Robotic Versus Open Pancreatoduodenectomy With Vein Resection and Reconstruction: A Propensity Score-Matched Analysis.

Objective: This study aimed to compare robotic pancreatoduodenectomy with vein resection (PD-VR) based on the incidence of severe postoperative complications (SPC). Background: Robotic pancreatoduodenectomy has been gaining momentum in recent years. Vein resection is frequently required in this operation, but no study has compared robotic and open PD-VR using a matched analysis. Methods: This was an intention-to-treat study designed to demonstrate the noninferiority of robotic to open PD-VR (2011-2021) based on SPC. To achieve a power of 80% (noninferiority margin:10%; α error: 0.05; ß error: 0.20), a 1:1 propensity score-matched analysis required 35 pairs. Results: Of the 151 patients with PD-VR (open = 115, robotic = 36), 35 procedures per group were compared. Elective conversion to open surgery was required in 1 patient with robotic PD-VR (2.9%). One patient in both groups experienced partial vein thrombosis. SPC occurred in 7 (20.0%) and 6 patients (17.1%) in the robotic and open PD-VR groups, respectively (P = 0.759; OR: 1.21 [0.36-4.04]). Three patients died after robotic PD-VR (8.6%) and none died after open PD-VR (P = 0.239). Robotic PD-VR was associated with longer operative time (611.1 ± 13.9 minutes vs 529.0 ± 13.0 minutes; P < 0.0001), more type 2 vein resection (28.6% vs 5.7%; P = 0.0234) and less type 3 vein resection (31.4% vs 71.4%; P = 0.0008), longer vein occlusion time (30 [25.3-78.3] minutes vs 15 [8-19.5] minutes; P = 0.0098), less blood loss (450 [200-750] mL vs 733 [500-1070.3] mL; P = 0.0075), and fewer blood transfusions (intraoperative: 14.3% vs 48.6%; P = 0.0041) (perioperative: 14.3% vs 60.0%; P = 0.0001). Conclusions: In this study, robotic PD-VR was noninferior to open PD-VR for SPC. Robotic and open PD-VR need to be compared in randomized controlled trials.

Toward Environmentally sustainable surgery: Waste recycling in general surgery operating room. Preliminary cognitive audit.

BACKGROUND: It is common practice to classify waste from the operating theater as "clinical". The development of sustainable policies could have a significant impact. In the first phase, our study aims to measure general surgery waste and to assess the potential financial and carbon savings of appropriate recycling. Based on this information, we will plan for a second phase in which educational interventions will be put in place to promote waste segregation in surgical environments. METHODS: We conducted a preliminary cognitive audit of the most common general surgery procedures to examine the types and quantity of waste produced. We calculated the economic and environmental impacts of disposing of waste treated as clinical or general, and we measured how much of it could actually be recycled. Then, we attempted a projection of the savings we could expect if recycling policies were implemented. RESULTS: We found that more than 30% of total waste was actually recyclable. Considering a projection based on annual procedures performed in our hospital, we estimated that for each kind of surgical procedure, we could expect a reduction of the carbon footprint by approximately 6%, and an average 3% reduction in costs every year, only by improving waste segregation in the general surgery operating rooms. CONCLUSION: There could be a great potential for reducing environmental and economic footprint of the operating rooms by promoting waste recycling protocols. Surgeons are in a unique position to implement for these protocols. Interventions should be codesigned with theater staff to create a "green culture".

European Consensus on the Management of Sensitized Kidney Transplant Recipients: A Delphi Study.

An increasing number of sensitized patients awaiting transplantation face limited options, leading to fatalities during dialysis and higher costs. The absence of established evidence highlights the need for collaborative consensus. Donor-specific antibodies (DSA)-triggered antibody-mediated rejection (AMR) significantly contributes to kidney graft failure, especially in sensitized patients. The European Society for Organ Transplantation (ESOT) launched the ENGAGE initiative, categorizing sensitized candidates by AMR risk to improve patient care. A systematic review assessed induction and maintenance regimens as well as antibody removal strategies, with statements subjected to the Delphi methodology. A Likert-scale survey was distributed to 53 European experts (Nephrologists, Transplant surgeons and Immunologists) with experience in kidney transplant recipient care. A rate ≥75% with the same answer was considered consensus. Consensus was achieved in 95.3% of statements. While most recommendations aligned, two statements related to complement inhibitors for AMR prophylaxis lacked consensus. The ENGAGE consensus presents contemporary recommendations for desensitization and immunomodulation strategies, grounded in predefined risk categories. The adoption of tailored, patient-specific measures is anticipated to streamline the care of sensitized recipients undergoing renal allografts. While this approach holds the promise of enhancing transplant accessibility and fostering long-term success in transplantation outcomes, its efficacy will need to be assessed through dedicated studies.

Banff 2022 pancreas transplantation multidisciplinary report: Refinement of guidelines for T cell-mediated rejection, antibody-mediated rejection and islet pathology. Assessment of duodenal cuff biopsies and noninvasive diagnostic methods.

The Banff pancreas working schema for diagnosis and grading of rejection is widely used for treatment guidance and risk stratification in centers that perform pancreas allograft biopsies. Since the last update, various studies have provided additional insight regarding the application of the schema and enhanced our understanding of additional clinicopathologic entities. This update aims to clarify terminology and lesion description for T cell-mediated and antibody-mediated allograft rejections, in both active and chronic forms. In addition, morphologic and immunohistochemical tools are described to help distinguish rejection from nonrejection pathologies. For the first time, a clinicopathologic approach to islet pathology in the early and late posttransplant periods is discussed. This update also includes a discussion and recommendations on the utilization of endoscopic duodenal donor cuff biopsies as surrogates for pancreas biopsies in various clinical settings. Finally, an analysis and recommendations on the use of donor-derived cell-free DNA for monitoring pancreas graft recipients are provided. This multidisciplinary effort assesses the current role of pancreas allograft biopsies and offers practical guidelines that can be helpful to pancreas transplant practitioners as well as experienced pathologists and pathologists in training.

Safety and safety protocols for living donor nephrectomy in Italy.

Living donor kidney transplantation (LDKTx) is recommended by all scientific societies. Living donor nephrectomy (LDN) is probably one of the safest surgical procedures, but it carries some risk for healthy donors. The aim of this study is to provide a snapshot of LDKTx activities in Italy and ask about safety measures implemented in LDN. Data on LDKTx were extracted from the national database. Safety measures were examined through a specific survey. Between 2001 and 2022 40,663 kidney transplants (31.4 per million population-pmp) were performed, including 4731 LDKTx (3.7 pmp). There was no postoperative death of the donor. After a median follow-up of 52.2 months [IQR:17.9-99.5], the 10-year donor survival rate was 93.38% (CI:97.52-98.94). There was evidence of renal disease in 65 donors (1.8%), including 42 (1.1%) with stage III end-stage renal disease. Twenty-nine out of 35 transplant centers (TC) involved in LDKTx responded to the survey (82.9%). Six TCs (21.4%) had a total experience of 20 or fewer LDN. Minimally invasive LDN was the first choice at 24 TC (82.8%). At 10 TC (37.0%) only one surgeon performed LDN. Nineteen TCs (65.5%) had a surgical safety checklist for LDN and 14 had a postoperative surveillance protocol. The renal artery was occluded in 3 TCs (10.3%) mainly by non-transfixion methods (including clips). Redundancy of key safety systems in the operating room was available in 22 of 29 centers (75.8%). In summary, LDKTx should be further implemented in Italy. Donor safety should be improved through the implementation of a national procedural protocol.

Postoperative results, learning curve, and outcomes of pancreatectomy with arterial resection: a single-center retrospective cohort study on 236 procedures.

BACKGROUND: Newer chemotherapy regimens are reviving the role of pancreatectomy with arterial resection (PAR) in locally advanced pancreatic cancer. However, concerns about the early outcomes and learning curve of PAR remain. This study aimed to define the postoperative results and learning curve of PAR and provide preliminary data on oncologic outcomes. MATERIALS AND METHODS: A single center's experiences (1993-2023) were retrospectively analyzed to define the postoperative outcomes and learning curve of PAR. Oncologic results were also reported. RESULTS: During the study period 236 patients underwent PAR. Eighty PAR (33.9%) were performed until 2012, and 156 were performed thereafter (66.1%). Pancreatic cancer was diagnosed histologically in 183 patients (77.5%). Induction therapy was delivered to 18 of these patients (31.0%) in the early experience and to 101 patients (80.8%) in the last decade (P<0.0001). The superior mesenteric artery (PAR-SMA), celiac trunk/hepatic artery (PAR-CT/HA), superior mesenteric/portal vein, and inferior vena cava were resected in 95 (40.7%), 138 (59.2%), 189 (80.1%), and 9 (3.8%) patients, respectively. Total gastrectomy was performed in 35 (18.5%) patients. The thirty-day mortality rate was 7.2% and ninety-day mortality rate was 9.7%. The learning curve for mortality was 106 PAR (16.0% vs. 4.6%; odds ratio, OR=0.25 [0.10-0.67], P=0.0055). Comparison between the PAR-SMA and PAR-CT/HA groups showed no differences in severe postoperative complications (25.3% vs. 20.6%), 90-day mortality (12.6% vs. 7.8%), and median overall survival. Vascular invasion was confirmed in 123 patients (67.2%). The median number (interquartile range) of examined lymph nodes was 60.5 (41.3-83) and rate of R0 resection was 66.1% (121/183). Median overall survival for PAR was 20.9 (12.5-42.8) months, for PAR-SMA was 20.2 (14.4-44) months, and for PAR-CT/HA was 20.2 (11.4-42.7). Long-term prognosis improved by study decade (1993-2002: 12.0 [5.4-25.9] months, 2003-2012: 15.1 [9.8-23.4] months, and 2013-present: 26.2 [14.3-51.5] months; P<0.0001). CONCLUSIONS: In recent times, PAR is associated with improved outcomes despite a steep learning curve. Pancreatic surgeons should be prepared to face the technical challenge posed by PAR.

Controlling and powering a fully implantable artificial pancreas refillable by ingestible pills.

Over the past decade, there has been a growing interest in the development of an artificial pancreas for intraperitoneal insulin delivery. Intraperitoneal implantable pumps guarantee more physiological glycemic control than subcutaneous wearable ones, for the treatment of type 1 diabetes. In this work, a fully implantable artificial pancreas refillable by ingestible pills is presented. In particular, solutions enabling the communication between the implanted pump and external user interfaces and novel control algorithms to intraperitoneally release an adequate amount of insulin based on glycemic data are shown. In addition, the powering and the wireless battery recharging are addressed. Specifically, the design and optimization of a customized transcutaneous energy transfer with two independent wireless channels are presented. The system was tested in terms of recharging efficacy, possible temperature rise within the body, during the recharging process and reliability of the wireless connection in the air and in the presence of ex vivo tissues.Clinical Relevance- This work aims to improve the control, battery recharging, and wireless communication of a fully implantable artificial pancreas for type 1 diabetes treatment.

Ca 125 is an independent prognostic marker in resected pancreatic cancer of the head of the pancreas.

The prognostic value of carbohydrate antigen 125 (Ca 125) is emerging also in pancreatic cancer (PDAC). In this study, we aim to define the prognostic value of Ca 125 in resected PDAC of the head of the pancreas. This is a single-center, retrospective study. Data from patients with a pre-operative assay of Ca 125 who underwent a pancreatic resection for PDAC between 2010 and 2018 were analyzed. As per National Comprehensive Cancer Guidelines, tumors were classified in resectable (R-PDAC), borderline resectable (BR-PDAC), and locally advanced (LA-PDAC). The Kaplan-Meier method was used to evaluate the overall survival. Cox proportional hazard regression was used to evaluate the role of pre-operative Ca 125 in predicting survival (while adjusting for confounders). The maximally selected log-rank statistic was used to identify a Ca 125 cut-off defining two groups with different survival probability. Inclusion criteria were met by 207 patients (R-PDAC: 80, BR-PDAC: 91, and LA-PDAC: 36). Ca 125 predicted overall survival before and after adjusting for confounding factors in all categories of anatomic resectability (R-PDAC: HR = 4.3; p = 0.0249) (BR-PDAC: HR = 7.82; p = 0.0024) (LA-PDAC: HR = 11.4; p = 0.0043). In BR-PDAC and LA-PDAC (n = 127), the division in two groups (high vs. low Ca 125) correlated with T stage (p = 0.0317), N stage (p = 0.0083), mean LN ratio (p = 0.0292), and tumor grading (p = 0.0143). This study confirmed the prognostic value of Ca125 in resected pancreatic cancer and, therefore, the importance of biologic over anatomic resectability. Ca 125 should be routinely assayed in surgical candidates with PDAC.

European Society for Organ Transplantation (ESOT) Consensus Statement on the Role of Pancreas Machine Perfusion to Increase the Donor Pool for Beta Cell Replacement Therapy.

The advent of Machine Perfusion (MP) as a superior form of preservation and assessment for cold storage of both high-risk kidney's and the liver presents opportunities in the field of beta-cell replacement. It is yet unknown whether such techniques, when applied to the pancreas, can increase the pool of suitable donor organs as well as ameliorating the effects of ischemia incurred during the retrieval process. Recent experimental models of pancreatic MP appear promising. Applications of MP to the pancreas, needs refinement regarding perfusion protocols and organ viability assessment criteria. To address the "Role of pancreas machine perfusion to increase the donor pool for beta cell replacement," the European Society for Organ Transplantation (ESOT) assembled a dedicated working group comprising of experts to review literature pertaining to the role of MP as a method of improving donor pancreas quality as well as quantity available for transplant, and to develop guidelines founded on evidence-based reviews in experimental and clinical settings. These were subsequently refined during the Consensus Conference when this took place in Prague.

Practical implications of tumor proximity to landmark vessels in minimally invasive radical antegrade modular pancreatosplenectomy.

Careful preoperative planning is key in minimally invasive radical antegrade modular pancreatosplenectomy (MI-RAMPS). This retrospective study aims to show the practical implications of computed tomography distance between the right margin of the tumor and either the left margin of the spleno-mesenteric confluence (d-SMC) or the gastroduodenal artery (d-GDA). Between January 2011 and June 2022, 48 minimally invasive RAMPS were performed for either pancreatic cancer or malignant intraductal mucinous papillary neoplasms. Two procedures were converted to open surgery (4.3%). Mean tumor size was 31.1 ± 14.7 mm. Mean d-SMC was 21.5 ± 18.5 mm. Mean d-GDA was 41.2 ± 23.2 mm. A vein resection was performed in 10 patients (20.8%) and the pancreatic neck could not be divided by an endoscopic stapler in 19 operations (43.1%). In patients requiring a vein resection, mean d-SMC was 10 mm (1.5-15.5) compared to 18 mm (10-37) in those without vein resection (p = 0.01). The cut-off of d-SMC to perform a vein resection was 17 mm (AUC 0.75). Mean d-GDA was 26 mm (19-39) mm when an endoscopic stapler could not be used to divide the pancreas, and 46 mm (30-65) when the neck of the pancreas was stapled (p = 0.01). The cut-off of d-GDA to safely pass an endoscopic stapler behind the neck of the pancreas was 43 mm (AUC 0.75). Computed tomography d-SMC and d-GDA are key measurements when planning for MI-RAMPS.

The PD-ROBOSCORE: A difficulty score for robotic pancreatoduodenectomy.

BACKGROUND: Difficulty scoring systems are important for the safe, stepwise implementation of new procedures. We designed a retrospective observational study for building a difficulty score for robotic pancreatoduodenectomy. METHODS: The difficulty score (PD-ROBOSCORE) aims at predicting severe postoperative complications after robotic pancreatoduodenectomy. The PD-ROBOSCORE was developed in a training cohort of 198 robotic pancreatoduodenectomies and was validated in an international multicenter cohort of 686 robotic pancreatoduodenectomies. Finally, all centers tested the model during the early learning curve (n = 300). Growing difficulty levels (low, intermediate, high) were defined using cut-off values set at the 33rd and 66th percentile (NCT04662346). RESULTS: Factors included in the final multivariate model were a body mass index of ≥25 kg/m2 for males and ≥30 kg/m2 for females (odds ratio:2.39; P < .0001), borderline resectable tumor (odd ratio:1.98; P < .0001), uncinate process tumor (odds ratio:1.69; P < .0001), pancreatic duct size <4 mm (odds ratio:1.59; P < .0001), American Society of Anesthesiologists class ≥3 (odds ratio:1.59; P < .0001), and hepatic artery originating from the superior mesenteric artery (odds ratio:1.43; P < .0001). In the training cohort, the absolute score value (odds ratio = 1.13; P = .0089) and difficulty groups (odds ratio = 2.35; P = .041) predicted severe postoperative complications. In the multicenter validation cohort, the absolute score value predicted severe postoperative complications (odds ratio = 1.16, P < .001), whereas the difficulty groups did not (odds ratio = 1.94, P = .082). In the learning curve cohort, both absolute score value (odds ratio:1.078, P = .04) and difficulty groups (odds ratio: 2.25, P = .017) predicted severe postoperative complications. Across all cohorts, a PD-ROBOSCORE of ≥12.51 doubled the risk of severe postoperative complications. The PD-ROBOSCORE score also predicted operative time, estimated blood loss, and vein resection. The PD-ROBOSCORE predicted postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, and postoperative mortality in the learning curve cohort. CONCLUSION: The PD-ROBOSCORE predicts severe postoperative complications after robotic pancreatoduodenectomy. The score is readily available via www.pancreascalculator.com.

Tips and tricks for robotic pancreatoduodenectomy with superior mesenteric/portal vein resection and reconstruction.

BACKGROUND: Open pancreatoduodenectomy with vein resection (OPD-VR) is now standard of care in patients who responded to neoadjuvant therapies. Feasibility of robotic pancreatoduodenectomy (RPD) with vein resection (RPD-VR) was shown, but no study provided a detailed description of the technical challenges associated with this formidable operation. Herein, we describe the trips and tricks for technically successful RPD-VR. METHODS: The vascular techniques used in RPD-VR were borrowed from OPD-VR, as well as from our experience with robotic transplantation of both kidney and pancreas. Vein resection was classified into 4 types according to the international study group of pancreatic surgery. Each type of vein resection was described in detail and shown in a video. RESULTS: Between October 2008 and November 2021, a total of 783 pancreatoduodenectomies were performed, including 233 OPDs-VR (29.7%). RPD was performed in 256 patients (32.6%), and RPDs-VR in 36 patients (4.5% of all pancreatoduodenectomies; 15.4% of all pancreatoduodenectomies with vein resection; 14.0% of all RPDs). In RPD-VR vein resections were: 4 type 1 (11.1%), 10 type 2 (27.8%), 12 type 3 (33.3%) and 10 type 4 (27.8%). Vascular patches used in type 2 resections were made of peritoneum (n = 8), greater saphenous vein (n = 1), and deceased donor aorta (n = 1). Interposition grafts used in type 4 resections were internal left jugular vein (n = 8), venous graft from deceased donor (n = 1) and spiral saphenous vein graft (n = 1). There was one conversion to open surgery (2.8%). Ninety-day mortality was 8.3%. There was one (2.8%) partial vein thrombosis, treated with heparin infusion. CONCLUSIONS: We have reported 36 technically successful RPDs-VR. We hope that the tips and tricks provided herein can contribute to safer implementation of RPD-VR. Based on our experience, and according to data from the literature, we strongly advise that RPD-VR is performed by expert surgeons at high volume centers.

Feasibility of "cold" triangle robotic pancreatoduodenectomy.

BACKGROUND: Triangle pancreatoduodenectomy adds to the conventional procedure the en bloc removal of the retroperitoneal lympho-neural tissue included in the triangular area bounded by the common hepatic artery (CHA), the superior mesenteric artery (SMA), and the superior mesenteric vein/portal vein. We herein aim to show the feasibility of "cold" triangle robotic pancreaticoduodenectomy (C-Tr-RPD) for pancreatic cancer (PDAC). METHODS: Cold dissection corresponds to sharp arterial divestment performed using only the tips of robotic scissors. After division of the gastroduodenal artery, triangle dissection begins by lateral-to-medial divestment of the CHA and anterior-to-posterior clearance of the right side of the celiac trunk. Next, after a wide Kocher maneuver, the origin of the SMA, and the celiac trunk are identified. After mobilization of the first jejunal loop and attached mesentery, the SMA is identified at the level of the first jejunal vein and is divested along the right margin working in a distal-to-proximal direction. Vein resection and reconstruction can be performed as required. C-Tr-RPD was considered feasible if triangle dissection was successfully completed without conversion to open surgery or need to use energy devices. Postoperative complications and pathology results are presented in detail. RESULTS: One hundred twenty-seven consecutive C-Tr-RPDs were successfully performed. There were three conversions to open surgery (2.3%), because of pneumoperitoneum intolerance (n = 2) and difficult digestive reconstruction. Thirty-four patients (26.7%) required associated vascular procedures. No pseudoaneurysm of the gastroduodenal artery was observed. Twenty-eight patients (22.0%) developed severe postoperative complications (≥ grade III). Overall 90-day mortality was 7.1%, declining to 2.3% after completion of the learning curve. The median number of examined lymph nodes was 42 (33-51). The rate of R1 resection (7 margins < 1 mm) was 44.1%. CONCLUSION: C-Tr-RPD is feasible, carries a risk of surgical complications commensurate to the magnitude of the procedure, and improves staging of PDAC.

Outcomes of double-layer continuous suture hepaticojejunostomy in pancreatoduodenectomy and total pancreatectomy.

BACKGROUND: This study aims to describe the technique and the results of double-layer continuous suture hepaticojejunostomy (HJ) following pancreatoduodenectomy (PD) and total pancreatectomy (TP). METHODS: A prospectively maintained database was analyzed retrospectively to identify incidence and severity of biliary leaks (BL) (ISGLS definition), as well as of HJ stenosis (HJS), cholangitis, and need for redo-HJ (in patients with a follow-up ≥3 years) in a consecutive series of 800 procedures (PD = 603; TP = 197). Predictors of biliary complications were also identified. RESULTS: BLs occurred in 5 patients (0.6%), including 2 (0.3%) combined pancreatic and biliary leaks. Rates of HJS, cholangitis, and need for redo-HJ were 6.1%, 5.4%, and 2.0%, respectively. Incidence of BL was 0.6% in open procedures (4/587) and 0.4% in robotic operations (1/213). Incidence of late biliary complications was also equivalent in open and robotic procedures. Occurrence of BL was predicted by ASA IV status and duodenal cancer, HJS by any associated vascular procedure and hepatic duct size < 8 mm, cholangitis by any associated vascular procedure and normal bilirubin/hepatic enzymes, and redo HJ by history of cholecystectomy and neuroendocrine tumor/cancer. DISCUSSION: Double layer continuous suture HJ is associated with low BL rates, and an acceptable incidence of late complications.

Artificial intelligence applications for pre-implantation kidney biopsy pathology practice: a systematic review.

BACKGROUND: Transplant nephropathology is a highly specialized field of pathology comprising both the evaluation of organ donor biopsy for organ allocation and post-transplant graft biopsy for assessment of rejection or graft damage. The introduction of digital pathology with whole-slide imaging (WSI) in clinical research, trials and practice has catalyzed the application of artificial intelligence (AI) for histopathology, with development of novel machine-learning models for tissue interrogation and discovery. We aimed to review the literature for studies specifically applying AI algorithms to WSI-digitized pre-implantation kidney biopsy. METHODS: A systematic search was carried out in the electronic databases PubMed-MEDLINE and Embase until 25th September, 2021 with a combination of the key terms "kidney", "biopsy", "transplantation" and "artificial intelligence" and their aliases. Studies dealing with the application of AI algorithms coupled with WSI in pre-implantation kidney biopsies were included. The main theme addressed was detection and quantification of tissue components. Extracted data were: author, year and country of the study, type of biopsy features investigated, number of cases, type of algorithm deployed, main results of the study in terms of diagnostic outcome, and the main limitations of the study. RESULTS: Of 5761 retrieved articles, 7 met our inclusion criteria. All studies focused largely on AI-based detection and classification of glomerular structures and to a lesser extent on tubular and vascular structures. Performance of AI algorithms was excellent and promising. CONCLUSION: All studies highlighted the importance of expert pathologist annotation to reliably train models and the need to acknowledge clinical nuances of the pre-implantation setting. Close cooperation between computer scientists and practicing as well as expert renal pathologists is needed, helping to refine the performance of AI-based models for routine pre-implantation kidney biopsy clinical practice.

Treating Type 1 Diabetes by Pancreas Transplant Alone: A Cohort Study on Actual Long-term (10 Years) Efficacy and Safety.

BACKGROUND: Physiologically regulated insulin secretion and euglycemia are achievable in type 1 diabetes (T1D) by islet or pancreas transplantation. However, pancreas transplant alone (PTA) remains a debated approach, with uncertainties on its relative benefits and risks. We determined the actual long-term (10 y) efficacy and safety of PTA in carefully characterized T1D subjects. METHODS: This is a single-center, cohort study in 66 consecutive T1D subjects who received a PTA between April 2001 and December 2007, and were then all followed until 10 y since transplant. Main features evaluated were patient survival, pancreas graft function, C-peptide levels, glycemic parameters, and the function of the native kidneys. RESULTS: Ten-year actual patient survival was 92.4%. Optimal (insulin independence) or good (minimal insulin requirement) graft function was observed in 57.4% and 3.2% of patients, respectively. Six (9.0%) patients developed stage 5 or 4 chronic kidney disease. In the remaining individuals bearing a successful PTA, estimated glomerular filtration rate (eGFR) decline per year was -2.29 ± 2.69 mL/min/1.73 m2. Reduction of eGFR at 1 y post-PTA was higher in those with pre-PTA hyperfiltration and higher HbA1c concentrations; eGFR changes afterward significantly correlated with diabetes duration. In recipients with normoglycemia at 10 y, 74% of normoalbuminuric or microalbuminuric subjects pre-PTA remained stable, and 26% progressed toward a worse stage; conversely, in 62.5% of the macroalbuminuric individuals albuminuria severity regressed. CONCLUSIONS: These long-term effects of PTA on patient survival, graft function, and the native kidneys support PTA as a suitable approach to treat diabetes in selected T1D patients.

Primary Perivascular Epithelioid Cell Tumor (PEComa) of the Ovary: A Case Report and Review of the Literature.

BACKGROUND: Perivascular epithelioid cell tumors (PEComa)s are mesenchymal neoplasms located at various anatomic sites, which usually express both melanocytic and myogenic markers. CASE REPORT: A 60-year-old woman underwent laparotomy for a huge, heterogeneous, right ovarian mass. The histological examination of the surgical specimen revealed a neoplasm consisting of both cells with clear or eosinophilic cytoplasm and spindle cells in a myxoid stroma. Immunostaining was positive for human melanoma black-45, h-caldesmon, desmin, actin, and transcription factor 3. Cell atypias were moderate, mitoses were 4/10 high power fields (HPF) and margins were focally infiltrative. These findings pointed to a diagnosis of ovarian PEComa. Twenty-five months later, two subcutaneous lesions were surgically removed on the left trapezius muscle and the median subumbilical area, respectively. The former was a desmoid fibromatosis, whereas the latter was a recurrence of PEComa with greater nuclear pleomorphism and higher number of mitoses (26/50 HPF) compared to the primary tumor. The patient was free of disease 11 months later. CONCLUSION: A long-term follow-up of gynecological PEComas is strongly recommended.

A fully implantable device for intraperitoneal drug delivery refilled by ingestible capsules.

Creating fully implantable robots that replace or restore physiological processes is a great challenge in medical robotics. Restoring blood glucose homeostasis in patients with type 1 diabetes is particularly interesting in this sense. Intraperitoneal insulin delivery could revolutionize type 1 diabetes treatment. At present, the intraperitoneal route is little used because it relies on accessing ports connecting intraperitoneal catheters to external reservoirs. Drug-loaded pills transported across the digestive system to refill an implantable reservoir in a minimally invasive fashion could open new possibilities in intraperitoneal delivery. Here, we describe PILLSID (PILl-refiLled implanted System for Intraperitoneal Delivery), a fully implantable robotic device refillable through ingestible magnetic pills carrying drugs. Once refilled, the device acts as a programmable microinfusion system for precise intraperitoneal delivery. The robotic device is grounded on a combination of magnetic switchable components, miniaturized mechatronic elements, a wireless powering system, and a control unit to implement the refilling and control the infusion processes. In this study, we describe the PILLSID prototyping. The device key blocks are validated as single components and within the integrated device at the preclinical level. We demonstrate that the refilling mechanism works efficiently in vivo and that the blood glucose level can be safely regulated in diabetic swine. The device weights 165 grams and is 78 millimeters by 63 millimeters by 35 millimeters, comparable with commercial implantable devices yet overcoming the urgent critical issues related to reservoir refilling and powering.

First world consensus conference on pancreas transplantation: Part I-Methods and results of literature search.

Comprehensive evidence-based guidelines for the practice of pancreas transplantation are yet to be established. The First World Consensus Conference on Pancreas Transplantation was convened for this purpose. A steering committee selected the participants and defined the questions to be addressed. A group of literature reviewers identified 597 studies to be included in summaries for guidelines production. Expert groups formulated the first draft of recommendations. Two rounds of discussion and voting occurred online, using the Delphi method (agreement rate ≥85%). After each round, critical responses of experts were reviewed, and recommendations were amended accordingly. Recommendations were finalized after live discussions. Each session was preceded by expert presentations and a summary of results of systematic literature review. Up to three voting rounds were allowed for each recommendation. To avoid potential conflicts of interest, deliberations on issues regarding the impact of pancreas transplantation on the management of diabetes were conducted by an independent jury. Recommendations on technical issues were determined by experts and validated using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Quality of evidence was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) methodology. Each recommendation received a GRADE rating (Grading of Recommendations, Assessment, Development and Evaluations).