79 research outputs found

    Risk stratification tools for branch-duct intraductal papillary mucinous neoplasms of the pancreas

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    Prediction models have been built to improve the correct identification of high‐risk IPMNs and thus the selection of patients for surgery. However, there are currently no tools to recommend the best IPMN surveillance strategy and to distinguish those who might not warrant surveillance at all

    The use of a smartphone application to disseminate guidelines on pancreatic cystic neoplasms

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    Officially release in October 2019, iCyst was developed as part of the project entitled “Current application of the European evidence‐based guidelines on pancreatic cystic tumors”, which was promoted by the Department of General and pancreatic Surgery – The Pancreas Institute, University of Verona Hospital Trust (Institutional Review Board approval number 2390CESC – Comitato Etico delle Province di Verona e Rovigo), and received funding from the United European Gastroenterology Activity Grants – Support of Standards & Guidelines initiatives, dissemination of existing clinical practice 2019 (endorse by the European Digestive Surgery – EDS)

    Early and Sustained Elevation in Serum Pancreatic Amylase Activity: A Novel Predictor of Morbidity After Pancreatic Surgery

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    Objective:To characterize early postoperative serum pancreatic amylase (spAMY) trends after pancreatic resections. Summary Background Data:A postoperative spAMY elevation is a common finding but uncertainties remain about its meaning and prognostic implications. Methods:Analysis of patients who consecutively underwent pancreatectomy from 2016 to 2019. spAMY activity was assessed from postoperative day (POD) 0 to 3. Different patterns of spAMY have been identified based on the spAMY standard range (10-52 U/l). Results:Three patterns were identified: (#1) spAMY values always < the lower limit of normal/within the reference range /a single increase in spAMY > upper limit of normal at any POD; (#2) Sustained increase in spAMY activity on POD 0 + 1; (#3) Sustained increase in spAMY activity including POD 1 + 2. Shifting through spAMY patterns was associated with increase morbidity (21% in #1 to 68% in #3 at POD 7; log rank < 0.001). Almost all severe complications (at least Clavien-Dindo >= 3) occurred in patients with pattern #3 (15% vs 3% vs 5% in #1 and #2 at POD 7, P = 0.006), without difference considering >3-times or >the spAMY normal limit (P = 0.85). POPF (9% in #1 vs 48% in #3, P < 0.001) progressively increased across patterns. Pre-operative diabetes (OR 0.19), neoadjuvant therapy (OR 0.22), pancreatic texture (OR 8.8), duct size (OR 0.78), and final histology (OR 2.2) were independent predictors of pattern #3. Conclusions:A sustained increase in spAMY activity including POD 1 + 2 (#3) represents an early postoperative predictor of overall and severe early morbidity. An early and dynamic evaluation of spAMY could crucially impact the subsequent clinical course with relevant prognostic implications

    preoperative therapy with trastuzumab and oral vinorelbine endocrine therapy in patients with her2 positive breast cancer

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    Abstract Background Combined trastuzumab and intravenous vinorelbine yielded high clinical activity as preoperative treatment in patients (pts) with HER 2/ neu positive breast cancer. Patients and methods We tested a preoperative combination of trastuzumab with oral vinorelbine (oV) in pts with locally advanced (T2-T4 N0-3 M0) HER2-positive breast cancer. Trastuzumab was administered i.v q 3 wks and oV was administered at the dose of 55 mg/sqm on days 1 and 3 q 3 wks, for 8 courses. Pts with ER ≄ 10% tumors received endocrine therapy with letrozole 2.5 mg/day, plus monthly triptorelin if premenopausal. Results Forty-five pts entered the study. The overall response rate (CR + PR) was 76% (95% CI: 60%–87%). pCR was observed in 4 pts (10%). Among ER-positive tumors 21/25 pts obtained a clinical response (84%) and two pts obtained a pCR (8%). Conclusions The combination of trastuzumab and oral vinorelbine demonstrated encouraging activity in patients with HER 2 positive ER-positive tumors. Alternative strategies should be investigated in patients with endocrine non responsive disease

    increased mean corpuscular volume of red blood cells predicts response to metronomic capecitabine and cyclophosphamide in combination with bevacizumab

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    Abstract Background There is an urgent need for the identification of commonly assessable predictive factors in the treatment of patients with metastatic breast cancer. Methods During the course of a treatment including low dose metronomic oral cyclophosphamide and capecitabine plus i.v. bevacizumab (plus erlotinib in one third of the patients) for metastatic breast cancer, we observed that a relevant number of patients developed repeatedly elevated levels of mean corpuscular volume (MCV) of red blood cells without a significant fall in hemoglobin levels. We conducted a retrospective analysis on these 69 patients to evaluate if the increase in MCV could be associated to tumor response. Results During the course of treatment 42 out of 69 patients (61%) developed macrocytosis. Using Cox proportional hazards modeling that incorporated macrocytosis (MCV≄100 fl) as a time-dependent covariate, macrocytosis resulted in a halved risk of disease progression (HR 0.45; 95% CI, 0.22–0.92, p-value 0.028). In a landmark analysis limited to patients with no sign of progression after 24 weeks of treatment, median time to progression was 72 weeks (48 weeks after landmark) in patients who had developed macrocytosis, and 43 weeks (19 weeks after landmark) in patients who had not (p = 0.023). Conclusion Macrocytosis inversely related to risk of disease progression in patients treated with metronomic capecitabine plus cyclophosphamide and bevacizumab for metastatic breast cancer. This finding may be explained through thymidylate synthase inhibition by capecitabine. Whether bevacizumab has a role in determining macrocytosis, similarly to what happens with sunitinib, has to be further investigated. If other studies will confirm our findings, macrocytosis might be used as an early marker of response during metronomic treatment with capecitabine and cyclophosphamide with or without bevacizumab

    Surgical and Oncological Outcomes After Preoperative FOLFIRINOX Chemotherapy in Resected Pancreatic Cancer : An International Multicenter Cohort Study

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    Background. Preoperative FOLFIRINOX chemotherapy is increasingly administered to patients with borderline resectable (BRPC) and locally advanced pancreatic cancer (LAPC) to improve overall survival (OS). Multicenter studies reporting on the impact from the number of preoperative cycles and the use of adjuvant chemotherapy in relation to outcomes in this setting are lacking. This study aimed to assess the outcome of pancreatectomy after preoperative FOLFIRINOX, including predictors of OS.Methods. This international multicenter retrospective cohort study included patients from 31 centers in 19 European countries and the United States undergoing pancreatectomy after preoperative FOLFIRINOX chemotherapy (2012-2016). The primary end point was OS from diagnosis. Survival was assessed using Kaplan-Meier analysis and Cox regression.Results. The study included 423 patients who underwent pancreatectomy after a median of six (IQR 5-8) preoperative cycles of FOLFIRINOX. Postoperative major morbidity occurred for 88 (20.8%) patients and 90-day mortality for 12 (2.8%) patients. An R0 resection was achieved for 243 (57.4%) patients, and 259 (61.2%) patients received adjuvant chemotherapy. The median OS was 38 months (95% confidence interval [CI] 34-42 months) for BRPC and 33 months (95% CI 27-45 months) for LAPC. Overall survival was significantly associated with R0 resection (hazard ratio [HR] 1.63; 95% CI 1.20-2.20) and tumor differentiation (HR 1.43; 95% CI 1.08-1.91). Neither the number of preoperative chemotherapy cycles nor the use adjuvant chemotherapy was associated with OS.Conclusions. This international multicenter study found that pancreatectomy after FOLFIRINOX chemotherapy is associated with favorable outcomes for patients with BRPC and those with LAPC. Future studies should confirm that the number of neoadjuvant cycles and the use adjuvant chemotherapy have no relation to OS after resection.Peer reviewe

    Added value of 3D-vision during robotic pancreatoduodenectomy anastomoses in biotissue (LAEBOT 3D2D): a randomized controlled cross-over trial

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    Background: We tested the added value of 3D-vision on procedure time and surgical performance during robotic pancreatoduodenectomy anastomoses in biotissue. Robotic surgery has the advantage of articulating instruments and 3D-vision. Consensus is lacking on the added value of 3D-vision during laparoscopic surgery. Given the improved dexterity with robotic surgery, the added value of 3D-vision may be even less with robotic surgery. Methods: In this experimental randomized controlled cross-over trial, 20 surgeons and surgical residents from 5 countries performed robotic pancreaticojejunostomy and hepaticojejunostomy anastomoses in a biotissue organ model using the da VinciÂź system and were randomized to start with either 3D- or 2D-vision. Primary endpoint was the time required to complete both anastomoses. Secondary endpoint was the objective structured assessment of technical skill (OSATS; range 12–60) rating; scored by two observers blinded to 3D/2D. Results: Robotic 3D-vision reduced the combined operative time from 78.1 to 57.3 min (24.6% reduction, p < 0.001; 20.8 min reduction, 95% confidence intervals 12.8–28.8 min). This reduction was consistent for both anastomoses and between surgeons and residents, p < 0.001. Robotic 3D-vision improved OSATS performance by 6.1 points (20.8% improvement, p = 0.003) compared to 2D (39.4 to 45.1 points, ± 5.5). Conclusion: 3D-vision has a considerable added value during robotic pancreatoduodenectomy anastomoses in biotissue in both time reduction and improved surgical performance as compared to 2D-vision
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