopsies ensure negative margins. Meticulous dissection and tying of vessels improves hemostasis. Diluted methylene blue is directly injected into the renal pelvis to inspect for any intrarenal leakage. The argon beam coagulator is used routinely, and collagen (Avitene) is placed into the renal defect for hemostasis. The renal parenchyma and Gerota's fascia are reapproximated anatomically. A small drain is left in place, and the wound is closed in the usual manner. CONCLUSIONS: Recent studies continue to report that conservative surgery is as effective as radical nephrectomy for renal cell carcinoma, but the judgments in patient selection and operative management are paramount in determining its success.

Humans↗
PubMed1999

Orthotopic ileocolic neobladder reconstruction following radical cystectomy: history, technique and results of the Johns Hopkins experience, 1986-1998.

Reconstruction of the lower urinary tract using intestinal segments has become a standard component of the treatment of patients with bladder cancer. A variety of intestinal segments can be successfully used for this purpose. Between 1986 and 1998, the authors have used a composite ileocolic segment for neobladder reconstruction in patients desiring orthotopic reconstruction of the lower urinary tract. The early and late complication rates are 11% and 30%, respectively. Forty-five percent of men are potent postoperatively. Seventy-six percent of patients are continent both day and night. Three percent of our patients experience nocturnal enuresis, and 15% perform clean intermittent catheterization. Bothersome daytime stress urinary incontinence occurs in 3% of patients evaluated for this report. Although no contemporary studies demonstrate the superiority of a particular bowel segment for lower urinary tract reconstruction, the authors' long-term experience with the ileocolic neobladder suggests that this composite segment provides excellent results for lower urinary tract reconstruction after radical cystectomy.

Baltimore↗
PubMed1999

Laparoscopic renal cryoablation: acute and long-term clinical, radiographic, and pathologic effects in an animal model and application in a clinical trial.

OBJECTIVES: To evaluate renal cryosurgery by studying the feasibility of laparoscopic delivery and the radiographic characteristics and histopathologic effects in a porcine model using different freeze cycles. On the basis of the results, a clinical trial of laparoscopic cryosurgical ablation in select patients with clinical stage T1 renal tumors was started. MATERIALS AND METHODS: Twelve kidneys from six farm pigs underwent cryosurgery. Each kidney was treated with two freeze cycles to -180 degrees C. Six kidneys were retroperitonealized, and six were not. An abdominal CT scan was performed at various times to evaluate for the presence of urinoma or hematoma and to monitor lesion changes. Organs were harvested at times ranging from 24 hours to 13 weeks. Radiographic and histopathologic changes were recorded for each time period. Eight patients with small (average 2-cm) exophytic renal masses underwent laparoscopic biopsy and cryosurgical ablation using a 3- or 4.8-mm probe (Cryomedical Sciences Inc., Rockville, MD) for one 15-minute or two 5-minute freeze cycles to a temperature of -180 degrees C to extend the ice ball at least 7 mm beyond the tumor margin. RESULTS: Dense adhesions between the bowel and cryoablated renal tissue were encountered in all non-retroperitonealized kidneys, but no fistula formation was present. The retroperitonealized kidneys had minimal adhesion formation. None of the animals developed a urinary fistula. At 24 hours and 1 week, CT scanning demonstrated an enhancement defect corresponding to the region of the ice ball with no urinoma or hematoma. At 13 weeks, only a nonenhancing cortical defect was seen. At immediate harvest, hemorrhage was noted in the area of the ice ball with a sharp demarcation at the edge of the freeze zone. At 1 week, four distinct zones were seen: central necrosis, inflammatory infiltrate, hemorrhage, and fibrosis with regeneration. At 13 weeks, the necrotic tissue had been replaced with a circumscribed area of fibrosis. There were no intraoperative or postoperative complications in the eight patients. The estimated blood loss was 140 mL, and the mean hospital stay was 3.5 days. At a mean clinical follow-up of 7.7 (range 1-18) months and radiographic follow-up of 5 months; there have been no tumor recurrences or significant changes in the serum creatinine concentration. At 24 hours, there was an enhancement defect in the area of the ice ball. The CT images at 13 weeks showed a nonenhancing cortical defect in the area of the ice ball. CONCLUSIONS: Cryosurgery can be readily delivered laparoscopically, creating a discrete lesion at the time of treatment that appears to be consistent over time. In the animal studies, complete tissue necrosis developed in the freeze zone, followed by reabsorption, and by 13 weeks, fibrous tissue had replaced the defect. In the animal and human trials, there were no operative complications, urinomas, hematomas, or bowel or urinary fistulas. Follow-up imaging in human trials revealed a persistent nonenhancing defect in the area of the freeze zone. Long-term clinical follow-up will be necessary to determine the cancer-free survival rate.

Aged↗