A prospective randomized comparison of diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy

The aim of this study is to elucidate the diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy for prostate cancer. We prospectively randomized 200 consecutive men into two groups to undergo systematic prostate biopsy. Overall positivity for cancer was similar (47% by transperineal and 53% by transrectal; P=0.480). However, in case with 'gray zone' PSA (from 4.1 to 10.0 ng/ml), significantly more cores were positive when approach was transperineal, especially among transition zone cores. Therefore, urologist preferences are sufficient for choosing an approach, except for a possible small advantage of transperineal biopsy when PSA is in gray zone.     

Frameless image-guided stereotactic brain biopsy procedure: diagnostic yield, surgical morbidity, and comparison with the frame-based technique

OBJECT: The gold standard for stereotactic brain biopsy target localization has been frame-based stereotaxy. Recently, frameless stereotactic techniques have become increasingly utilized. Few authors have evaluated this procedure, analyzed preoperative predictors of diagnostic yield, or explored the differences in diagnostic yield and morbidity rate between the frameless and frame-based techniques. METHODS: A consecutive series of 110 frameless and 160 frame-based image-guided stereotactic biopsy procedures was reviewed. Associated variables for both techniques were reviewed and compared. All stereotactic biopsy procedures were included in a risk factor analysis of nondiagnostic biopsy sampling. Frameless stereotaxy led to a diagnostic yield of 89%, with a total permanent morbidity rate of 6% and a mortality rate of 1%. Larger lesions were fivefold more likely to yield diagnostic tissues. Deep-seated lesions were 2.7-fold less likely to yield diagnostic tissues compared with cortical lesions. Frameless compared with frame-based stereotactic biopsy procedures showed no significant differences in diagnostic yield or transient or permanent morbidity. For cortical lesions, more than one needle trajectory was required more frequently to obtain diagnostic tissues with frame-based as opposed to frameless stereotaxy, although this factor was not associated with morbidity. CONCLUSIONS: With regard to diagnostic yield and complication rate, the frameless stereotactic biopsy procedure was found to be comparable to or better than the frame-based method. Smaller and deep-seated lesions together were risk factors for a nondiagnostic tissue yield. Frameless stereotaxy may represent a more efficient means of obtaining biopsy specimens of cortical lesions but is otherwise similar to the frame-based technique.     

A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol

Study Type – Diagnostic (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? Several studies have shown that increasing the number of prostate biopsy cores will increase the detection rate of prostate cancer, but also risks overdiagnosing insignificant cancer, particularly in the elderly. Our study suggests that there is no significant advantage in using the Vienna nomogram to determine the number of prostate biopsies to be taken, compared to an eight‐core biopsy protocol.

OBJECTIVE

• ? To compare prostate cancer detection rates using the Vienna nomogram versus an 8‐core prostate biopsy protocol. To compare the complication rates of transrectal prostate biopsy in the two groups.

PATIENTS AND METHODS

• ? In a prospective randomized trial, men with a serum PSA ≥ 2.5 ng/ml were stratified according to serum PSA (I = PSA 2.5–10; II = PSA 10.1–30; III = PSA 30.1–50 ng/mL) and were then randomized to group A (number of cores determined according to the Vienna nomogram) or group B (8‐core prostate biopsy).
• ? Statistical analysis was performed using Student’s t‐test for parametric data, Mann‐Whitney test for nonparametric data and Fisher’s exact test for contingency tables. A two‐tailed p‐value <0.05 was accepted as statistically significant.

RESULTS

• ? In the period July 2006 to July 2009, 303 patients were randomized to group A (n = 152) or group B (n = 151). There were no significant differences in serum PSA, prostate volume, PSA density or post‐biopsy complications between the groups.
• ? The cancer detection rate was lower in group A than in group B for the whole study cohort (35.5% vs 38.4%), for those with PSA < 10 ng/ml (28.1% vs 33%) and for those with prostate volume >50 ml (22% vs 25.8%). These differences were not statistically significant (NSS).

CONCLUSION

• ? These findings suggest that there is no significant advantage in using the Vienna nomogram to determine the number of prostate biopsy cores to be taken, compared to an 8‐core biopsy protocol.

     

A prospective randomized clinical assessment of a new pigtail central venous catheter in comparison with standard alternatives

The Cook Pigtail central venous catheter (CVC) has been designed to diminish the risk of vascular perforation and consequent cardiac tamponade. With the participation of 12 consultant anaesthetists and 19 registrars, adults undergoing elective surgery were randomized to receive either a Pigtail (n = 101) or their consultant anaesthetists' "standard" CVC (n = 102). Median ease of insertion was rated 8 for Pigtail CVCs and 9 for standards (10 being best; P = 0.001). Arrhythmias occurred during 16 standard and 33 Pigtail central venous catheter insertions (P < 0.006). No significant difference was found in insertion time or radiographically assessed tip depth for standard and Pigtail central venous catheters. A perforated right atrium of uncertain cause occurred in a patient who received an Arrow triple-lumen central venous catheter. Participating consultant anaesthetists preferred their "standard" central venous catheter for routine use, but five indicated that they would select a Cook Pigtail where long-term use was planned because of in vitro evidence of its greater safety.     

Reassessing the diagnostic yield of saturation biopsy of the prostate

OBJECTIVE: Prostate biopsy remains the gold standard for detection of prostate cancer (PCa). This study was performed to determine whether saturation biopsy (>or= 24 cores) detects more prostate cancer than a standard 12-18 core office biopsy technique. METHODS: We conducted a nonrandomized cohort study of a consecutive series of prostate biopsies. The primary outcome assessed by both univariate and multivariate analysis was the detection of PCa, whereas the secondary outcomes of HGPIN (high-grade prostatic intraepithelial neoplasia) and ASAP (atypical small acinar proliferation) were also analyzed. RESULTS: From September 2005 to June 2006, a total of 469 patients undergoing prostate biopsy were included in this study. A standard office prostate biopsy was performed in 301 men, whereas 168 underwent a saturation biopsy. Age, body mass index (BMI), prostate volume, and family history of PCa were similar. However, patients in the saturation biopsy cohort were more likely to have had prior biopsies, higher prebiopsy PSA, longer PSA doubling times, and to carry more frequent diagnoses of HGPIN or ASAP (all p<0.05). After adjusting for covariates, saturation biopsy did not detect more abnormal pathology than standard office prostate biopsy, including PCa (OR, 1.2; p=0.339), HGPIN (OR, 1.4; p=0.368), or ASAP (OR, 2.2; p=0.201). CONCLUSIONS: Saturation biopsy does not appear to detect more abnormal prostate pathology than standard office biopsy of the prostate. This procedure may be associated with increased cost and patient morbidity.     

Pain and morbidity of transrectal ultrasound guided prostate biopsy: a prospective randomized trial of 6 versus 12 cores

PURPOSE: An increasing number of studies suggest that 6-sector transrectal ultrasound guided biopsy of the prostate provides insufficient material to detect all clinically important prostate cancers and more cores may improve detection rates. We performed a prospective, randomized study to determine the effect of increasing the number of cores from 6 to 12 on pain and other morbidity associated with the biopsy procedure. MATERIALS AND METHODS: A total of 160 men (44 black, 28%) with a mean age plus or minus standard deviation of 65+/-8 years who had serum prostate specific antigen between 2.5 and 20.0 ng./ml. and/or digital rectal examination findings suspicious for cancer were prospectively randomized to undergo 6 or 12-core biopsy. Patients completed a self-administered questionnaire addressing pain and other morbidity before, and immediately and 2 and 4 weeks after biopsy. RESULTS: There was no difference between groups in mean pain scale with time for abdominal and rectal pain. For probe insertion, needle insertion and overall pain there was a significant increase in pain recalled at 2 which persisted at 4 weeks compared to immediately after biopsy. However, there was no difference for these 3 post-biopsy pain measures between the 6 and 12-core groups. In the 12-core group there was a statistically significant increase in hematochezia and hematospermia (24% versus 10%, p = 0.04 and 89% versus 71%, p = 0.01, respectively) but no significant difference between groups reporting morbidity as a moderate or major problem. There was no significant change in International Prostate Symptom Score, fever or hospitalization in the 12-core group. CONCLUSIONS: The 12-core prostate biopsy procedure is generally well tolerated and can be safely performed with no significant difference in pain or morbidity compared to the 6-core procedure.     

Local anesthesia reduces pain associated with transrectal prostatic biopsy. A prospective randomized study

INTRODUCTION: To test the hypothesis that periprostatic block could completely relief prostatic biopsy-associated pain. MATERIALS AND METHODS: Patients scheduled for transrectal ultrasound guided prostate biopsy were randomized (1:1:1 ratio) to no analgesia (group A), endorectal enema of 1% lidocaine gel (group B) or transrectal periprostatic block (group C). All patients underwent 10 core TRUS-guided biopsy. After the procedure, a ten visual analogue pain score (VAS) from 0 = no discomfort to 10 = severe pain was administered to the biopsied patients and a global estimation of pain associated with the procedure was obtained. The study design included interim analysis of pain score after the first 60 patients were enrolled. Kruskal-Wallis test for unpaired data was used for statistical analysis. Data are presented as mean, median (range). RESULTS: Sixty patients were enrolled between May 2003 and December 2003 and all patients were evaluable. Mean and median age was 68.5 and 69 (range 53-82) years, respectively. Mean and median PSA was 86.8 and 9 ng/ml (range 0.58-4.111), respectively. No major side effects were observed. Patients in group A scored at VAS a median 4, mean 5.5 +/- 2.3 (range 3-10). Patients in group B scored a median 4, mean 5.5 +/- 2.7 (range 3-10) (p = 0.237). Patients receiving periprostatic injections of carbocaine (group C) scored a median 0, mean 0.5 +/- 0.8 (range 0-2). The level of pain reported by this group of patients was significantly different from those reported by patients who performed prostatic biopsy without anesthesia or with intrarectal anesthetic jelly (p = 0.00001). In the periprostatic block group 65% of patients referred no pain after the procedure (VAS = 0) while all patients in the other groups experience some degree of pain. CONCLUSION: The use of bilateral periprostatic block is a very effective and useful technique, well tolerated by the patient, which almost completely abolishes the pain and discomfort associated with the prostatic biopsy procedure.     

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.     

A prospective randomized study for comparing bipolar plasmakinetic resection of the prostate with standard TURP

OBJECTIVES: To compare clinical results of plasmakinetic (PK) resection vs. standard monopolar resection of the prostate, i.e. transurethral resection of the prostate (TURP). MATERIALS AND METHODS: 48 patients were included in this study between January 2003 and October 2003. They were randomized into two groups (TURP:PK) with a ratio of 1:1. PK resections (n = 24) were carried out by using PlasmaKinetic Tissue Management System (Gyrus Medical Ltd, Cardiff, UK) and PlasmaSect electrodes. TURPs (n = 24) were done by using a 26-Fr continuous-flow resectoscope and Karl Storz 27040 electrodes. Patients were assessed for safety and efficacy by measuring the IPSS and maximum flow rates at 1, 3, 6 and 12 months and residual urine measurement at 3, 6 and 12 months and transrectal ultrasonography at 6 months. RESULTS: The patients' ages ranged from 50 to 82 (mean 64 +/- 10) years. Groups were similar for operation time, bleeding score, resected tissue, catheterization time and irrigated volume. Mean serum Na levels at the end of the operation were 141.7 +/- 5.1 in the TURP group and 145.2 +/- 4.4 in the PK group (p = 0.013). The IPSS, QOL score and Q(max) had improved significantly in the postoperative period without any differences in either group. CONCLUSIONS: The main advantage of PK resection seems to be decreasing the risk of TUR syndrome, thus, larger prostates could be treated without a time limitation, theoretically. However, this technique brings no advantages in terms of intra- and postoperative bleeding, hospital stay, operation time and late complications.     

Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity

OBJECTIVE: To determine if a volume-adjusted increase in the number of biopsy cores could detect more prostate cancers than the standard sextant biopsy alone, without increasing morbidity, and to determine its applicability in Malaysian patients, as a standard sextant biopsy misses 20-25% of prostate malignancies. PATIENTS AND METHODS: In a prospective randomized study of patients undergoing transrectal ultrasonography (TRUS)-guided biopsy for a prostate-specific antigen (PSA) level of 4-20 ng/mL without abnormal digital rectal examination (DRE), the men were divided into five main groups (A-E) with prostate volumes of <20, 20-40, 40-60, 60-80 and >80 mL, respectively. Patients in groups B-E were randomized into sextant (B1 to E1) and increased biopsy-core subgroups, i.e. B2 (eight cores), C2 (10 cores), D2 (12 cores) and E2 (14 cores). The morbidity profile was also evaluated during and after TRUS biopsy, assessing a pain score, rectal bleeding, haematuria, haemospermia and development of fever. In all, 132 patients were recruited (mean age 67.8 years; mean PSA 9.41 ng/mL). RESULTS: The overall cancer detection rate was 24% (32 men). Taking more cores detected 65.5% of cancers, and the sextant biopsy 34.5% (P = 0.0025), but did not increase the overall morbidity. CONCLUSIONS: The volume-adjusted, increased-core regimen significantly increased the positive biopsy rate of TRUS-guided prostate biopsies with no added morbidity.     

Hemiresection of the prostate: short-term randomized comparison with standard transurethral resection

BACKGROUND AND PURPOSE: During transurethral resection of the prostate (TURP) for a very large and vascular gland in a medically compromised patient, there may arise the need for quick termination of the procedure because of medical problems that develop as a result of fluid absorption or bleeding if the surgery is prolonged. In such a situation, an alternative solution proposed by us is termination of the procedure after complete resection of one lateral lobe (and the median lobe, if present) of the prostate (hemiresection). PATIENTS AND METHODS: From January 1998 to December 2001, 161 consecutive symptomatic men with prostates >50 cc and an indication for prostatectomy were randomized to receive either a standard TURP (group 1; 80 patients) or prostatic hemiresection; i.e., complete resection of one lateral lobe and the median lobe, if present (group 2; 81 patients). The two groups were comparable in terms of age and prostate size. Preoperative and postoperative parameters were compared in the two groups using Student's t-test. RESULTS: Resected tissue weight was significantly greater in group 1, while the resection time and operative blood loss were significantly lower in group 2. The two groups had comparable improvement in symptom score and flow rate. CONCLUSIONS: Hemiresection of the prostate produces short-term functional results comparable to those of standard TURP in patients with prostates >50 cc, with shorter operative duration and significantly less bleeding. It is an acceptable surgical option in medically compromised patients with significant cardiac, pulmonary, or renal comorbidity.     

Lack of effect of intrarectal lidocaine for pain control during transrectal prostate biopsy: a randomized prospective study

INTRODUCTION AND OBJECTIVES: Transrectal ultrasound guided biopsy is an essential part in the diagnosis of prostate cancer. Although this procedure is well tolerated by most patients, sometimes it can result in some uneasiness. In this randomised double-blind placebo controlled study, we evaluated the effectiveness of intrarectal lidocaine during TRUS guided biopsy. MATERIALS AND METHODS: 100 consecutive eligible patients who had elevated total prostate specific antigen (tPSA) and/or abnormal digital rectal examination (DRE) were included into this study. Patients were randomised into two groups. Group I received 20 cc of 2% intrarectal lidocaine 20 minutes before transrectal ultrasound guided biopsy and Group II received same amount of serum physiologic. Pain was assessed using a 10 point modified visual analog scale. RESULTS: Mean patient age was 65.5+/-2.5 and 64.5+/-11.5 years, mean tPSA was 12.3+/-3.6 and 11.3+/-1.7 ng/ml, mean biopsy duration was 6.8+/-2.5 and 6.6+/-2.2 minutes, mean pain score during transrectal ultrasound guided biopsy was 4.8+/-2.2 and 4.4+/-2.1 in Groups I and II, respectively. No statistically significant difference was observed with respect to age, tPSA, mean biopsy duration and pain score between these groups. There was only one patient who could not tolerate the procedure at all, and he was paradoxically in the lidocaine group. CONCLUSION: The use of intrarectal lidocaine is not superior to placebo during transrectal prostate biopsy for pain control.     

Does periprostatic block reduce pain during transrectal prostate biopsy? A randomized,placebo-controlled,double-blinded study

Introduction  

Currently, the use of local anesthetic at the time of transrectal ultrasound-guided biopsy of the prostate is not universally accepted, as the needle injection itself causes pain. In prior studies, lidocaine was compared to placebo in separate patient groups. We present the first study to evaluate both lidocaine and placebo injected in each patient.     

Antibiotic prophylaxis for transrectal prostate biopsy: A prospective randomized study of tosufloxacin versus levofloxacin

Objectives:   To assess the efficacy of tosufloxacin as a prophylactic agent for transrectal biopsy of the prostate (TBP), we conducted a randomized prospective study comparing tosufloxacin versus levofloxacin.
Methods:   A randomized prospective study comparing tosufloxacin versus levofloxacin was performed. In group A, 124 patients received 300 mg tosufloxacin tosilate (including 204 mg tosufloxacin) twice daily for 2 days, with the initial dose being 2 h prior to biopsy. In group B, 119 patients received 200 mg levofloxacin in the same manner.
Results:   Infectious complications were reported equally in six cases in each group (4.8% in group A and 5.0% in group B). Each group included five cases of acute prostatitis and one of cystitis. Six patients suffering from prostatitis required hospitalization, while those with symptomatic urinary tract infection were treated as outpatients.
Conclusions:   Tosufloxacin was as effective as levofloxacin when administered twice daily for 2 days as prophylaxis for TBP, which suggests that this regimen is useful for reducing the clinical and febrile infection rate following TBP.