Prospective evaluation of core number of biopsy for renal tumor: are multiple cores preferable?

PURPOSE: This single-center, single-arm, prospective, open-label study was conducted to evaluate the optimal number of cores (single or multiple) in renal tumor biopsy. MATERIALS AND METHODS: Forty-four biopsies of 44 tumors (mean diameter, 2.7 ± 1.0 cm; range, 1.6-5.0 cm) were included. Biopsy was performed under ultrasound or computed tomography fluoroscopy guidance using an 18-gauge cutting needle and the co-axial method. Two or more specimens were obtained, which were divided into first and subsequent specimens. "First specimen" and "all specimens" were histologically evaluated (i.e., appropriateness of specimen, histological diagnosis, subtype, and Fuhrman grade of renal cell carcinoma [RCC]) blindly and independently by two board-certified pathologists. RESULTS: Multiple specimens were successfully and safely obtained in all the biopsies. All tumors were histologically diagnosed; 40 malignancies included 39 RCCs and 1 solitary fibrous tumor, and 4 benign lesions included 2 angiomyolipomas, 1 oncocytoma, and 1 capillary hemangioma. In all RCCs, the subtype could be determined (32 clear cell RCCs, 4 chromophobe RCCs, and 3 papillary RCCs), and the Furman grade was determined in 38 RCCs. When only the first specimen was evaluated, 22.7% of the specimens were inappropriate for diagnosis, and 34 (77.3%) were histologically diagnosed. The diagnostic yield was significantly lower than that of all specimens (P = 0.0044). Univariate analysis revealed that smaller lesions were a significant predictor of diagnostic failure (P = 0.020). CONCLUSION: Biopsy with multiple cores significantly improved diagnostic yield. Thus, operators should obtain multiple cores during renal tumor biopsy.

Percutaneous cryoablation combined with prior transcatheter arterial embolization for renal cell carcinomas of 3 cm or larger: a prospective study.

BACKGROUND: We prospectively evaluated the safety and efficacy of percutaneous cryoablation combined with transcatheter renal arterial embolization for the treatment of tumors ≥ 3 cm in diameter. METHODS: We included patients aged ≥ 20 years with histologically proven renal cell carcinoma with a tumor diameter ≥ 3 cm who were inoperable or refused surgery. Prior to ablation, transcatheter arterial embolization was performed using a mixture of absolute ethanol and iodized oil. All cryoablation procedures were performed percutaneously under computed tomography fluoroscopy guidance. The primary endpoint was safety, which was evaluated for adverse events using CTCAE version 4.0. The secondary endpoint was survival; overall survival, progression-free survival, and cancer-specific survival were calculated. RESULTS: From October 2013 to March 2016, 19 patients (mean age, 75 ± 13 years; 5 women, 14 men) were prospectively enrolled. The mean tumor diameter was 3.9 ± 0.7 (range 3.1-5.3) cm. Four grade 3 hematologic adverse events occurred, while no symptomatic grade ≥ 3 events occurred. The median follow-up period was 68 (range 52-84) months. During the follow-up period, two patients developed local tumor progression at 3 and 42 months after the initial ablative procedure; no patient showed distant metastasis. Two patients died from causes other than RCC. Overall survival, progression-free survival, and cause-specific survival were 100%, 95%, and 100% at 3 years, and 95%, 84%, and 100% at 5 years, respectively. CONCLUSION: Percutaneous cryoablation combined with prior TAE for the treatment of tumors ≥ 3 cm in diameter was safe and achieved favorable survival.

Early enlarging cavitation after percutaneous radiofrequency ablation of lung tumors: Incidence, risk factors and outcome.

PURPOSE: The purpose of this study was to retrospectively determine the incidence of early enlarging cavitation after percutaneous radiofrequency ablation (RFA) of lung tumor and identify risk factors associated with their occurrence. PATIENTS AND METHODS: A total of 245 patients (140 men, 105 women; mean age, 62.7 ± 11.8 [SD] years; age range: 31-87 years) with 605 lung tumors who were treated using 401 RFA sessions from April 2010 to March 2020 were included. Of which, 31 patients with 38 early enlarging cavitation and control group (151 patients with 228 tumors) were analyzed. Early enlarging cavitation was defined as cavities with an enlarged size (>3 cm) occurring on ablated lesions within seven days after RFA. Incidence of cavitation, risk and post-procedural factors of occurrence, major adverse events (AEs) that occurred in RFA sessions with cavitation, and course of cavitation were evaluated. AEs were classified using the CIRSE classification system for complications. RESULTS: Thirty-eight cavities (6.3%, 38/605 tumors) in 31 patients occurred in an average of 3.1 ± 1.7 days (range, 1-7 days) after 32 RFA sessions. Distance from pleura ≥ 20 mm, contact with vessel ≥ 3 mm, multitined expandable electrode ≥ 3 cm, and bronchus ≥ 2 mm encompassed in the ablation zone were independent risk factors of occurrence. Fever ≥ 38.5 °C, white blood cell count ≥ 10,000/µl one day after RFA, and steroid therapy were independent post-procedural factors of occurrence. Twenty-four Grade 3 and two Grade 6 AEs occurred. Twenty-nine cavities disappeared within a mean duration of 111.9 ± 64.9 (SD) days (range: 44-274 days) and four remained with a mean follow-up of 279.2 ± 174 (SD) days; five patients were lost to follow-up. CONCLUSIONS: Early enlarging cavitation occurs in 6.3% of lung tumors treated with RFA and are associated with 26 major AEs in 32 sessions. Aforementioned procedural factors and post-procedural inflammation were significant risk factors of occurrence.

Percutaneous needle biopsy under 1.2 Tesla open MRI guidance.

PURPOSE: To evaluate the feasibility of percutaneous needle biopsy using a 1.2 Tesla open magnetic resonance imaging (MRI) system, which has the highest field strength among the currently available open MRI systems. MATERIALS AND METHODS: This single-center prospective study included 10 patients. The primary endpoint was the feasibility of biopsy needle insertion into a target lesion under 1.2 Tesla open MRI guidance. The secondary endpoints included adverse events, device failures, and success of tissue specimen acquisition. Biopsy was performed for targets in various organs using an MRI-compatible coaxial needle system consisting of a 16G introducer needle and 18G semi-automatic biopsy needle. A newly developed body coil with a suitable design for intervention was used for intraprocedural imaging. RESULTS: Biopsy procedures were performed for six musculoskeletal masses, two retroperitoneal masses, one renal mass, and one liver mass. The median diameter of the targets was 4.9 cm (range 2.1-22.8 cm). MRI-guided biopsy needle insertion was feasible in all 10 patients. In total, four grade 1 adverse events (as per Common Terminology Criteria for Adverse Events version 4.0) occurred in three patients. Adequate biopsy specimens for pathological diagnosis were successfully obtained from all 10 patients. CONCLUSION: Percutaneous needle biopsy using a 1.2 Tesla open MRI system was feasible for relatively large targets, especially in the musculoskeletal region.

JME-001 phase II trial of first-line combination chemotherapy with cisplatin, pemetrexed, and nivolumab for unresectable malignant pleural mesothelioma.

BACKGROUND: JME-001 is a phase II trial assessing the efficacy and safety of cisplatin, pemetrexed, and nivolumab as first-line therapy in malignant pleural mesothelioma (MPM). PATIENTS AND METHODS: Patients with untreated, unresectable MPM with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 were included. The primary endpoint is the centrally reviewed objective response rate. The secondary endpoints include (1) response rate assessed by investigators, (2) disease control rate, (3) overall survival, (4) progression-free survival, (5) duration of response, and (6) time to response. Safety and adverse events will also be evaluated. Cisplatin (75 mg/m2), pemetrexed (500 mg/m2), and nivolumab (360 mg/body) were administered intravenously every 3 weeks with a total of 4-6 cycles. If patients did not progress during the combination phase, maintenance therapy with nivolumab was administered until disease progression or unacceptable toxicity. Tissue samples were required and collected for programmed death ligand 1 analysis. RESULTS: Eighteen patients (mean age 69.2 years, 15 men) were enrolled between January 2018 and May 2019. The ECOG PS was 0 in 3 patients and 1 in 15 patients. Fourteen (77.8%; 95% CI 52.4% to 93.6%) patients had an objective response. The disease control rate was 94.4% (95% CI 72.7% to 99.9%). Fourteen (77.8%) patients had partial response (PR), three had stable disease, and one was not evaluable. Tumor shrinkage was observed in 10/14 (71.4%) patients with epithelioid, and 2/2 (100%) patients with sarcomatoid or biphasic histological subtype had PR. Ten (55.6%) patients experienced grade 3 or worse adverse events, including disorder of metabolism or nutrition (33.3%), loss of appetite (27.8%), anemia (16.7%), and hyponatremia (11.1%). No treatment-related deaths occurred. CONCLUSIONS: The safety and efficacy of this study strongly support a definitive trial of this combination.Trial registration numberUMIN000030892.

Study protocol for endoscopic ultrasonography-guided ethanol injection therapy for patients with pancreatic neuroendocrine neoplasm: a multicentre prospective study.

INTRODUCTION: The management of small pancreatic neuroendocrine neoplasms (PNENs) remains controversial. The standard treatment for PNENs is surgical resection; however, invasiveness of surgical procedure remains higher and the incidence of postoperative adverse events is still high. Recently, the efficacy and safety of endoscopic ultrasonography (EUS)-guided ethanol injection for small PNENs has been preliminarily demonstrated. Thus, a multicentre prospective study is being conducted to evaluate the efficacy and safety of EUS-guided ethanol injection therapy for small PNENs. METHODS AND ANALYSIS: The major eligibility criteria are the presence of pathologically diagnosed grade (G) 1 tumour, a tumour size of ≤15 mm and non-functional PNEN or insulinoma. For treatment, we will use a 25-gauge needle and pure ethanol. Contrast-enhanced CT (CE-CT) will be performed on postoperative day 3-5, and if enhanced areas of the tumour are still apparent, an additional session is scheduled during the same hospitalisation period. We set the total amount of ethanol per session to 2 mL. To evaluate the efficacy and safety, CE-CT will be performed at 1 and 6 months after treatment. The primary endpoint is the percentage of subjects who achieved all of the following evaluated points. Efficacy will be evaluated based on the achievement of complete ablation (defined as no enhanced area within the tumour on CE-CT) at 1 and 6 months. Safety will be evaluated based on the avoidance of severe adverse events within 1 month after treatment, continuing severe pancreatic fistula at 1 month after treatment and the incidence and/or exacerbation of diabetes mellitus at 6 months after treatment. ETHICS AND DISSEMINATION: This protocol has been approved by Okayama University Certified Review Board (approval number. CRB19-007). The results will be submitted to peer-reviewed journals and will be presented at international conferences. TRIAL REGISTRATION NUMBER: jRCTs061200016.

Percutaneous Cryoablation of Lower Limb Soft-Tissue Venous Malformations: Preliminary Results of Long-Term Efficacy.

PURPOSE: To retrospectively evaluate long-term efficacy of percutaneous cryoablation for lower limb soft-tissue venous malformations. MATERIALS AND METHODS: Nine patients (mean age, 36.6 years) with lower limb soft-tissue venous malformations were included. Cryoablation was performed percutaneously using an argon-based system. Adverse events (AE) using the Common Terminology Criteria for AEs version 4.0 were evaluated. The visual analog scale (VAS) scores and lesion volumes measured on magnetic resonance imaging were also evaluated at 12 months and 5-6 years. RESULTS: Technical success (i.e., complete coverage of the lesion by an iceball) was achieved in eight of the nine patients. All patients developed a total of 14 grade 1 or 2 adverse events. The mean (± standard deviation) VAS score was 6.0 (± 1.7) before therapy, whereas it was 0.14 (± 0.27) at 12 months and 0.97 (± 1.3) at 5-6 years (58-78 months). Complete pain relief was obtained in 6 and 5 patients at 12 months and 5-6 years, respectively. The median lesion volume was 2.49 mL before therapy, whereas it was 0.26 mL at 12 months and 0.35 mL at 5-6 years. CONCLUSION: Percutaneous cryoablation of lower limb soft-tissue venous malformations achieved considerable pain relief and lesion shrinkage for 5-6 years in this small preliminary study. LEVEL OF EVIDENCE: Level 4, Case Series.

Oncologic outcomes and safety of percutaneous cryoablation for biopsy-proven renal cell carcinoma up to 4 cm in diameter: a prospective observational study.

BACKGROUND: Percutaneous cryoablation is widely used for the treatment of renal cell carcinoma. We prospectively evaluated the oncologic outcomes and safety of percutaneous cryoablation for the treatment of tumors ≤ 4 cm in diameter. METHODS: We included patients aged ≥ 20 years, who had histologically proven renal cell carcinoma, tumor diameter ≤ 4 cm, a performance status of ≤ 1, acceptable laboratory parameters, were inoperable or refused to undergo surgery, and had signed a written informed consent. The primary endpoint was the cause-specific survival rate. The secondary endpoints were overall and progression-free survival, and adverse event frequency and grade. All procedures were percutaneously performed under computed tomography fluoroscopy guidance. RESULTS: From October 2013 to October 2015, 33 patients (mean age: 68 ± 14 years; sex: six women, 27 men) were enrolled. The mean tumor diameter was 2.1 ± 0.6 (range 1.0-3.4) cm. The median follow-up period was 60.1 (range 18.4-76.6) months. One patient died of non-renal cell carcinoma-related disease 46 months after percutaneous cryoablation. The cause-specific and overall survival rates were 100% and 96.8% at 3 years, and 100% and 96.8% at 5 years, respectively. There was no local tumor progression or distant metastasis. The incidence of severe urological (urinary fistula and perinephric infection) and non-urological adverse events (increased creatine kinase and skin ulceration) was 6% each. CONCLUSION: Percutaneous cryoablation for renal cell carcinoma ≤ 4 cm in diameter achieved good tumor control with a low complication frequency.

A Clinical Study Evaluating an Aspiration-type Semi-Automatic Cutting Biopsy Needle (SCIRO-1702).

An aspiration-type semi-automatic cutting biopsy needle enables tissue cutting during application of negative pressure, which is expected to contribute to a larger amount of specimen. The aim of the present study was to evaluate this novel needle in a clinical setting. Patients who underwent image-guided percutaneous biopsy for lung or renal masses were enrolled. Cutting biopsy was performed with and without aspiration during each procedure. The specimens were weighed using an electronic scale. The weights were compared between specimens obtained with and without aspiration using a paired t-test. The data from 45 lung and 30 renal biopsy procedures were analyzed. In lung biopsy, the mean±standard deviation weights of specimens obtained with and without aspiration were 2.20±1.05 mg and 2.24±1.08 mg, respectively. In renal biopsy, the mean weights were 6.52±2.18 mg and 6.42±1.62 mg, respectively. The weights were not significantly different between specimens obtained with and without aspiration either in lung (p=0.799) or renal (p=0.789) biopsies. The application of negative pressure with the aspiration-type semi-automatic cutting biopsy needle did not contribute to an increase in the amount of the specimen obtained in lung and renal biopsies.

Survival Outcomes of Treatment with Radiofrequency Ablation, Stereotactic Body Radiotherapy, or Sublobar Resection for Patients with Clinical Stage I Non-Small-Cell Lung Cancer: A Single-Center Evaluation.

PURPOSE: To retrospectively compare the outcomes of radiofrequency (RF) ablation, stereotactic body radiotherapy (SBRT), and sublobar resection (SLR) in patients with stage I non-small-cell lung cancer (NSCLC) at a single center. MATERIALS AND METHODS: Overall, 289 patients (38 RF ablation, 58 SBRT, and 193 SLR) were included. Kaplan-Meier curves were generated, multiple propensity score was estimated using a multinomial logistic regression model, and relationships between treatments and outcomes were assessed using a Cox proportional hazard model. Hazard ratios (HRs) for death from any cause and disease progression or death from any cause were examined by a crude model, an inverse probability of treatment weighting (IPTW) model, and an IPTW model adjusted for missing variables. RESULTS: The 5-year overall and progression-free survival rates were 58.9% and 39.9%, respectively, for RF ablation; 42.0% and 34.9%, respectively, for SBRT; and 85.5% and 75.9%, respectively, for SLR. Significantly longer survival time and lower HR were observed for SLR than other treatments. However, after statistical adjustment, these relationships were not significant except for reduced HR of disease progression or death from any cause of SLR compared to RF ablation in the IPTW model. The median hospital stays for RF ablation, SBRT, and SLR were 6.5, 6, and 16 days, respectively. Adverse events of grade 3 or higher occurred only in 11 SLR cases. CONCLUSIONS: SLR achieved the longest survival. However, after statistical adjustment, there were no significant outcome differences among RF ablation, SBRT, and SLR, except for 1 model. RF ablation or SBRT may be alternative treatments for selected patients with early-stage NSCLC.

Radiofrequency Ablation for Stage I Non-Small Cell Lung Cancer: An Updated Review of Literature from the Last Decade.

This review summarizes the current findings on radiofrequency ablation (RFA) for stage I non-small cell lung cancer (NSCLC) from relevant literature published in the last decade. While most earlier studies included small populations and had short follow-up periods, more robust data have become available owing to prospective or large cohort studies. The reported overall survival rates after RFA for stage I NSCLC were 83-96%, 40-74%, and 23-61% at 1, 3, and 5 years, respectively, in recent studies. Furthermore, many comparative studies on the outcomes of RFA and stereotactic body radiotherapy have been performed. Most of these studies report no significant difference in survival outcomes between the therapies. Currently, major guidelines define RFA as a reasonable alternative treatment for stage I NSCLC in non-surgical candidates.

Robotic needle insertion during computed tomography fluoroscopy-guided biopsy: prospective first-in-human feasibility trial.

INTRODUCTION: This was a prospective, first-in-human trial to evaluate the feasibility and safety of insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy in humans. MATERIALS AND METHODS: Eligible patients were adults with a lesion ≥ 10 mm in an extremity or the trunk requiring pathological diagnosis with CT fluoroscopy-guided biopsy. Patients in whom at-risk structures were located within 10 mm of the scheduled needle tract were excluded. Ten patients (4 females and 6 males; mean [range] age, 72 [52-87] years) with lesions (mean [range] maximum diameter, 28 [14-52] mm) in the kidney (n = 4), lung (n = 3), mediastinum (n = 1), adrenal gland (n = 1), and muscle (n = 1) were enrolled. The biopsy procedure involved robotic insertion of a biopsy introducer needle followed by manual acquisition of specimens using a biopsy needle. The patients were followed up for 14 days. Feasibility was defined as the distance of ≤ 10 mm between needle tip after insertion and the nearest lesion edge on the CT fluoroscopic images. The safety of robotic insertion was evaluated on the basis of machine-related troubles and adverse events according to the Clavien-Dindo classification. RESULTS: Robotic insertion of the introducer needle was feasible in all patients, enabling pathological diagnosis. There was no machine-related trouble. A total of 11 adverse events occurred in 8 patients, including 10 grade I events and 1 grade IIIa event. CONCLUSION: Insertion of biopsy introducer needles with our robot was feasible at several locations in the human body. KEY POINTS: • Insertion of biopsy introducer needles with our robot during CT fluoroscopy-guided biopsy was feasible at several locations in the human body.

Post-ablation syndrome after percutaneous cryoablation of small renal tumors: A prospective study of incidence, severity, duration, and effect on lifestyle.

PURPOSE: To prospectively investigate the incidence, severity, duration, and effect on lifestyle of post-ablation syndrome (PAS) after percutaneous renal cryoablation. MATERIALS AND METHODS: We enrolled 39 patients (27 male and 12 female; mean age, 62 years) who underwent 40 CT-guided cryoablation sessions for pathologically proven renal cancer (mean size, 20 mm) between December 2015 and December 2017. Four symptoms attributable to PAS, i.e., fever, nausea, vomiting, malaise, and the synergistic effect of these symptoms on lifestyle by 21 days after ablation were evaluated using a questionnaire. Symptoms were graded according to the common toxicity criteria of adverse events. RESULTS: The incidences of fever, nausea, vomiting, and malaise were 100% (40/40), 20% (8/40), 20% (8/40), and 63% (25/40), respectively. Most (78/81, 96%) symptoms had begun by day 2. The highest grade of fever per session was 0 (defined as ≥37.0 °C and <38.0 °C) (n = 24), 1 (n = 15), or 2 (n = 1); that of nausea was 2 (n = 8); that of vomiting was 1 (n = 7) or 3 (n = 1); and that of malaise was 1 (n = 14) or 2 (n = 11). Most (76/81, 94%) symptoms had resolved by day 8. The average values for the maximum scores of interference with general activity and work were 3.6 and 1.1, respectively. CONCLUSION: All symptoms were generally early-onset and self-limiting, with minimal impact on lifestyle and resolution by day 8. The clinical course and impact of PAS should be acknowledged by practitioners who manage patients undergoing renal cryoablation.

Robotic CT-guided out-of-plane needle insertion: comparison of angle accuracy with manual insertion in phantom and measurement of distance accuracy in animals.

OBJECTIVES: To evaluate the accuracy of robotic CT-guided out-of-plane needle insertion in phantom and animal experiments. METHODS: A robotic system (Zerobot), developed at our institution, was used for needle insertion. In the phantom experiment, 12 robotic needle insertions into a phantom at various angles in the XY and YZ planes were performed, and the same insertions were manually performed freehand, as well as guided by a smartphone application (SmartPuncture). Angle errors were compared between the robotic and smartphone-guided manual insertions using Student's t test. In the animal experiment, 6 robotic out-of-plane needle insertions toward targets of 1.0 mm in diameter placed in the kidneys and hip muscles of swine were performed, each with and without adjustment of needle orientation based on reconstructed CT images during insertion. Distance accuracy was calculated as the distance between the needle tip and the target center. RESULTS: In the phantom experiment, the mean angle errors of the robotic, freehand manual, and smartphone-guided manual insertions were 0.4°, 7.0°, and 3.7° in the XY plane and 0.6°, 6.3°, and 0.6° in the YZ plane, respectively. Robotic insertions in the XY plane were significantly (p < 0.001) more accurate than smartphone-guided insertions. In the animal experiment, the overall mean distance accuracy of robotic insertions with and without adjustment of needle orientation was 2.5 mm and 5.0 mm, respectively. CONCLUSION: Robotic CT-guided out-of-plane needle insertions were more accurate than smartphone-guided manual insertions in the phantom and were also accurate in the in vivo procedure, particularly with adjustment during insertion. KEY POINTS: • Out-of-plane needle insertions performed using our robot were more accurate than smartphone-guided manual insertions in the phantom experiment and were also accurate in the in vivo procedure. • In the phantom experiment, the mean angle errors of the robotic and smartphone-guided manual out-of-plane needle insertions were 0.4° and 3.7° in the XY plane (p < 0.001) and 0.6° and 0.6° in the YZ plane (p = 0.65), respectively. • In the animal experiment, the overall mean distance accuracies of the robotic out-of-plane needle insertions with and without adjustments of needle orientation during insertion were 2.5 mm and 5.0 mm, respectively.

MRI-guided percutaneous needle biopsy with 1.2T open MRI: study protocol for a prospective feasibility study (SCIRO-1701).

There has been growing interest in magnetic resonance imaging (MRI)-guided interventional procedures such as percutaneous needle biopsy. Although open MRI is preferable for MRI-guided procedures in terms of patient accessibility, its inferior imaging capability due to lower field strength is a substantial limitation. In this situation, the high-field (1.2T) open MRI has recently become available. This novel MRI system is expected to provide excellent image quality as well as good patient accessibility, potentially contributing to safe and accurate device manipulation. This trial is designed to investigate the feasibility of MRI-guided percutaneous needle biopsy with this system. Patients with lesions needing percutaneous needle biopsy for pathological diagnosis are included. The enrollment of ten patients is intended. The primary endpoint of this study is the feasibility of biopsy needle insertion under real-time MR-fluoroscopy guidance based on the presence of the notch of the biopsy needle within the target lesion. The secondary endpoints are adverse events, device failures, and success of specimen acquisition. Once the feasibility of MRI-guided biopsy with 1.2T open MRI is validated by this study, it may potentially encourage widespread use of MRI-guidance for biopsy procedures. Furthermore, it may lead to development of the other MRI-guided interventional procedures using this MRI system.

Zerobot®: A Remote-controlled Robot for Needle Insertion in CT-guided Interventional Radiology Developed at Okayama University.

Since 2012, we have been developing a remote-controlled robotic system (Zerobot®) for needle insertion during computed tomography (CT)-guided interventional procedures, such as ablation, biopsy, and drainage. The system was designed via a collaboration between the medical and engineering departments at Okayama University, including various risk control features. It consists of a robot with 6 degrees of freedom that is manipulated using an operation interface to perform needle insertions under CT-guidance. The procedure includes robot positioning, needle targeting, and needle insertion. Phantom experiments have indicated that robotic insertion is equivalent in accuracy to manual insertion, without physician radiation exposure. Animal experiments have revealed that robotic insertion of biopsy introducer needles and various ablation needles is safe and accurate in vivo. The first in vivo human trial, therefore, began in April 2018. After its completion, a larger clinical study will be conducted for commercialization of the robot. This robotic procedure has many potential advantages over a manual procedure: 1) decreased physician fatigue; 2) stable and accurate needle posture without tremor; 3) procedure automation; 4) less experience required for proficiency in needle insertion skills; 5) decreased variance in technical skills among physicians; and 6) increased likelihood of performing the procedure at remote hospitals (i.e., telemedicine).

Sex differences in associations among metabolic syndrome, obesity, related biomarkers, and colorectal adenomatous polyp risk in a Japanese population.

To investigate sex differences in the associations among metabolic syndrome, obesity, adipose tissue-related biomarkers, and colorectal adenomatous polyps, a cross-sectional, multicenter study was conducted on 489 consecutive individuals who underwent their first colonoscopy at 3 hospitals. Plasma concentrations of adiponectin and leptin, as well as homeostatic model assessment of insulin resistance were also evaluated. The presence and number of adenomatous polyps, including advanced adenoma, were higher in men than in women. Metabolic syndrome was a risk factor for adenomatous polyps in both sexes. Large waist circumference was an independent risk factor for adenomatous polyps in men, and high BMI and large waist circumference were risk factors for adenomatous polyps in women. Interestingly, low BMI was associated with large adenomatous polyps (≥10 mm) and advanced adenoma, and waist-hip ratio was involved in proximal adenomatous polyp development only in women. In contrast, the highest quartile of leptin concentration had a 3.67-fold increased adenomatous polyp risk compared with the lowest quartile only in men. These results indicate that regarding colorectal pathogenesis, sex differences were identified in obesity but not in metabolic syndrome. Visceral obesity and a high serum leptin level may be risk factors for colorectal adenomatous polyp development in Japanese men.

Robotic Insertion of Various Ablation Needles Under Computed Tomography Guidance: Accuracy in Animal Experiments.

OBJECTIVE: To evaluate the accuracy of robotic insertion of various ablation needles at various locations under computed tomography (CT) guidance in swine. MATERIALS AND METHODS: The robot was used for CT-guided insertion of four ablation needles, namely a single internally cooled radiofrequency ablation (RFA) needle (Cool-tip), a multi-tined expandable RFA needle (LeVeen), a cryoablation needle (IceRod), and an internally cooled microwave ablation needle (Emprint). One author remotely operated the robot with the operation interface in order to orient and insert the needles under CT guidance. Five insertions of each type of ablation needle towards 1.0-mm targets in the liver, kidney, lung, and hip muscle were attempted on the plane of an axial CT image in six swine. Accuracy of needle insertion was evaluated as the three-dimensional length between the target centre and needle tip. The accuracy of needle insertion was compared according to the type of needle used and the location using one-way analysis of variance. RESULTS: The overall mean accuracy of all four needles in all four locations was 2.8 mm. The mean accuracy of insertion of the Cool-tip needle, LeVeen needle, IceRod needle, and Emprint needle was 2.8 mm, 3.1 mm, 2.5 mm, and 2.7 mm, respectively. The mean accuracy of insertion into the liver, kidney, lung, and hip muscle was 2.7 mm, 2.9 mm, 2.9 mm, and 2.5 mm, respectively. There was no significant difference in insertion accuracy among the needles (P = .38) or the locations (P = .53). CONCLUSION: Robotic insertion of various ablation needles under CT guidance was accurate regardless of type of needle or location in swine.

Visual Evoked Potential Recovery by Subretinal Implantation of Photoelectric Dye-Coupled Thin Film Retinal Prosthesis in Monkey Eyes With Macular Degeneration.

Retinal prosthesis or artificial retina is a promising modality of treatment for outer retinal degeneration, caused by primary and secondary loss of photoreceptor cells, in hereditary retinal dystrophy and age-related macular degeneration, respectively. Okayama University-type retinal prosthesis (OUReP) is a photoelectric dye-coupled polyethylene film which generates electric potential in response to light and stimulates nearby neurons. The dye-coupled films were implanted by vitreous surgery in the subretinal space of monkey eyes with macular degeneration which had been induced by cobalt chloride injection from the scleral side. A pilot 1-month observation study involved 6 monkeys and a pivotal 6-month observation study involved 8 monkeys. Of 8 monkeys in 6-month group, 3 monkeys underwent dye-coupled film removal at 5 months and were observed further for 1 month. The amplitude of visual evoked potential which had been reduced by macular degeneration did recover at 1 month after film implantation and maintained the level at 6 months. Optical coherence tomography showed no retinal detachment, and full-field electroretinograms maintained a-wave and b-wave amplitudes, indicative of no retinal toxicity. Pathological examinations after 6-month implantation showed structural integrity of the inner retinal layer in close apposition to dye-coupled films. The implanted films which were removed by vitrectomy 5 months later showed light-evoked surface electric potentials by scanning Kelvin probe measurement. The photoelectric dye-coupled film (OUReP), which serves as a light-receiver and a displacement current generator in the subretinal space of the eye, has a potential for recovering vision in diseases with photoreceptor cell loss, such as retinitis pigmentosa and age-related macular degeneration.

In situ tissue regeneration using a warp-knitted fabric in the canine aorta and inferior vena cava.

OBJECTIVES: Materials used in paediatric cardiac surgery have drawbacks of deterioration, calcification and pseudointimal proliferation resulting in haemodynamic disturbance. The aim of this study was to investigate whether these drawbacks can be overcome by in situ tissue regeneration using a newly developed synthetic hybrid fabric (SHF). METHODS: The SHF is an expandable, warp-knitted fabric composed of a combination of biodegradable [poly-l-lactic acid (PLLA)] and non-biodegradable (polyethylene terephthalate) yarns. The fabric is coated with cross-linked gelatin. Mechanical properties of the SHF were compared with those of 2 commercial products: expanded polytetrafluoroethylene sheet and glutaraldehyde-treated bovine pericardium. An oval-shaped defect created in the canine descending aorta or inferior vena cava was filled with the SHF patch. After 2 weeks and 1, 3, 6 and 12 (or 24 in the inferior vena cava) months, the patch was removed for histological examination and evaluation of the remaining PLLA. RESULTS: The SHF exhibited satisfactory tensile and suture retention strength for surgical implantation similar to or better than the 2 commercial products. Tissue regeneration was induced with multilayered smooth muscle cells and collagen fibres on both sides of the patch, along with a mature endothelial layer and tissue connections containing vasa vasorum across the patch in the aorta and inferior vena cava. Inflammatory reactions were minimal, and no calcium deposition occurred. The molecular weight of PLLA was reduced to half at 12 months after implantation. CONCLUSIONS: The SHF may solve the drawbacks of the existing products. Further studies of the expandability of the SHF patch after degradation of PLLA are warranted.