Ingestible light source for intragastric antibacterial phototherapy: a device safety study on a minipig model.

Helicobacter pylori gastric infections are among the most diffused worldwide, suffering from a rising rate of antibiotic resistance. In this context, some of the authors have previously designed an ingestible device in the form of a luminous capsule to perform antibacterial photodynamic inactivation in the stomach. In this study, the light-emitting capsules were tested to verify the safety of use prior to perform clinical efficacy studies. First, laboratory tests measured the capsule temperature while in function and verified its chemical resistance in conditions mimicking the gastric and gut environments. Second, safety tests in a healthy minipig model were designed and completed, to verify both the capsule integrity and the absence of side effects, associated with its illumination and transit throughout the gastrointestinal tract. To this aim, a capsule administration protocol was defined considering a total of 6 animals with n = 2 treated with 8 capsules, n = 2 treated with 16 capsules and n = 2 controls with no capsule administration. Endoscopies were performed in sedated conditions before-after every capsule administration. Biopsies were taken from the corpus and antrum regions, while the gastric cavity temperature was monitored during illumination. The bench tests confirmed a very good chemical resistance and a moderate (about 3 °C) heating of the capsules. The animal trials showed no significant effects on the gastric wall tissues, both visually and histologically, accompanied with overall good animal tolerance to the treatment. The integrity of the administered capsules was verified as well. These encouraging results pose the basis for the definition of successive trials at the clinical level.

Hemorrhoid laser dearterialization: systematic review and meta-analysis.

Hemorrhoidal disease is a common and troublesome condition. Excisional hemorrhoidectomy can assure the best chance of cure but it is hampered by postoperative pain and potential long-term morbidity therefore minimally invasive techniques have been developed. Since 2009 a doppler-guided hemorrhoidal dearterialization with laser (the hemorrhoidal laser procedure; HeLP) has been proposed to control symptoms without significant sequelae. The aim of this systematic review is to analyze the benefits and disadvantages of HeLP for symptomatic hemorrhoids. The Medline/PubMed, Embase, and Cochrane library databases were searched from January 2010 to March 2022, language was restricted to English and documents to the full text. Randomized and non-randomized, prospective and retrospective cohort studies were included. Risk of bias assessment was performed using the Risk of bias for non-randomized studies (ROBINS-I) and the RoB2 Tool for randomized clinical trial. Primary outcome was to assess the efficacy of HeLP on symptoms' resolution. Secondary objectives were postoperative pain and complications, comparison with other interventional techniques, and evaluation of long-term recurrence. Whenever possible, a meta-analysis was conducted. The GRADE approach was employed to assess the certainty of evidence. We included six non-randomized and one randomized study. HeLP improved or resolved preoperative symptoms in 83.6 to 100% of patients during follow-up. In the randomized study symptoms resolved in 90% of patients after HeLP and 53.3% after rubber band ligation as comparator. Published data indicate that HeLP is effective, relatively safe, with limited recurrence rate, after a short to medium follow-up. The quality of evidence was however low. There is a paucity of studies assessing the benefits or harms of laser dearterialization for the treatment of hemorrhoids and randomized trials are furthermore rare, therefore trials with adequate power and proper design, assessing the advantages and disadvantages of HeLP versus other minimally invasive techniques, are needed. Furthermore, studies evaluating long-term follow-up are wanted.

Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial.

BACKGROUND: Insufficient vascular supply is one of the main causes of anastomotic leak in colorectal surgery. Intraoperative indocyanine-green (ICG) angiography has been shown to provide information on tissue perfusion, identifying a well-perfused location for colonic and rectal transections, and thus possibly reducing the leak rate. Aim of this study was to evaluate the usefulness of intraoperative assessment of anastomotic perfusion using ICG angiography in patients undergoing left-sided colon or rectal resection with colorectal anastomosis. METHODS: This randomized trial involved 252 patients undergoing laparoscopic left-sided colon and rectal resection randomized 1:1 to intraoperative ICG or to subjective visual evaluation of the bowel perfusion without ICG. The primary aim was to assess whether ICG angiography could lead to a reduction in anastomotic leak rate. Secondary outcomes were possible changes in the surgical strategy and postoperative morbidity. RESULTS: After randomization, 12 patients were excluded. Accordingly, 240 patients were included in the analysis; 118 were in the study group, and 122 in the control group. ICG angiography showed insufficient perfusion of the colic stump, which led to extended bowel resection in 13 cases (11%). An anastomotic leak developed in 11 patients (9%) in the control group and in 6 patients (5%) in the study group (p = n.s.). CONCLUSIONS: Intraoperative ICG fluorescent angiography can effectively assess vascularization of the colic stump and anastomosis in patients undergoing colorectal resection. This method led to further proximal bowel resection in 13 cases, however, there was no statistically significant reduction of anastomotic leak rate in the ICG arm. CLINICAL TRIAL: ClinicalTrials.gov NCT02662946.

Renal Resistance Trend During Hypothermic Machine Perfusion Is More Predictive of Postoperative Outcome Than Biopsy Score: Preliminary Experience in 35 Consecutive Kidney Transplantations.

Hypothermic machine perfusion (HPM) grants a better postoperative outcome in transplantation of organs procured from extended criteria donors (ECDs) and donors after cardiac death (DCD). So far, the only available parameter for outcome prediction concerning those organs is pretransplant biopsy score. The aim of this study is to evaluate whether renal resistance (RR) trend during HPM may be used as a predictive marker for post-transplantation outcome. From December 2015 to present, HMP has been systematically applied to all organs from ECDs and DCD. All grafts underwent pretransplantation biopsy evaluation using Karpinski's histological score. Only organs that reached RR value ≤1.0 within 3 hours of perfusion were transplanted. Single kidney transplantation (SKT) or double kidney transplantation (DKT) were performed according to biopsy score results. Sixty-five HMPs were performed (58 from ECDs and 7 from DCD/ECMO donors). Fifteen kidneys were insufficiently reconditioned (RR > 1) and were therefore discarded. Forty-nine kidneys were transplanted, divided between 21 SKT and 14 DKT. Overall primary nonfunction (PNF) and delayed graft function (DGF) rate were 2.9 and 17.1%, respectively. DGF were more common in kidneys from DCD (67 vs. 7%; P = 0.004). Biopsy score did not correlate with PNF/DGF rate (P = 0.870) and postoperative creatinine trend (P = 0.796). Recipients of kidneys that reached RR ≤ 1.0 within 1 hour of HMP had a lower PNF/DGF rate (11 vs. 44%; P = 0.033) and faster serum creatinine decrease (POD10 creatinine: 1.79 mg/dL vs. 4.33 mg/dL; P = 0.019). RR trend is more predictive of post-transplantation outcome than biopsy score. Hence, RR trend should be taken into account in the pretransplantation evaluation of the organs.

A feasibility dosimetric study on prostate cancer : are we ready for a multicenter clinical trial on SBRT?

PURPOSE: The Italian Association of Medical Physics (AIFM) started a working group dedicated to stereotactic body radiotherapy (SBRT) treatment. In this work, we performed a multicenter planning study on patients who were candidates for SBRT in the treatment of prostate cancer with the aim of evaluating the dosimetric consistency among the different hospitals. METHODS AND MATERIALS: Fourteen centers were provided the contours of 5 patients. Plans were performed following the dose prescription and constraints for organs at risk (OARs) of a reference paper. The dose prescription was 35 Gy in five fractions for the planning target volume (PTV). Different techniques were used (3D-CRT, fixed-Field IMRT, VMAT, CyberKnife). Plans were compared in terms of dose-volume histogram (DVH) parameters. Furthermore, the median DVH was calculated and one patient was re-planned. RESULTS: A total of 70 plans were compared. The maximum dose to the body was 107.9 ± 4.5 % (range 101.5-116.3 %). Dose at 98 % (D98 %) and mean dose to the clinical target volume (CTV) were 102.0 ± 0.9 % (global range 101.1-102.9 %) and 105.1 ± 0.6 % (range 98.6-124.6 %). Similar trends were found for D95 % and mean dose to the PTV. Important differences were found in terms of the homogeneity index. Doses to OARs were heterogeneous. The subgroups with the same treatment planning system showed differences comparable to the differences of the whole group. In the re-optimized plans, DVH differences among institutes were reduced and OAR sparing improved. CONCLUSION: Important dosimetric differences with possible clinical implications, in particular related to OARs, were found. Replanning allowed a reduction in the OAR dose and decreased standard deviations. Multicenter clinical trials on SBRT should require a preplanning study to standardize the optimization procedure.

Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma.

BACKGROUND: Long-term local control in Glioblastoma is rarely achieved and nearly all patients relapse. In this study we evaluated the clinical effect of different treatment approaches in recurrent patients. METHODS: Forty-three patients, with median age of 51 years were evaluated for salvage treatment: re-resection and/or re-irradiation plus chemotherapy or chemotherapy alone. Response was recorded using the Response Assessment in Neuro-Oncology criteria. Hematologic and non-hematologic toxicities were graded according to Common Terminology Criteria for Adverse Events 4.0. Twenty-one patients underwent chemotherapy combined with local treatment, surgery and/or radiation therapy, and 22 underwent chemotherapy only. RESULTS: The median follow up was 7 months (range 3-28 months). The 1 and 2-years Progression Free Survival was 65 and 10 % for combined treatment and 22 and 0 % for chemotherapy alone (p < 0.01). The 1 and 2-years overall survival was 69 and 29 % for combined and 26 and 0 % for chemotherapy alone (p < 0.01). No toxicity greater than grade 2 was recorded. CONCLUSION: These data showed that in glioblastoma recurrence the combination of several approaches in a limited group of patients is more effective than a single treatment alone. This stress the importance of multimodality treatment whenever clinically feasible.

Dumon silicone stents can improve respiratory function in dogs with grade IV tracheal collapse: 12 cases (2019-2023).

OBJECTIVE: To evaluate the efficacy, complications, and outcome of Dumon silicone stent placement for dogs with grade IV tracheal collapse. ANIMALS: 12 client-owned dogs. CLINICAL PRESENTATION: Each dog was diagnosed with grade IV TC unresponsive to medical therapy and had severe obstructive respiratory failure. RESULTS: 12 dogs were included in the study. By the end of the study, 5 of 12 (41.7%) remained alive, while 7 of 12 (58.3%) dogs died. Survival times after stent placement ranged from 97 to 1,310 days (mean, 822.43 days; median, 810 days). Three of the 12 (25%) dogs died spontaneously, while 4 of 12 (33.3%) were euthanized. The cause of death was determined for 6 of 7 (85.7%) dogs and was TC related for 3 of 7 (50%). Causes of death related to TC were progressive airway collapse (2/3 [66.6%]) and incoercible cough (1/3 [33.4%]). Complications occurred in 9 of 12 (75%) cases and included granulation tissue growth (3/12 [25%]), incoercible cough (2/12 [16.7%]), stent migration (1/12 [8.3%]), and stent deformation (1/12 [8.3%]). Reduction of obstructive dyspnea and episodes of asphyxiation was achieved after Dumon silicone stent placement. CLINICAL RELEVANCE: The placement of an intraluminal Dumon silicone stent was a successful salvage treatment for TC in dogs that did not respond to medical management. Disease progression is inevitable, but substantial improvement of respiratory function may be achieved for months to years.

Prognostic indicators for canine parvoviral enteritis in a Teaching Hospital in Italy: a retrospective study of 76 cases.

Potential prognostic indicators have been associated with decreased survival during canine parvoviral enteritis (CPE), such as body weight, sex, and clinicopathological parameters. Few studies reported the prognostic factors for CPE in Italy; therefore, the aim of this study was to identify prognostic factors associated with the survival of dogs admitted to the Veterinary Teaching Hospital of Perugia University, naturally infected with canine parvovirus. Seventy-six medical records of dogs with a definitive diagnosis of parvoviral infection admitted from 2017 to 2021 have been reviewed and included in the study. From medical records were extracted data on signalment, history, clinical examination, hematology, serum biochemistry, treatments, progression of clinical signs during hospitalization and outcome. The data have been subjected to univariate and multivariate statistical analysis. Our results showed winter season, male sex, dog ownership, small breed, normal sensory status, normal heart rate, normal hydration status, abdominal pain, increased capillary reperfusion time, and normal white blood cell count as positive prognostic factors. The survival model confirmed that parameters such as male sex, small breed, and ownership increased the survival rate during hospitalization. Data reported in the present study are partially in agreement with previous studies and added new information on the possible prognostic factors in dogs affected by CPE in Italy.

Monocytes Count, NLR, MLR and PLR in Canine Inflammatory Bowel Disease.

This is an observational retrospective study on 85 client-owned dogs, 60 with IBD and 25 clinically healthy dogs. This study aims to assess the clinical relevance of some easy to obtain and cost-effective hematological parameters including red blood cell distribution width (RDW), neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), and platelet-to-lymphocyte ratio (PLR) in dogs with IBD. Comparison of clinical and laboratory parameters between dogs with IBD and control dogs was carried out and the ability to distinguish between these two groups of dogs was evaluated by calculating the area under the receiver-operating characteristic curve (AUCROC). Univariate and multivariable logistic regression analysis estimated the odds ratio (OR) of developing IBD with a 95% confidence interval (CI). MLR and monocytes count had the highest accuracy in facilitating the discrimination of dogs with IBD from control dogs with an AUCROC of 0.839 and 0.787 at the cut-off of >0.14% and >3.7 cells*102/µL, respectively. According to two multivariable models, monocytes count (OR = 1.29; p = 0.016), NLR (OR = 1.80; p = 0.016), and MLR > 0.14 (OR = 8.07; p < 0.001) and PLR > 131.6 (OR = 4.35; p = 0.024) were significant and independent predictors of IBD for models one and two, respectively. Monocytes count and the hematological ratios MLR, NLR, and PLR can be useful in the diagnostic work-up of dogs with IBD.

Serum D-Lactate Concentrations in Dogs with Inflammatory Bowel Disease.

The D-enantiomer of lactic acid (D-lactate) is normally produced from bacterial fermentation in the gastrointestinal tract in mammals. In humans, increased D-lactate concentrations are related to gastrointestinal disease, including short bowel syndrome and malabsorptive syndrome. Similarly, increased D-lactate concentrations have been described in calves affected by diarrhea, in cats with gastrointestinal diseases, and in dogs with parvoviral enteritis. The purpose of the present study was to measure the serum D-lactate concentrations in dogs with inflammatory bowel disease (IBD). We retrospectively reviewed data from the database of the VTH of Perugia University, and dogs affected by IBD with serum samples stored at -80 °C were considered eligible for inclusion. A total of 18 dogs with IBD and 10 healthy dogs were included in the study. The dogs with IBD were divided into three subcategories based on the severity of the disease. Serum D-lactate concentrations (µM) were determined using a commercially available colorimetric assay kit (D-Lactate Colorimetric Assay Kit; Catalog #K667-100, BioVision Inc., Milpitas, CA, USA). Our results showed no significant difference (p > 0.05) in the serum concentrations of D-lactate between dogs with various degrees of IBD and healthy dogs. However, the wide variability of the D-lactate concentrations in dogs with IBD and evidence of increased serum D-lactate concentrations in dogs with confirmed dysbiosis encourage further studies on this topic to understand potential factors influencing the serum D-lactate concentrations in dogs affected by IBD.