27 research outputs found

    Current Role of Minimally Invasive Radical Cholecystectomy for Gallbladder Cancer

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    Background. For Tis and T1a gallbladder cancer (GbC), laparoscopic cholecystectomy can provide similar survival outcomes compared to open cholecystectomy. However, for patients affected by resectable T1b or more advanced GbC, open approach radical cholecystectomy (RC), consisting in gallbladder liver bed resection or segment 4b-5 bisegmentectomy, with locoregional lymphadenectomy, is considered the gold standard while minimally invasive RC (MiRC) is skeptically considered. Aim. To analyze current literature on perioperative and oncologic outcomes of MiRC for patients affected by GbC. Methods. A Medline review of published articles until June 2016 concerning MiRC for GbC was performed. Results. Data relevant for this review were presented in 13 articles, including 152 patients undergoing an attempt of MiRC for GbC. No randomized clinical trial was found. The approach was laparoscopic in 147 patients and robotic in five. Conversion was required in 15 (10%) patients. Postoperative complications rate was 10% with no mortality. Long-term survival outcomes were reported by 11 studies, two of them showing similar oncologic results when comparing MiRC with matched open RC. Conclusions. Although randomized clinical trials are still lacking and only descriptive studies reporting on limited number of patients are available, current literature seems suggesting that when performed at highly specialized centers, MiRC for GbC is safe and feasible and has oncologic outcomes comparable to open RC

    Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2):study protocol for an international multicenter patient-blinded randomized controlled trial

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    Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023.</p

    The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS)

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    Objective: To develop and update evidence-based and consensus-based guidelines on laparoscopic and robotic pancreatic surgery. Summary Background Data: Minimally invasive pancreatic surgery (MIPS), including laparoscopic and robotic surgery, is complex and technically demanding. Minimizing the risk for patients requires stringent, evidence-based guidelines. Since the International Miami Guidelines on MIPS in 2019, new developments and key publications have been reported, necessitating an update. Methods: Evidence-based guidelines on 22 topics in 8 domains were proposed: terminology, indications, patients, procedures, surgical techniques and instrumentation, assessment tools, implementation and training, and artificial intelligence. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS, September 2022) used the Scottish Intercollegiate Guidelines Network (SIGN) methodology to assess the evidence and develop guideline recommendations, the Delphi method to establish consensus on the recommendations among the Expert Committee, and the AGREE II-GRS tool for guideline quality assessment and external validation by a Validation Committee. Results: Overall, 27 European experts, 6 international experts, 22 international Validation Committee members, 11 Jury Committee members, 18 Research Committee members, and 121 registered attendees of the 2-day meeting were involved in the development and validation of the guidelines. In total, 98 recommendations were developed, including 33 on laparoscopic, 34 on robotic, and 31 on general MIPS, covering 22 topics in 8 domains. Out of 98 recommendations, 97 reached at least 80% consensus among the experts and congress attendees, and all recommendations were externally validated by the Validation Committee. Conclusions: The EGUMIPS evidence-based guidelines on laparoscopic and robotic MIPS can be applied in current clinical practice to provide guidance to patients, surgeons, policy-makers, and medical societies.</p

    Pancreatic surgery in Italy. Criteria to identify the hospital units and the tertiary referral centers entitled to perform it

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    Indicators of effectiveness and quality of care are urgently needed to improve the surgical outcomes. This is particularly felt in the field of complex surgical fields, such as the HPB one. International and national studies have documented an association between the large number of pancreatic surgical procedures and the outcome quality. The aim of this paper is to suggest reliable structural requirements and surgical volume to support pancreatic surgical accreditation, preserving patient's safety. Moreover, an accreditation program is outlined

    La cardiomiopatia aritmogena del ventricolo destro nel Bulldog Inglese: Una patologia emergente

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    Arrhythmogenic right ventricular cardiomyopathy is a familial heart disease characterized by a progressive replacement of myocardium with fibro-fatty tissue. These structural changes are accompanied by functional changes with the onset of ventricular arrhythmias and myocardial dysfunction. In veterinary medicine, this disease has been reported sporadically in several canine and feline breeds, while in the Boxer breed the ultra-structural alterations, genetic transmission, and clinical and instrumental findings of the disease have been extensively described. Recently arrhythmogenic right ventricular cardiomyopathy has also been recognized in the English Bulldog, with distinctive features such as the presence of monomorphic ventricular tachycardia with left bundle branch block morphology and an incessant behaviour and the presence, in two thirds of affected dogs, of a segmental form with aneurysms of the right ventricular outflow tract. The purpose of the present manuscript is to describe clinical and instrumental findings of this disease in English Bulldog comparing them with those reported in Boxer breed dogs

    Implementation of a strategic preoperative surgical meeting to improve the level of care at a high-volume pancreatic center: a before-after analysis of 1000 consecutive cases

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    The indication, planning, and risk analysis of a pancreatic surgical procedure have recently become increasingly complex. In December 2015, the "Pancreas Round" (PR) meeting was established at our institution to preoperatively review all scheduled cases with a specific focus on surgical indications and technical issues. The present study aims to determine the impact of the PR on the clinical practice in terms of avoiding unrequested laparotomies and anticipating intraoperative pitfalls. A "before-after" study was conducted by retrospectively comparing a pre-intervention period (9/2014-11/2015) to a prospectively assessed post-intervention one (12/2015-3/2017). Outcomes considered were explorative laparotomy (EL) occurrence and a "mismatch" between what was preoperatively expected by the PR and what was intraoperatively found. Of the 1057 patients included in the present study, 531 underwent surgery in the pre- and 526 in the post-intervention period, respectively. The EL rate was comparable between the two periods (15.4% vs. 12.2%, p\u2009=\u20090.123), despite the significant increase of surgical explorations after neoadjuvant chemotherapy during the post-intervention period (27% vs. 18%, p\u2009&lt;\u20090.001). The "mismatch" rate between preoperative planning and intraoperative findings was significantly reduced in the post-intervention period (12.2% vs. 8.4%, p\u2009=\u20090.038) compared to the pre-PR period. In the setting of a high-volume center, a preoperative surgical meeting designed to review all cases scheduled for surgical exploration can enhance the level of care by addressing intraoperative pitfalls

    Minimally invasive pancreatic surgery - a review

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    During the past 20 years the application of a minimally invasive approach to pancreatic surgery has progressively increased. Distal pancreatectomy is the most frequently performed procedure, because of the absence of a reconstructive phase. However, middle pancreatectomy and pancreatoduodenectomy have been demonstrated to be safe and feasible as well. Laparoscopic distal pancreatectomy is recognized as the gold standard treatment for small tumors of the pancreatic body-tail, with several advantages over the traditional open approach in terms of patient recovery. The surgical treatment of lesions of the pancreatic head via a minimally invasive approach is still limited to a few highly experienced surgeons, due to the very challenging resection and complex anastomoses. Middle pancreatectomy and enucleation are indicated for small and benign tumors and offer the maximum preservation of the parenchyma. The introduction of a robotic platform more than ten years ago increased the interest of many surgeons in minimally invasive treatment of pancreatic diseases. This new technology overcomes all the limitations of laparoscopic surgery, but actual benefits for the patients are still under investigation. The increased costs associated with robotic surgery are under debate too. This article presents the state of the art of minimally invasive pancreatic surgery

    Local Ablative Strategies for Ductal Pancreatic Cancer (Radiofrequency Ablation, Irreversible Electroporation): A Review

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    Pancreatic ductal adenocarcinoma (PDAC) has still a dismal prognosis. Locally advanced pancreatic cancer (LAPC) accounts for the 40% of the new diagnoses. Current treatment options are based on chemo- and radiotherapy regimens. Local ablative techniques seem to be the future therapeutic option for stage-III patients with PDAC. Radiofrequency Ablation (RFA) and Irreversible Electroporation (IRE) are actually the most emerging local ablative techniques used on LAPC. Initial clinical studies on the use of these techniques have already demonstrated encouraging results in terms of safety and feasibility. Unfortunately, few studies on their efficacy are currently available. Even though some reports on the overall survival are encouraging, randomized studies are still required to corroborate these findings. This study provides an up-to-date overview and a thematic summary of the current available evidence on the application of RFA and IRE on PDAC, together with a comparison of the two procedures

    Pancreaticoduodenectomy for distal cholangiocarcinoma: surgical results, prognostic factors, and long-term follow-up

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    Purpose Prognostic indicators for distal cholangiocarcinoma have not been widely confirmed because of its rarity. Despite the early appearance of symptoms, it has a very poor prognosis. The aim of this study was to identify prognostic factors in patients undergoing pancreaticoduodenectomy (PD) for distal bile duct cancer (DBDC) in a high-volume center for pancreatic disease. Methods From January 2000 to December 2013, 1490 PD were performed for periampullary disease. Data from all patients with histologically proven cholangiocarcinoma were reviewed. Preoperative data, post-operative complications, pathologic features, and survival were investigated. Results Among 50 histologically proven DBDC (3.3 %), 4 patients who underwent CBD resection were excluded. Thus, the study population consisted of 46 patients. Overall surgical morbidity rate was 67.4 %; mortality was nil. Major complications were pancreatic fistula (47.8 %), abdominal collections (34.8 %), post-pancreatectomy hemorrhage (21.7 %), and delayed gastric emptying (10.9 %). The majority of resections were R0 (73.9 %). The presence of metastatic lymph nodes (N1) was identified in 76.1 % of cases. Among N1 cases, the most frequently involved lymph nodes were pancreaticoduodenal nodes (50 %), hepatoduodenal ligament nodes (21.7 %), superior mesenteric artery nodes (8.7 %), and anterior hepatic artery nodes (4.3 %). Overall, survival rates were 88.8, 40, and 18 % at 1, 3, and 5 years, respectively. Median survival was 31 months. By univariate analysis, only tumor grading and nodal metastasis were predictors of poor prognosis (p&lt;0.05). These findings were not confirmed in multivariate analysis. Conclusions This study shows that DBDC is a rare entity even if large surgical series are reviewed. Tumor differentiation and nodal status have been confirmed as important prognostic factors. Pancreaticoduodenectomy remains the procedure of choice in order to obtain free surgical margins and in order to harvest the correct number of lymph nodes for a correct staging
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