Video-Assisted informed consent in endoscopic urology: a randomized trial on ureterorenoscopy.

PURPOSE: The aim of this study is to evaluate the possible beneficial effect of using the video - consent in the preoperative URS consent giving process. MATERIAL AND METHODS: Prospective randomized trial took place at two Italian tertiary-care centers from March 2022 to September 2022. Patients were randomly assigned to two groups: Group A (standard verbal/written informed consent) and Group B (informed consent supported by video). We investigated the impact of both types of the informed consent on the level of patients' anxiety assessed with the STAI questionnaire pre- and postoperatively. Additionally, we evaluated the effect of informed consents on the postoperative pain, measured with the VAS scale, and the number of assistances calls during hospitalization as secondary outcomes. To assess the satisfaction level related to the whole process, we asked patients to rate their experience on a scale of 1-10, with 1 indicating "not satisfied" and 10 indicating "completely satisfied." RESULTS: Overall, 166 patients were randomized 1:1 in each group. According to the multivariable regression model, the video-assisted informed consent significantly increased the difference between postoperative and preoperative STAI, reducing the level of anxiety. The video-assisted informed consent significantly predicted the number of assistance calls during the hospitalization. CONCLUSIONS: Video-consent for ureteroscopies are a valid tool to improve patients' satisfaction and awareness of the procedure. Video-consent is able to reduce patients' anxiety related to the procedure and assistance calls during the postoperative period, resulting in a useful tool to administer a better-informed consent for endourological procedures.

Skill Transfer from Laparoscopic Partial Nephrectomy to the Hugo™ RAS System: A Novel Proficiency Score to Assess Surgical Quality during the Learning Curve.

Background/Objectives: The absence of validated tools to assess the skill transfer from laparoscopy to robotic surgery remains an unsolved issue in the context of robot-assisted partial nephrectomy (RAPN). We aimed to describe and validate a novel proficiency score to critically evaluate the surgical quality of RAPN with the Hugo™ RAS System (Medtronic, Minneapolis, MN, USA). Methods: Between October 2022 and September 2023, 27 consecutive patients underwent off-clamp RAPN for localized renal tumors at our institution. To analyze the learning curve (LC), the cohort was chronologically divided into two phases of 6 months each. Proficiency was defined as the achievement of trifecta while maintaining a comparable intraoperative time in the interquartile range of laparoscopic partial nephrectomy performed by the same surgeon. A logistic binary regression model was built to identify predictors of proficiency achievement. Results: A proficiency score was achieved in 14 patients (74.1%). At univariable analysis, number of consecutive procedures > 12 (OR 13.7; 95%CI 2.05-21.1, p = 0.007), pathological tumor size (OR 0.92; 95%CI 0.89-0.99, p = 0.04) and essential blood hypertension (OR 0.16; 95%CI 0.03-0.82, p = 0.02) were found to be predictors of proficiency score. At multivariable analysis, after adjusting for potential confounding factors, number of consecutive procedures > 12 (OR 8.1; 95%CI 1.44-14.6, p = 0.03) was the only independent predictor of proficiency score achievement. Conclusions: Our results showed that the skills of an experienced laparoscopic surgeon are transferrable to the novel Hugo™ RAS System in the context of nephron-sparing surgery. Improved surgical quality may be expected after completing the first 12 consecutive procedures.

Trifecta Outcomes of Robot-Assisted Partial Nephrectomy Using the New Hugo™ RAS System Versus Laparoscopic Partial Nephrectomy.

(1) Background: Laparoscopic partial nephrectomy (LPN) is still performed in many referred urological institutions, representing a valid alternative to robot-assisted partial nephrectomy (RAPN). We aimed to compare trifecta outcomes of LPN and RAPN with the Hugo™ RAS System. (2) Methods: Between October 2022 and September 2023, eighty-nine patients underwent minimally invasive partial nephrectomy (group A, RAPN = 27; group B, Laparoscopic PN = 62) for localized renal tumors at our Institution. Continuous variables were presented as median and IQR and compared by means of the Mann-Whitney U test, while categorical variables were presented as frequencies (%) and compared by means of the χ2 test. (3) Results: Group A showed a higher rate of male patients (81.5% vs. 59.7%, p = 0.04) and a higher trend towards larger clinical tumor size (34 vs. 29 mm, p = 0.14). All the other baseline variables were comparable between the two groups (all p > 0.05). Regarding post-operative data, group A displayed a lower operative time (92 vs. 149.5 min, p = 0.005) and a shorter hospital stay (3 vs. 5, p = 0.002). A higher rate of malignant pathology was evidenced in group A (77.8% vs. 58.1%, p = 0.07) as well as a lower trend towards positive surgical margins (3.7% vs. 4.8%, p = 0.82), even if not statistically significant. (4) Conclusions: The rate of trifecta achievement was 92.6% and 82.3% for group A and B (p = 0.10), respectively. In terms of trifecta outcomes, RAPN using the Hugo™ RAS System showed comparable results to LPN performed by the same experienced surgeon.

Is water vapor thermal therapy safe and feasible in elderly and frail men? The Italian experience.

PURPOSE: In recent years, water vapor thermal therapy (WVTT) has spread as minimally invasive technique in lower urinary tract symptoms due to benign prostatic hyperplasia treatment. Even if its safety and feasibility have been largely proved in young men, nobody has proved the same feasibility and safety in the elderly (men older than 75 years old). Our aim is to compare WVTT safety outcomes in men older than 75 with younger men. METHODS: We prospectively collected data on men who underwent water vapor thermal therapy from 2019. We compared data on operative time, number of injections, intra-operative and post-operative complications, reinterventions rate. RESULTS: We enrolled 426 patients; among these, 60 were older than 75 years old, 366 were younger. Our cohorts of patients had similar results in terms of intra-operative and post-operative complications. Operative time accounts about 11 min for both groups (p = 0.535), total number of injections was seven for young men and eight for elderly (p = 0.314). We found no intra-operative complications in elderly men group and only one in the younger group (p = 0.678), while five younger men underwent clot retention, and two elderly men experienced this complication (p = 0.239). Only one transfusion occurred in the elderly group. No differences between groups occurred in terms of length of stay, post-operative urinary retention and reintervention rate, while catheterization time was longer in the elderly men. CONCLUSION: WVTT is a safe procedure in elderly patients with comparable intra-operative and post-operative complication rate in comparison with younger patients.

Laparoscopic versus Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Management after Radical Prostatectomy: Results from a Single Center Study.

(1) Background: Regional anesthesia, achieved through nerve blocks, has gained widespread acceptance as an effective pain management approach. This research aimed to evaluate the efficacy of laparoscopic (LAP) transversus abdominis plane (TAP) block in patients undergoing laparoscopic radical prostatectomy. (2) Methods: From January 2023 to July 2023, 60 consecutive patients undergoing minimally invasive radical prostatectomy were selected. Patients were split into two groups receiving ultrasound-guided (US) or laparoscopic-guided TAP block. The primary outcome was a pain score expressed by a 0-10 visual analog scale (VAS) during the first 72 h after surgery. (3) Results: Both LAP-TAP and US-TAP block groups were associated with lower pain scores postoperatively. No statistically significant differences were observed between the two groups in surgery time, blood loss, time to ambulation, length of stay, and pain after surgery (all p > 0.2). In the LAP-TAP block group, the overall operating room time was significantly shorter than in the US-TAP block group (140 vs. 152 min, p = 0.04). (4) Conclusions: The laparoscopic approach, compared to the US-TAP block, was equally safe and not inferior in reducing analgesic drug use postoperatively. Moreover, the intraoperative LAP-TAP block seems to be a time-sparing procedure that could be recommended when patient-controlled analgesia cannot be delivered.

Robotic Medtronic Hugo™ RAS System Is Now Reality: Introduction to a New Simulation Platform for Training Residents.

The use of robotic surgery (RS) in urology has grown exponentially in the last decade, but RS training has lagged behind. The launch of new robotic platforms has paved the way for the creation of innovative robotics training systems. The aim of our study is to test the new training system from Hugo™ RAS System-Medtronic. Between July 2020 and September 2022, a total of 44 residents from urology, gynaecology and general surgery at our institution participated in advanced robotic simulation training using the Hugo™ RAS simulator. Information about sex, age, year of residency, hours spent playing video games, laparoscopic or robotic exposure and interest in robotics (90.9% declared an interest in robotics) was collected. The training program involved three robotic exercises, and the residents performed these exercises under the guidance of a robotics tutor. The residents' performance was assessed based on five parameters: timing, range of motion, panoramic view, conflict of instruments and exercise completion. Their performance was evaluated according to an objective Hugo system form and a subjective assessment by the tutor. After completing the training, the residents completed a Likert scale questionnaire to gauge their overall satisfaction. The rate of the residents' improvement in almost all parameters of the three exercises between the first and the last attempts was statistically significant (p < 0.02), indicating significant progress in the residents' robotic surgical skills during the training. The mean overall satisfaction score ± standard deviation (SD) was 9.4 ± 1.2, signifying a high level of satisfaction among the residents with the training program. In conclusion, these findings suggest that the training program utilizing the Hugo™ RAS System is effective in enhancing robotic surgical skills among residents and holds promise for the development of standardized robotics training programs in various surgical specialties.

Robot-Assisted Renal Surgery with the New Hugo Ras System: Trocar Placement and Docking Settings.

The current literature relating to the novel HugoTM RAS System lacks consistent data concerning the bedside features of robot-assisted partial nephrectomy (RAPN). To describe the trocar placement and docking settings for RAPN with a three-arm configuration to streamline the procedure with HugoTM RAS, between October 2022 and April 2023, twenty-five consecutive off-clamp RAPNs for renal tumors with the HugoTM RAS System were performed. We conceived a trouble-free three-arm setting to ease and standardize RAPN trocar placement and docking settings with HugoTM RAS. Perioperative data were collected. Post-operative complications were reported according to the Clavien-Dindo classification. The eGFR was calculated according to the CKD-EPI formula. Continuous variables were presented as the median and IQR, while frequencies were reported as categorical variables. Off-clamp RAPNs were successfully performed in all cases without the need for conversion or additional port placement. The median age and BMI were 69 years (IQR, 60-73) and 27.3 kg/m2 (IQR, 25.7-28.1), respectively. The median tumor size and R.E.N.A.L. score were 32.5 mm (IQR, 26-43.7) and 6 (IQR, 5-7), respectively. Two patients were affected by cT2 renal tumors. The median docking and console time were 5 (IQR, 5-6) and 90 min (IQR, 68-135.75 min), respectively, with slightly progressive improvements in the docking time achieved. No intraoperative complications occurred alongside clashes between instruments or with the bed assistant. In experienced hands, this simplified three-instrument configuration of the HugoTM RAS System for off-clamp RAPN resulted in feasible and safe practice, providing patient-tailored trocar placement and docking with non-inferior peri-perioperative outcomes to other robotic platforms.

Predictors of Urinary Continence Recovery after Laparoscopic-Assisted Radical Prostatectomy: Is Surgical Urethral Length the Only Key Factor?

Several efforts in recent years have been made to predict urinary continence (UC) recovery after radical prostatectomy. The aim of our study was to investigate the impact of surgical urethral length preservation (SULP) on urinary continence after LARP (laparoscopic-assisted radical prostatectomy). We retrospectively queried our datasets from May 2021 to May 2022. After the application of exclusion criteria, a total of 100 patients who underwent LARP for prostate cancer at our institution were enrolled. Through a sterile ruler inserted by a 12 mm trocar, the length of the membranous urethra spared during LARP was assessed intra-operatively. The baseline and peri- and postoperative data of patients were collected, and UC was defined as 0 or 1 on a safety pad. The median SULP was 20.5 mm (IQR, 14.5-25), and the median intraoperative EBL were 150 mL (IQR, 100-200). The Kaplan-Meier curve showed a significant difference at 20 mm, which was used as the cut-off value for SULP (log-rank test, p < 0.001). Multivariate Cox proportional hazards models showed that SULP and EBL < 250 mL were associated with UC recovery (all p < 0.02). Surgical urethral length preservation seemed to improve early UC recovery after LARP. Further multicentric studies are needed to confirm our findings.

Video Consensus and Radical Prostatectomy: The Way to Chase the Future?

In the age of information, new platforms are consulted by patients to acquire consciousness about medical treatments. The aim of this study was to assess the level of understanding and feasibility of video consensus (VC) administration in patients scheduled for radical prostatectomy (RP), comparing it with standard informed consensus (SIC). According to the European Association of Urology Patient Information, we set up a video content for RP that was translated in Italian and implemented with information about possible perioperative and postoperative complications, days of hospitalization etc. From 2021 to 2022, all patients undergoing RP at our institution were prospectively included in this study. Patients received an SIC and after that, a VC about RP. After two consensuses were administered, patients received a preformed Likert 10 scale and STAI questionnaires. On the RP dataset, 276 patients were selected and 552 questionnaires for both SIC and VC were evaluated. Out of these, the median age was 62 years (IQR 60-65). Patients reported a higher overall satisfaction for VC (8.8/10) compared to the traditional informed consent (6.9/10). Therefore, VC may play a role in the future of surgery, improving the consciousness and satisfaction of patients and reducing preoperative anxiety.

Impact of Robotic Technologies on Prostate Cancer Patients' Choice for Radical Treatment.

Prostate cancer (PCa) surgery has a strong impact on men's social and sexual lives. For this reason, many patients ask for robotic surgery. To assess the rate of lost patients due to the lack of a robotic platform (RPl) at our center, we retrospectively selected 577 patients who underwent prostate biopsy between 2020 and 2021 who were eligible for radical prostatectomy (RP) (ISUP ≥ 2; age ≤ 70 yr). Patients eligible for surgery who decided to be operated received a phone call interview asking the reason for their choice. Overall, 230 patients (31.7%) underwent laparoscopic-assisted radical prostatectomy (LaRP) at our center, while 494 patients (68.3%) were not treated in our hospital. Finally, 347 patients were included: 87 patients (25.1%) underwent radiotherapy; 59 patients (17%) were already under another urologist's care; 113 patients (32.5%) underwent robotic surgery elsewhere; and 88 patients (25.4%) followed the suggestion of friends or relatives based on their surgical experience. Despite no surgical technique for RP having shown superiority in terms of oncological or functional outcomes, patients eligible for PCa treatment decided to be operated on elsewhere because of the lack of an RPl. Our results show how the presence of an RPl may increase the case volume of RP by 49% at our center.

Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors: the role of combination treatment therapy.

BACKGROUND: While the addition of androgen receptor signaling inhibitors (ARSIs) to androgen deprivation therapy (ADT) results in better of overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC), information regarding health related quality of life (HR-QoL) is sparse. We aimed at summarizing current evidence on the impact of ARSIs on HR-QoL. METHODS: We performed a systematic review of the published literature on PubMed/EMBASE, Web of Science, SCOPUS, and the Cochrane libraries between January 2011 and April 2022. We included only phase III randomized controlled trials (RCT), which were selected according to the PRISMA guidelines. We aimed at evaluating differences in HR-QoL, assessed by validated patient reported outcomes instruments. We analyzed global scores and sub-domains such as sexual functioning, urinary symptoms, bowel symptoms, pain/fatigue, emotional and social/family wellbeing. We reported data descriptively. RESULTS: Six RCTs were included: two used enzalutamide with ADT as intervention arms (ARCHES, ENZAMET); one used apalutamide with ADT (TITAN); two abiraterone acetate and prednisone (AAP) with ADT (STAMPEDE, LATITUDE); and one darolutamide with ADT (ARASENS). Enzalutamide or AAP with ADT increase overall HR-QoL in comparison with ADT alone, ADT with first generation nonsteroideal anti-androgens or ADT with docetaxel, whereas apalutamide and darolutamide with ADT maintain HR-QoL similarly to ADT alone or ADT with docetaxel, respectively. Time to first deterioration of pain was longer with combination therapy with enzalutamide, AAP or darolutamide, but not with apalutamide. No worsening of emotional wellbeing was reported from the addition of ARSIs to ADT than ADT alone. CONCLUSIONS: The addition of ARSIs to ADT in mHSPC tends to increase overall HR-QoL and prolong time to first deterioration of pain/fatigue compared with ADT alone, ADT with first generation nonsteroideal anti-androgens, and ADT with docetaxel. ARSIs show a complex interaction with remaining HR-QoL domains. We advocate a standardization of HR-QoL measurement and reporting to allow further comparisons.

Real-Time Urethral and Ureteral Assessment during Radical Cystectomy Using Ex-Vivo Optical Imaging: A Novel Technique for the Evaluation of Fresh Unfixed Surgical Margins.

BACKGROUND: Our study aims to assess the feasibility and the reproducibility of fluorescent confocal microscopy (FCM) real-time assessment of urethral and ureteral margins during open radical cystectomy (ORC) for bladder cancer (BCa). METHODS: From May 2020 to January 2022, 46 patients underwent ORC with intraoperative FCM evaluation. Each specimen was intraoperatively stained for histopathological analysis using FCM, analyzed as a frozen section (FSA), and sent for traditional H&E examination. Sensitivity, specificity, positive predictive value (PPV), and the negative predictive value (NPV) of FCM and FSA were assessed and compared with H&E for urethral and ureteral margins separately. RESULTS: The agreement was evaluated through Cohen's κ statistic. Urethral diagnostic agreement between FCM and FSA showed a κ = 0.776 (p < 0.001), while between FCM and H&E, the agreement was κ = 0.691 (p < 0.001). With regard to ureteral margins, an overall agreement of κ = 0.712 (p < 0.001) between FCM and FSA and of κ = 0.481 (p < 0.001) between FCM and H&E was found. CONCLUSIONS: FCM proved to be a safe, feasible, and reproducible method for the intraoperative assessment of urethral and ureteral margins during ORC. Compared to standard FSA, FCM showed adequate diagnostic performance in detecting urethral and ureteral malignant involvement.

Radiomic Machine-Learning Analysis of Multiparametric Magnetic Resonance Imaging in the Diagnosis of Clinically Significant Prostate Cancer: New Combination of Textural and Clinical Features.

BACKGROUND: The aim of our study was to develop a radiomic tool for the prediction of clinically significant prostate cancer. METHODS: From September 2020 to December 2021, 91 patients who underwent magnetic resonance imaging prostate fusion biopsy at our institution were selected. Prostate cancer aggressiveness was assessed by combining the three orthogonal planes-Llocal binary pattern the 3Dgray level co-occurrence matrix, and other first order statistical features with clinical (semantic) features. The 487 features were used to predict whether the Gleason score was clinically significant (≥7) in the final pathology. A feature selection algorithm was used to determine the most predictive features, and at the end of the process, nine features were chosen through a 10-fold cross validation. RESULTS: The feature analysis revealed a detection accuracy of 83.5%, with a clinically significant precision of 84.4% and a clinically significant sensitivity of 91.5%. The resulting area under the curve was 80.4%. CONCLUSIONS: Radiomic analysis allowed us to develop a tool that was able to predict a Gleason score of ≥7. This new tool may improve the detection rate of clinically significant prostate cancer and overcome the limitations of the subjective interpretation of magnetic resonance imaging, reducing the number of useless biopsies.

Transurethral Resection of Bladder Tumor: Electrosurgical and Laser.

Transurethral resection of bladder tumor (TURBT) is still the gold standard for the diagnosis, treatment, and staging of nonmuscle invasive bladder cancer. En bloc resection of bladder tumor (EBRT) has been recently introduced to overcome the limitations of conventional TURBT. EBRT potential advantages are (1) complete resection, (2) a more precise and controlled resection (potentially fewer complications), (3) better sample orientation for histopathology analysis, (4) presence of detrusor in the specimen, and (5) less tumor seeding on normal urothelium by tumor fragments. This article aimed to present a step-by-step technique of conventional TURBT and EBRT with thulium laser support. We also aimed to provide tips and tricks for a correct surgical procedure and postoperative patient care. Finally, clinical outcomes of TURBT versus EBRT were reviewed.

Does Exist a Differential Impact of Degarelix Versus LHRH Agonists on Cardiovascular Safety? Evidences From Randomized and Real-World Studies.

The main systemic therapy for the management of hormone-sensitive prostate cancer (PC) is androgen deprivation therapy (ADT), with the use of long-acting luteinizing hormone releasing-hormone (LHRH) agonists considered the main form of ADT used in clinical practice to obtain castration in PC. The concomitant administration of antiandrogens for the first weeks could reduce the incidence of clinical effects related to the testosterone flare-up in the first injection of LHRH. On the contrary, Gonadotropin Rh (GnRH) antagonists produce a rapid decrease of testosterone levels without the initial flare-up, with degarelix commonly used in clinical practice to induce castration in PC patients. Even if no long-term data are reported in terms of survival to define a superiority of GnRH or LHRH, for oncological efficacy and PC control, data from randomized clinical trials and from real-life experiences, suggest a difference in cardiovascular risk of patients starting ADT. The age-related decline in testosterone levels may represent a factor connected to the increase of cardiovascular disease risk, however, the role of ADT in increasing CV events remains controversial. For these reasons, the aim of the paper is to synthesize the difference in cardiovascular risk between LHRH and degarelix in patients undergoing ADT. A difference in cardiovascular risk could be indeed an important parameter in the evaluation of these two forms of castration therapy. The Randomized trials analyzed in this paper sustain a possible protective role for degarelix versus LHRH agonists in reducing the rate of new CV events and interventions in the short-term period. On the contrary, real-word data are contradictory in different national experiences and are strongly conditioned by huge differences between the LHRH agonists group and the degarelix group.

Neutrophil percentage-to-albumin ratio predicts mortality in bladder cancer patients treated with neoadjuvant chemotherapy followed by radical cystectomy.

AIM: To investigate the prognostic role of neutrophil percentage-to-albumin ratio (NPAR) in muscle-invasive bladder cancer (MIBC) patients treated with neoadjuvant chemotherapy (NAC) and radical cystectomy (RC). PATIENTS & METHODS: 213 patients were included. INCLUSION CRITERIA: Nonmetastatic, MIBC (cT2-T4aN0M0), at least three cycles of NAC, undergone RC and with blood count within 30 days before NAC. RESULTS: Five-years overall survival (OS) with NPAR >18 was 34.06% (95% CI: 18.3-50.5) and 65.37% (95% CI: 52.4-75.6) with NPAR <18. Five years cancer-specific survival (CSS) with NPAR >18 was 42.9% (95% CI: 23.9-60.7) and 74.5% (95% CI: 62.6-83.1) with NPAR <18 (p < 0.001). In multivariable analysis, NPAR increased OS of 1.3 points and CSS of 4.37 points. CONCLUSION: High NPAR prior to NAC seems to be a strong predictor of OS and CSS in MIBC patients treated with NAC and RC.

Urology practice during the COVID-19 vaccination campaign.

INTRODUCTION: The current scenario of the COVID-19 pandemic is significantly different from that of the first, emergency phase. Several countries in the world are experiencing a second, or even a third, wave of contagion, while awaiting the effects of mass vaccination campaigns. The aim of this report was to provide an update of previously released recommendations on prioritization and restructuring of urological activities. METHODS: A large group of Italian urologists directly involved in the reorganization of their urological wards during the first and second phase of the pandemic agreed on a set of updated recommendations for current urology practice. RESULTS: The updated recommendations included strategies for the prioritization of both surgical and outpatient activities, implementation of perioperative pathways for patients scheduled for elective surgery, management of urological conditions in infected patients. Future scenarios with possible implementation of telehealth and reshaping of clinical practice following the effects of vaccination are also discussed. CONCLUSION: The present update may be a valid tool to be used in the clinical practice, may provide useful recommendations for national and international urological societies, and may be a cornerstone for further discussion on the topic, also considering further evolution of the pandemic after the recently initiated mass vaccination campaigns.

New Technologies for Kidney Surgery Planning 3D, Impression, Augmented Reality 3D, Reconstruction: Current Realities and Expectations.

PURPOSE OF REVIEW: We aim to summarize the current state of art about 3D applications in urology focusing on kidney surgeries. In addition we aim to provide a snapshot about future perspective of intraoperative applications of augmented reality (AR). RECENT FINDINGS: A variety of applications in different fields have been proposed. Many applications concern current realities and 3D reconstruction, while some others are about future perspective. The majority of recent studies have focused their attention on preoperative surgical planning, patient education, surgical training, and AR. The disposability of 3D models in healthcare scenarios might improve surgical outcomes, learning curves of novice surgeons and residents, as well as patients' understanding and compliance, allowing a more shared surgical decision-making.

Role of fluorescence confocal microscopy for rapid evaluation of EUS fine-needle biopsy sampling in pancreatic solid lesions.

BACKGROUND AND AIMS: EUS fine-needle biopsy (EUS-FNB) sampling is the standard procedure for diagnosis of pancreatic lesions. Fluorescence confocal microscopy (FCM) allows imaging of tissues in the fresh state, requiring minimal preparation without damage or loss of tissue. Until now, no data exist on FCM in the field of microhistologic specimens. We aimed to assess the diagnostic performance of FCM in predicting histologic adequacy of EUS-FNB samples in pancreatic solid lesions and to assess the agreement between FCM evaluation and final histology. METHODS: In this single-center prospective study on consecutive patients with pancreatic lesions receiving EUS-FNB, the obtained samples have been evaluated at FCM and classified as "inadequate" or "adequate" (benign, suspicious, or malignant). The kappa test was used to quantify agreement. The diagnostic accuracy of FCM was assessed. A P < .05 was considered to be statistically significant. RESULTS: From April 2020 to September 2020, 81 patients were enrolled. In all cases FCM showed the macro image of the sample and created a digital image. Of the samples, 92.6% was defined as adequate at the FCM evaluation and confirmed at histopathology. Histologic diagnoses were 8% benign, 17.3% atypical/suspicious, and 74.7% malignant with satisfactory agreement with the FCM evaluation (Cohen's κ coefficient, .95; 95% confidence interval [CI], .89-1.01; P = .001). The sensitivity of the FCM evaluation was 100% (95% CI, 95%-100%), specificity 66.7% (95% CI, 22.3%-95.7%), accuracy 97% (95% CI, 90.7%-99.7%), positive predictive value 97% (95% CI, 91.8%-99%), and negative predictive value 100%. CONCLUSIONS: FCM represents a new technique successfully applicable to microhistologic specimens. It provides fast information about sample adequacy in small specimens with good agreement in the final histology.