Effect of endoscopic surgical skill qualification system for laparoscopic multivisceral resection: Japanese multicenter analysis.

BACKGROUND: The efficacy of laparoscopic multivisceral resection (Lap-MVR) has been reported by several experienced high-volume centers. The Endoscopic Surgical Skill Qualification System (ESSQS) was established in Japan to improve the skill of laparoscopic surgeons and further develop surgical teams. We examined the safety and feasibility of Lap-MVR in general hospitals, and evaluated the effects of the Japanese ESSQS for this approach. METHODS: We retrospectively reviewed 131 patients who underwent MVR between April 2016 and December 2019. Patients were divided into the laparoscopic surgery group (LAC group, n = 98) and the open surgery group (OPEN group, n = 33). The clinicopathological and surgical features were compared between the groups. RESULTS: Compared with the OPEN group, BMI was significantly higher (21.9 vs 19.3 kg/m2, p = 0.012) and blood loss was lower (55 vs 380 ml, p < 0.001) in the LAC group. Operation time, postoperative complications, and postoperative hospital stay were similar between the groups. ESSQS-qualified surgeons tended to select the laparoscopic approach for MVR (p < 0.001). In the LAC group, ESSQS-qualified surgeons had superior results to those without ESSQS qualifications in terms of blood loss (63 vs 137 ml, p = 0.042) and higher R0 resection rate (0% vs 2.0%, p = 0.040), despite having more cases of locally advanced tumor. In addition, there were no conversions to open surgery among ESSQS-qualified surgeons, and three conversions among surgeons without ESSQS qualifications (0% vs 15.0%, p = 0.007). Multivariate analysis revealed blood loss (odds ratio 1.821; 95% CI 1.324-7.654; p = 0.010) as an independent predictor of postoperative complications. Laparoscopic approach was not a predictive factor. CONCLUSIONS: The present multicenter study confirmed the feasibility and safety of Lap-MVR even in general hospitals, and revealed superior results for ESSQS-qualified surgeons.

Latent Structure Analysis of Wet-Granulation Tableting Process Based on Structural Equation Modeling.

Quality by design (QbD) is an essential concept for modern manufacturing processes of pharmaceutical products. Understanding the science behind manufacturing processes is crucial; however, the complexity of the manufacturing processes makes implementing QbD challenging. In this study, structural equation modeling (SEM) was applied to understand the causal relationships between variables such as process parameters, material attributes, and quality attributes. Based on SEM analysis, we identified a model composed of the above-mentioned variables and their latent factors without including observational data. Difficulties in fitting the observed data to the proposed model are often encountered in SEM analysis. To address this issue, we adopted Bayesian estimation with Markov chain Monte Carlo simulation. The tableting process involving the wet-granulation process for acetaminophen was employed as a model case for the manufacturing process. The results indicate that SEM analysis could be useful for implementing QbD for the manufacturing processes of pharmaceutical products.

Design and Optimization of Scored Tablets with Concave Surface and Application of Bayesian Estimation for Solving Scaleup Problem.

From the viewpoint of self-medication, it is valuable to develop patient-friendly scored tablets that possess dividing uniformity. In this context, we attempted to optimize the preparation conditions for a tablet with a unique shape, such as a concavely curved scored tablet (CCST). Employing a design of experiment and a response surface method incorporating a thin-plate spline interpolation, and a bootstrap resampling technique, the optimal preparation conditions for CCST were successfully developed. To make it possible to scaleup the optimal solution estimated on a trial-scale, a Bayesian estimation was applied. Credible ranges of critical responses in large-scale manufacturing were estimated as a posterior probability from the trial-scale experiment as a prior probability. In terms of the large-scale manufacturing, the possibility of solving the scaleup problem was suggested using Bayesian estimation. Furthermore, a simulation study using a finite element method revealed that strong tensile stresses generated along the tip of the score line in CCST when an outer force was applied to the back surface of CCST. An advantage in dividing uniformity is indicated by the unique shape of CCST.

Impact of rotational errors of whole pelvis on the dose of prostate-based image-guided radiotherapy to pelvic lymph nodes and small bowel in high-risk prostate cancer.

BACKGROUND: The target volume increases when the prostate and pelvic lymph nodes (PLNs) are combined, and the fiducial markers (FMs) are placed at the edge of the irradiation field. Thus, the position of FMs may be changed by the rotational errors (REs) of "whole pelvis". The aim of this study was to examine the impact of REs of "whole pelvis" on the dose of FMs-based image-guided radiotherapy to the PLNs and the small bowel in prostate cancer including the PLNs. MATERIALS AND METHODS: We retrospectively evaluated 10 patients who underwent prostate cancer radiotherapy involving the PLNs. The position of FMs was calculated from the radiographs obtained before and after the 6D correction of pelvic REs. We simulated the delivery dose considering the daily pelvic REs and calculated the difference from the planned dose in the D98% of the PLN clinical target volume and the D2cc, and V45Gy of the small bowel. RESULT: The position of FMs strongly correlated with the pelvic REs in the pitch direction (r = 0.7788). However, the mean delivered doses to PLNs for 10 patients were not significantly different from the planned doses (p = 0.625). Although the D2cc and V45Gy of the small bowel strongly correlated with the pitch rotation of the pelvis, there was no significant difference between the delivered and planned doses (p = 0.922 and p = 0.232, respectively). CONCLUSION: The dosimetric effect of pelvic REs on the dose to PLNs and the small bowel was negligible during the treatment course.

Impact of Pelvic Rotational Setup Error on Lymph Nodal Dose in Whole Pelvic IMRT Using Fiducial Markers.

PURPOSE: The aim of this study was to investigate the impact of pelvic rotational setup error on lymph nodal dose in the whole pelvic intensity-modulated radiation therapy using the fiducial marker. METHODS: The dose differences of clinical target volume for pelvic lymph node (CTVLN) due to isocenter (IC) shift and pelvic rotation were evaluated using the radiation treatment planning system. The rotated computed tomography (CT) images were created for the simulation of the pelvic rotation. The original CT images were rotated around the IC of the original plan in the pitch and roll directions up to±3.0 deg. at 1.0 deg. intervals. As simulated plans, IC positions were shifted in the anterior-posterior and superior-inferior directions up to±10 mm at 2 mm intervals in the original and rotated CT images, and the dose distributions were calculated. The dose calculation was performed for each CT image while keeping the movement of multi leaf collimator and the monitor unit of the original plan. The differences between D98% of CTVLN in the original plan and simulated plans were calculated. RESULTS: In the posterior direction shifts of 4, 6, 8, and 10 mm, the dose reduction of 0.7, 2.1, 6.1, and 11.9% from the original plan were found for D98% of CTVLN, respectively. The dose reductions due to the rotation of pitch direction were greater than the rotation of roll direction. In the posterior direction shifts of 4, 6, 8, and 10 mm with 3.0 deg. rotation of pitch direction, the dose reduction of 2.2, 6.8, 12.8, and 19.0% from the original plan were found, respectively. CONCLUSION: The dose reduction of CTVLN might be occurred due to the rotational setup error of pitch direction.

Screw Motion Used in Semiconstrained Rotational Plate Systems for Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Retrospective observational study. OBJECTIVE: To scrutinize screw motion used in semiconstrained rotational plate systems for anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Semiconstrained rotational plate systems are supposed to control graft subsidence and facilitate lordosis acquisition and maintenance by toggling the instrumented vertebrae via variable-angle screws. However, their benefits may be unrealized if the screws move within the vertebrae. METHODS: We reviewed medical records of 119 patients who underwent 1-level, 2-level, 3-level, or 4-level ACDF, divided them into the short-segment (n=62, 1-level or 2-level ACDF) and long-segment (n=59, 3- level or 4-level ACDF) groups, and investigated their immediate and 1-year postoperative lateral radiographs. We measured the fused segmental angle, screw angles at the upper-instrumented vertebra (UIV) and lower-instrumented vertebra (LIV), distance from the screw base to the endplate of UIV/LIV (SBE), and distance from the screw tip to the endplate of UIV/LIV (STE) to analyze the screw motion used in these plate systems. The differences between the immediate and 1-year postoperative values were statistically analyzed. The nonunion level was also investigated. RESULTS: Screw angle and SBE at the LIV significantly decreased in the long-segment group (-14.5±9.8 degrees and -2.8±1.8 mm, respectively) compared with those in the short-segment group (-4.6±6.0 degrees and -1.0±1.5 mm, respectively). Thus, the long-segment group could not maintain the immediate-postoperative segmental angle. Overall, 27 patients developed nonunion, with 19 (70.4%) in the long-segment group and 21 (77.8%) at the lowest fused level. CONCLUSIONS: Semiconstrained rotational plate systems provide only vertical forces to the fused segment rather than toggling the instrumented vertebrae. Postoperatively in multilevel ACDF, LIV screws migrate caudally, suggesting that these plate systems are not always effective in maintaining lordosis. Moreover, LIV screws and the anterior wall of the LIV are subject to overloading, resulting in a high rate of nonunion at the lowest fused level. LEVEL OF EVIDENCE: Level III.

Tackling social anxiety with targeted brain stimulation: investigating the effects of transcranial static magnetic field stimulation on self-focused attention.

Previous studies suggested that self-focused attention (SFA), implicated in social anxiety disorder (SAD), correlates with heightened activity in the right frontopolar area (rFPA), which is the right prefrontal cortex just behind the forehead. Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation method capable of temporarily suppressing brain function beneath the magnet. We explored whether tSMS on individuals with tendencies toward SAD elicited (1) suppressing rFPA activation during the resting-state and (2) reducing SFA during a subsequent speech task. Twenty-three university students with social anxiety performed two speech tasks. Between tasks, the tSMS group received neodymium magnet stimulation while the sham group received fake magnet stimulation on the rFPA for 20 min. Resting-state rFPA activities was measured using functional near-infrared spectroscopy (fNIRS), while SFA (body sensations and observer perspective), field perspective, and detached mindfulness (DM) perspective were assessed via questionnaires during both speech tasks. The observer perspective means SFA to self-imagery from others' viewpoint, while the field and DM perspectives mean appropriately focusing on the external environment. The results indicated that tSMS intervention decreased rFPA activity from pre- to post-intervention rest. Then, tSMS reduced SFA to bodily sensations and increased DM perspective from pre- to post-intervention speech, especially in those with high levels of social anxiety. Furthermore, tSMS enhanced the field perspective regardless of social anxiety tendency. The results suggest that tSMS may suppress overactivity in rFPA, reduce SFA to body sensation, and increase adaptive attention in highly socially anxious individuals. Our study suggests the possibility of the clinical application of tSMS for treating SAD.

Ultrasound-Guided Lumbar Intradiscal Injection: A Case Report With a High-Resolution Ultrasound Image.

We present a case report demonstrating a new technique for intradiscal injection under ultrasound guidance in treating lumbar disc herniation. A 16-year-old female gymnast underwent this procedure and experienced relief from pain. Traditional methods have been noted for their technical challenges and potential risk of nerve root damage. In this case, our approach visualized the lateral side of the disc and improved needle visibility. This technique potentially offers a clearer high-resolution confirmation of the needle's position within the disc. It is considered that this technique is effective not only for performing precise injections but also for enhancing safety due to the clear depiction of the needle tip entering the intervertebral disc.

Maculopapular Drug Eruption Caused by Apalutamide: Case Report and Review of the Literature.

Apalutamide, an oral androgen receptor signaling inhibitor, is approved for the treatment of non-metastatic castration-resistant prostate cancer and metastatic prostate cancer. In the international randomized placebo-controlled clinical trials, apalutamide was associated with a higher rate of rash than placebo. However, given that reports from a dermatological perspective are limited, the skin manifestations and histopathology of the skin lesions caused by apalutamide are largely unknown. Here, we report a case of apalutamide-induced drug eruption. A 66-year-old man developed itchy maculopapular erythema on the trunk and extremities 10 weeks after starting apalutamide for progressive prostate cancer. A biopsy specimen showed interface dermatitis with perivascular lymphocytic infiltration in the upper dermis. The lymphocyte transformation test was positive for apalutamide. The skin manifestations improved after discontinuation of apalutamide and treatment with topical corticosteroids and systemic prednisolone. A review of the dermatology literature on apalutamide-induced drug eruption yielded only six cases, including our case. Dermatologically, there were four cases of maculopapular rash and two of toxic epidermal necrolysis and histopathologically, there were three cases of interface dermatitis, two of epidermal necrosis, and one of spongiotic dermatitis. Four patients had peripheral eosinophilia. A lymphocyte transformation test was performed in three cases and was positive for apalutamide in all cases. Except for the two cases of toxic epidermal necrolysis, which were fatal, the skin eruptions appeared 10 weeks after starting apalutamide. Considering the increasing number of patients with prostate cancer being treated with apalutamide, cases of apalutamide-induced drug eruption need to be accumulated and analyzed.

Optimum Vertebral Level of Castellvi Type III or Higher Lumbosacral Transitional Vertebrae When Measuring Spinopelvic Parameters.

BACKGROUND: Castellvi type III and IV lumbosacral transitional vertebrae (LSTVs) are fused to the sacrum. In these cases, the pelvic incidence (PI) and pelvic tilt (PT) may vary according to the selected "S1." This study aimed to determine the optimum vertebral level of these LSTVs when measuring PI and PT. METHODS: PI and PT were measured twice in 56 patients with type III and IV LSTVs with a balanced spine, with LSTV considered as the lowest lumbar vertebra (LLV) or S1. PI and PT measured with LSTV as LLV were denoted as LLV_PI and LLV_PT, and those measured as S1 were denoted as S_PI and S_PT. Reference ranges (mean -2 SD to +2 SD) of PI and PT were derived from 183 non-LSTV patients with a balanced spine as 35.5° to 68.8° (PI) and 2.5° to 29.6° (PT). If S_PI, S_PT, or both were below the reference range, the LSTV was interpreted as LLV. If LLV_PI, LLV_PT, or both were above the reference range, it was interpreted as S1. If all parameters were within the respective reference range, it was interpreted as an intermediate type. RESULTS: The optimum vertebral level of LSTV was S1 (n = 29, 51.8%), most frequently due to high LLV_PT (35.4°±4.7), followed by LLV (n = 14, 25%) due to low S_PI (31.5°±5.2) and intermediate type (n = 13, 23.2%). CONCLUSIONS: If PI is too small or PT is too large to represent the actual sagittal alignment in patients with Castellvi type III and IV LSTVs, the selected S1 should be reconsidered. CLINICAL RELEVANCE: PI and PT measurements can be used to determine whether the optimum vertebral level of Castellvi type III and IV LSTV should be considered LLV or S1.

Evaluating the effect of high-density measurement mode on patient-specific quality assurance for head and neck cancer with ArcCHECK.

The high-density measurement (HDm) mode of the ArcCHECK device can achieve a twofold resolution enhancement compared to the standard measurement (Sm) mode. The aim of this study was to evaluate the effect of HDm on the gamma passing rate (GPR) for the patient-specific quality assurance (PSQA) in head and neck cancer. We retrospectively evaluated 30 patients who underwent volumetric modulated arc therapy (VMAT) for head and neck cancer. Absolute gamma analysis was performed on Sm and HDm data. We also investigated correlations between the modulation complexity score for VMAT (MCSv) and differences in the GPR between the two measurement modes. The global GPR of Sm and HDm was 81.0% ± 8.4% and 82.6% ± 7.6% for the 2%/2 mm criterion, 94.0% ± 4.1% and 94.9% ± 3.6% for the 3%/2 mm criterion, and 96.6% ± 2.4% and 97.0% ± 2.4% for the 3%/3 mm criterion, respectively. HDm slightly improved GPR (p < 0.01) for the 2%/2 mm criterion. Differences in GPR between Sm and HDm for the 2%/2 mm, 3%/2 mm, and 3%/3 mm criteria were 1.6% ± 3.0%, 0.8% ± 2.0%, and 0.4% ± 1.2%, respectively. No correlation was identified between the MCSv and the difference in GPR between Sm and HDm. Despite an improvement in GPR with HDm, the difference in GPR between Sm and HDm was approximately 2% even when the tighter criteria were used. Moreover, the change in the GPR between Sm and HDm did not depend on plan complexity. Thus, the effect of HDm on GPR is limited for the PSQA in VMAT for head and neck cancer.

Effect of Neoadjuvant Chemotherapy in Patients With Locally Advanced Rectal Cancer: A Multicenter Propensity Score-matched Analysis.

BACKGROUND/AIM: The effect of neoadjuvant chemotherapy (NAC) and adjuvant chemotherapy (AC) for locally advanced rectal cancer (LARC) is not fully understood. This study aimed to identify outcomes following NAC plus AC for LARC. PATIENTS AND METHODS: We reviewed 252 patients who underwent curative resection for LARC. Propensity score matching matched 51 patients in NAC and non-NAC groups. RESULTS: Operative time (443 min vs. 286 min, p<0.001), blood loss (279 ml vs. 124 ml p<0.001), and number of patients who received AC were higher in the NAC group (74.5% vs. 33.3%, p<0.001). The Disease control rate of NAC group was 98.1%. The NAC group showed better 3-year RFS (86.5% vs. 62.1%, p=0.021). Patients who received both NAC and AC displayed better 3-year RFS (90.2%) compared to the non-NAC group both with (63.8%) and without (60.4%) AC (p<0.05). CONCLUSION: NAC and AC for LARC have the potential to improve oncological outcomes.

Efficacy of a Nonrigid Image-registration Method in Comparison to Readout-segmented Echo-planar Imaging for Correcting Distortion in Diffusion-weighted Imaging.

We evaluated the effectiveness of distortion correction using a nonrigid image registration method in diffusion-weighted imaging, comparing it with readout-segmented echo planar imaging (RS-EPI). Unlike the RS-EPI, the effectiveness of the distortion correction of the nonrigid registration method depended on the slice level, being most accurate at the level of the basal ganglia, lateral ventricle, and centrum semiovale.

A case of two traumatic penetrations of a duodenal diverticulum caused by a kick to the upper abdomen.

INTRODUCTION AND IMPORTANCE: A duodenal diverticulum is a pseudodiverticulum that lacks a proper muscular layer. Cases of traumatic penetration or perforation of a duodenal diverticulum are relatively rare. CASE PRESENTATION: A 67-year-old woman was injured when her roommate kicked her in the upper abdomen, and was transferred to our hospital 6 h after the injury with upper abdominal pain and lethargy. Computed tomography revealed a duodenal diverticulum and retroperitoneal emphysematous changes and exudates. Peritonitis due to duodenal penetration was suspected and emergency laparotomy was performed. Intraoperative findings revealed two traumatic penetrations of the duodenal diverticulum. We resected the diverticulum with an automatic suture device and covered the resection site with omentum. Twenty-one days postoperatively, she was transferred to her original hospital with no complications following an uneventful postoperative course. CLINICAL DISCUSSION: Most causes of penetration or perforation of the duodenal diverticulum are diverticulitis, and few reports have described penetration or perforation of duodenal diverticulum due to trauma. Our case was extremely rare that caused by a kick to the upper abdomen and resulted in two penetrations of a duodenal diverticulum although factors contributing to the multiple penetrations were considered. CONCLUSION: Penetration or perforation of a duodenal diverticulum occasionally results in a rapid deterioration to a severe state. Comprehensive judgement of the general condition and laboratory findings and selection of an appropriate treatment policy is important.

Target coverage of daily cone-beam computed tomography in breath-hold image-guided radiotherapy for gastric lymphoma.

OBJECTIVES: We evaluated retrospectively the daily target coverage using cone-beam computed tomography (CBCT) in breath-hold image-guided radiotherapy (BH-IGRT) for gastric lymphoma. METHODS: BH-IGRT was performed using a prescribed dose of 30.6 Gy in 17 fractions for the whole stomach. We assessed the target coverage of the whole stomach on daily CBCT images [daily clinical target volume (CTV)], which was delineated individually by two observers. We evaluated V95% (percentage of volume receiving ≥95% of the prescribed dose) of daily CTV. RESULTS: In total, 102 fractions from 6 patients were assessed. The mean V95% of daily CTV was 97.2%, which was over 95%. In two of six patients, the V95% of daily CTV was over 95% for either observer in all fractions. One patient had significant interobserver variation (p = 0.013). In 95 fractions (93%), the V95% of daily CTV was over 95% for either observer. CONCLUSION: Daily target coverage for CTV in BH-IGRT for gastric lymphoma seems to be favorable, even when using CBCT. ADVANCES IN KNOWLEDGE: A previous study ascertained good daily target coverage in BH-IGRT for gastric lymphoma using in-room CT. Even when using CBCT in our study, daily target coverage for CTV in BH-IGRT for gastric lymphoma seems to be favorable.

Accuracy of target delineation by positron emission tomography-based auto-segmentation methods after deformable image registration: A phantom study.

PURPOSE: Diagnostic positron emission tomography and computed tomography (PET/CT) images can be fused to the planning CT images by a deformable image registration (DIR). The aim of this study was to evaluate the standardized uptake value (SUV) and target delineation on deformed PET images. METHODS: We used a cylindrical phantom and removable inserts of four spheres (16-38 mm in diameter) and three ellipsoids with a volume equal to the 38-mm-diameter sphere (S38) in each. S38 was filled with 18F-fluorodeoxyglucose activity, and then PET/CT images were acquired. The contours of S38 were generated using original PET images by PET auto-segmentation (PET-AS) methods of (1) SUV2.5, (2) 40% of maximum SUV (SUV40%max), and (3) gradient-based (GB), and were deformed to the other inserts by DIR. We compared the volumes and the SUVmax with the generated contours using the deformed PET images. RESULTS: The SUVmax was slightly decreased by DIR; the mean absolute difference was -0.10 ± 0.04. For SUV2.5 and SUV40%max, the differences in S38 volumes between the original and deformed PET images were less than 5%, regardless of deformation type. For the GB, the contoured volumes obtained from deformed PET images were larger than those of the original PET images for the deformation type of ellipsoids. When the S38 was deformed to the 16-mm-diameter sphere, the maximum volume difference was -22.8%. CONCLUSIONS: Although SUV fluctuations by DIR were negligible, the target delineation on deformed PET images by the GB should be carefully considered owing to the distortion of intensity profiles.

Expression and purification of peanut oleosins in insect cells.

Oleosins contain a unique hydrophobic domain which is inserted into the oil matrix and are involved in the formation and stability of plant oil bodies. These proteins have also been reported to possess some allergenic properties. Therefore, knowledge of its three-dimensional structure is vital for further structural and immunological characterization. However, due to the difficulty of soluble recombinant expression in Escherichia coli, no studies have been done in line with this goal. Here, we have developed a novel expression and purification system for three peanut oleosin isoforms (14 k, 16 k, and 18 kDa oleosins). Oleosin cDNAs were cloned and subsequently expressed in soluble form in insect cell-baculovirus system. Recombinant proteins can be purified to homogeneity using only Ni Sepharose affinity chromatography. Thermal denaturation midpoint temperatures of recombinant oleosins were also assayed and found to be very similar to that of native oleosins, indicating proper structural conformation of the recombinant proteins.