A Multicentre Clinical Trial Evaluating a Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer.

BACKGROUND: This study evaluated the safety and performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node biopsy (SeLNB) in a prospective, open-label, multicentre, single-arm clinical trial. OBJECTIVE: The main objective was to determine the sentinel lymph node (SeLN) detection rate with the drop-in gamma probe system. The secondary objectives were overall performance and safety. DESIGN, SETTING, AND PARTICIPANTS: At three European centres, patients received an ultrasound-guided systemic and tumour-targeted injection of [99mTc]Tc-nanocolloid followed by planar lymphoscintigraphy and/or single-photon emission computerised tomography. The next day, manual laparoscopic or robot-assisted radical prostatectomy was performed, including SeLN dissection (SeLND) and extended pelvic lymph node dissection (ePLND). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: SeLNs were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). The primary endpoint of the study was the SeLND rate defined as the percentage of patients with at least one SeLN detected in vivo by the drop-in probe. The secondary endpoints included diagnostic performance, ease of SeLN detection, number of SeLNs detected, and safety. The first two patients at each site (six in total) were used for familiarisation. RESULTS AND LIMITATIONS: A total of 27 patients were included in the main analysis. SENSEI successfully detected at least one SeLN in all 27 patients, resulting in a detection rate of 100% (95% confidence interval 87.2-100%). The total number of SeLNs identified with SENSEI was 85 (median three SeLNs per patient, range 1-6); of these 85 SeLNs, 12 were located outside of the ePLND template. In the nine patients in whom the RLGP was used, SENSEI detected two SeLNs that could not be detected with the RLGP due to manoeuvrability restrictions. Ten of the 27 patients were pN1; four patients had a false-negative SeLNB. No adverse events or complications were related to the use of the drop-in probe. CONCLUSIONS: The study demonstrated that the drop-in gamma probe meets the performance and safety requirements for SeLNB in PCa. The device provided improved manoeuvrability and SeLN detection compared with the conventional RLGP. PATIENT SUMMARY: A novel device was tested for detecting sentinel lymph nodes during minimally invasive surgery for prostate cancer. In this first evaluation, the performance and safety of the device were evaluated positively.

A Drop-in Gamma Probe for Minimally Invasive Sentinel Lymph Node Dissection in Prostate Cancer: Preclinical Evaluation and Interim Results From a Multicenter Clinical Trial.

PURPOSE: This study evaluated the performance of a drop-in gamma probe for prostate cancer (PCa) sentinel lymph node dissection (SLND) in a pelvic phantom, porcine model, and in PCa patients as part of an ongoing prospective multicenter clinical trial. METHODS: Two design variants of the drop-in gamma probe (SENSEI; Lightpoint Medical Ltd) were assessed in the pelvic phantom, and the preferred design was evaluated in a porcine model with clinically representative volumes and 99mTc activities. In the clinical trial, radical prostatectomy, SLND, and extended pelvic lymph node dissection were performed the day after 99mTc-nanocolloid injection and imaging. Sentinel lymph nodes (SLNs) were detected with the drop-in probe and a rigid laparoscopic gamma probe (RLGP). An interim analysis was performed after 10 patients were recruited. RESULTS: The narrow field of view probe design outperformed the wide field of view design in the pelvic phantom (detection rate, 100% vs 50%). In the porcine model, all activity concentrations could be successfully detected. The drop-in gamma probe successfully detected SLNs in all 10 patients (detection rate, 100%). Two of the SLNs identified by the drop-in gamma probe could not be found with the RLGP. No false-negative cases and no adverse events related to the SLND procedure or the drop-in gamma probe occurred. CONCLUSION: The drop-in gamma probe meets the usability and performance requirements for SLND in PCa and provides performance advantages over the RLGP. The final clinical study results will confirm the performance of the technique across multiple sites.

[Transperitoneal laparoscopic adrenalectomy: results after 70 procedures]. / Adrenalectomía laparoscópica transperitoneal: resultados tras 70 procedimientos.

OBJECTIVES: To present our surgical experience in laparoscopic adrenalectomy after 70 procedures, comparing our results with the published series and analyzing the learning curve. METHODS: Between June 1997 and December 2007 we performed 87 adrenalectomies (70 transperitoneal laparoscopy, 1 retroperitoneoscopy and 16 open surgery); 60% were female. Mean age was 54 years 15-80); 35 were left adrenalectomies, 33 right and one bilateral. Mean mass size was 3,7 cm (1-10). All patients were assessed regarding the following variables: preoperative diagnosis, histopathology, operative time, blood loss, complications, conversion to open surgery and hospital stay. We compared the results of the first 40 surgical procedures (Group 1) and the last 30 (Group 2). We also compared our re-sults with published series. Mean time follow-up was 12 months (2-60). RESULTS: The most frequent preoperative diagnoses were: active suprarenal mass (50%), incidentaloma (20%), pheochromocytoma (20%). Histopathology confirmed 60% adenomas, 14% pheochromocytomas and 11% cortical nodular hyperplasia. Mean operative time was 161 minutes (60-300). Average blood loss (hematocrit) was 5.2 (1-10). Conversion and complication rate were 8.5 and 7%, respectively. Mean hospital stay was 4 days (2-30). In group 2, only reduction on mean operative time (120 min) and hospital stay (3 days) was statistically significant. CONCLUSIONS: Transperitoneal laparoscopic adrenalectomy is a feasible and safe procedure in urological groups with previous laparoscopic experience. Our results are similar to the published series and confirm the efficacy, safety and reproducibility of this technique.

[Initial experience in the diagnosis and treatment of superficial bladder tumors with Hexvix]. / Experiencia inicial en el diagnóstico y tratamiento del tumor vesical superficial con Hexvix.

OBJECTIVES: White light cystoscopy is the current standard for the diagnosis of bladder cancer and monitorization for recurrence. Recent studies suggest that porphyrin based fluorescence cystoscopy may improve endoscopic detection of bladder tumors. We aimed to evaluate the improvement that hexaminolevulinate fluorescence cystoscopy could lead in bladder cancer detection and treatment at one single centre. METHODS: Between September 2006 and September 2007 a total of 39 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM hexaminolevulinate (HAL) for 1 hour. The bladder was inspected using white light cystoscopy (WLC), followed by blue light (fluorescence) cystoscopy (BLC). Papillary and suspicious lesions were resected for histological examination. Mean age was 70.1 years (50-86). Thirty patients were male (76.9%) and 9 female (23.1%). The tumor characteristics were: 18% primary tumors, 51% recurrences and 30% control cystoscopies. 24 patients had previously received some treatment (9 MMC and 15 BCG). Only 7 patients had previous positive urine cytology. RESULTS: All papillary lesions visualized with WLC were confirmed by BLC (18 patients). From these, 17 have positive biopsies (6 pTaG1, 9 pT1G1-3, 1 pT2, 1 CIS). In 15 patients (38.4%) we found at least 1 lesion more with BLC. In this group 8 cases (20.5%) had positive histological diagnosis (3 pTaG1, 2 pT1G3, 3 CIS). In five patients (13%) post-TUR therapeutic management has changed by using BLC (BCG vs MMC). All four patients with CIS were diagnosed by BLC. There was no evidence of local or systemic side effects due to HAL in the postoperative time. CONCLUSIONS: Our results suggest there is an improvement in the diagnosis of papillary and flat lesions in bladder cancer by using HAL fluorescence cystoscopy. This has changed the management in the postoperative period (MMC vs BCG) in 13% of the patients. Obviously, we need more patients to assess our data and long-term follow-up to analyze the impact in terms of tumor recurrence and progression.