Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer

Background: Malnutrition and cachexia are common in patients with advanced pancreatic ductal adenocarcinoma (PDAC) and have a significant influence on the tolerance and response to treatments. If timely identified, malnourished PDAC patients could be treated to increase their capacity to complete the planned treatments and, therefore, possibly, improve their efficacy. Aims: The aim of this study is to assess the impact of nutritional status, pancreatic exocrine insufficiency (PEI), and other clinical factors on patient outcomes in patients with advanced PDAC. Methods: PAncreatic Cancer MAlnutrition and Pancreatic Exocrine INsufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer (PAC-MAIN) is an international multicenter prospective observational cohort study. The nutritional status will be determined by means of Mini-Nutritional Assessment score and laboratory blood tests. PEI will be defined by reduced fecal elastase levels. MAIN OUTCOME: adherence to planned chemotherapy in the first 12 weeks following the diagnosis, according to patients' baseline nutritional status and quantified and reported as "percent of standard chemotherapy dose delivered." SECONDARY OUTCOMES: rate of chemotherapy-related toxicity, progression-free survival, survival at 6 months, overall survival, quality of life, and the number of hospitalizations. ANALYSIS: chemotherapy dosing over the first 12 weeks of therapy (i.e., percent of chemotherapy received in the first 12 weeks, as defined above) will be compared between well-nourished and malnourished patients. SAMPLE SIZE: based on an expected percentage of chemotherapy delivered of 70% in well-nourished patients, with a type I error of 0.05 and a type II error of 0.20, a sample size of 93 patients per group will be required in case of a percentage difference of chemotherapy delivered of 20% between well-nourished and malnourished patients, 163 patients per group in case of a difference of 15% between the groups, and 356 patients per group in case of a 10% difference. Centers from Russia, Romania, Turkey, Spain, Serbia, and Italy will participate in the study upon Local Ethics Committee approval. Discussion: PAC-MAIN will provide insights into the role of malnutrition and PEI in the outcomes of PDAC. The study protocol was registered at clinicaltrials.gov as NCT04112836

Analysis of landrace cultivation in Europe: A means to support in situ conservation of crop diversity

During the last century, the progressive substitution of landraces with modern, high yielding varieties, led to a dramatic reduction of in situ conserved crop diversity in Europe. Nowadays there is limited and scattered information on where landraces are cultivated. To fill this gap and lay the groundwork for a regional landrace in situ conservation strategy, information on more than 19,335 geo-referenced landrace cultivation sites were collated from 14 European countries. According to collected data, landraces of 141 herbaceous and 48 tree species are cultivated across Europe: Italy (107 species), Greece (93), Portugal (45) and Spain (44) hold the highest numbers. Common bean, onion, tomato, potato and apple are the species of main interest in the covered countries. As from collected data, about 19.8% of landrace cultivation sites are in protected areas of the Natura 2000 network. We also got evidence that 16.7% and 19.3% of conservation varieties of agricultural species and vegetables are currently cultivated, respectively. Results of the GIS analysis allowed the identification of 1261 cells (25 km × 25 km) including all the cultivation sites, distributed across all European biogeographical regions. Data of this study constitute the largest ever produced database of in situ-maintained landraces and the first attempt to create an inventory for the entire Europe. The availability of such resource will serve for better planning of actions and development of policies to protect landraces and foster their use

Anatomy of Major Duodenal Papilla Influences ERCP Outcomes and Complication Rates: A Single Center Prospective Study

Background: Endoscopic retrograde cholangiopancreatography (ERCP) has been one of the most intensely studied endoscopic procedures due to its overall high complication rates when compared to other digestive endoscopy procedures. The safety and outcome of such procedures have been linked to multiple procedure- or patient-related risk factors. The aim of our study is to evaluate whether the morphology of the major duodenal papilla influences the ERCP outcomes and complication rates. Methods: A total of 322 patients with a native papilla have been included in the study over an eight month period. Morphology of the papilla has been classified into normal papilla and four anatomical variations (Type I-IV). All patients have been prospectively monitored over a 15 day period after ERCP. Procedural outcomes and complication rates have been registered. Results: Morphology of the papilla influences both overall complication rates (95%CI, p = 0.0066) and post-ERCP pancreatitis rates (95%CI, p = 0.01001) in univariate analysis. Type IV papillae have proven to be independent risk factors for post-ERCP pancreatitis in multivariate analysis (OR = 12.176, 95%CI, p = 0.005). Type I papillae have been significantly linked to difficult cannulation (AUC = 0.591, 95%CI, p = 0.008); Conclusions: In the monitored cohort morphology of the major duodenal papilla has significantly influenced both ERCP outcomes and post-procedural complication rates

Endoscopic Management of Biliary Strictures after Orthotopic Liver Transplantation: A Single Center Experience Study

Background and Aim. Endoscopic therapy is the method of choice in the management of biliary strictures after orthotopic liver transplantation (OLT). Even though the mainstay approach for OLT stricture complications is represented by consecutive procedures of multiple plastic stents (MPS) insertion, a valuable alternative is the use of fully covered self-expandable metal stents (FCSEMS). The aim of the study was to compare MPS with FCSEMS used in the management of OLT biliary strictures, in terms of clinical outcomes and complications. Material and Methods. This is a retrospective, single-center study conducted between February 2014 and November 2019 in the Clinical Emergency Hospital of Bucharest, Romania. We enrolled all consecutive patients who developed biliary strictures after OLT and were treated by endoscopic retrograde cholangiopancreatography (ERCP) either with MPS or FCSEMS. Results. Thirty-six patients were included in the study, 27 patients had MPS and nine patients had FCSEMS. 106 ERCP procedures were performed and 159 stents were inserted. The mean number of ERCP procedures required per patient was significantly higher for MPS than for FCSEMS (3.34 ± 1.46 vs. 2.11 ± 0.33, p < 0.001). In the FCSEMS group only one patient had three procedures, due to stent migration. Difficult cannulation was encountered in 22 patients, 18 patients from MPS group and four patients from FCSEMS group. Dilation was performed in 20 (77%) MPS patients and in four FCSEMS patients (44%). Overall, we used 159 stents for stricture resolution, 149 plastic stents and 10 FCSEMS. Mean number of stents inserted was significantly lower in the FCSEMS group compared to MPS group (1.16 ± 0.40 vs. 5.73 ± 2.64, p < 0.001). Conclusions. Stricture resolution using FCSEMS is comparable to MPS and even has some advantages. In line with prior studies, FCSEMS are effective, with fewer complications and similar outcome compared to plastic stents. Other particular aspects should be further assessed, especially long-term follow up of FCSEMS and their cost efficiency

Efficacy of Endobiliary Radiofrequency Ablation in Preserving Survival, Performance Status and Chemotherapy Eligibility of Patients with Unresectable Distal Cholangiocarcinoma: A Case-Control Study

Background: Cholangiocarcinoma is the most common malignancy of the bile ducts causing intrahepatic, hilar, or distal bile duct obstruction. Most jaundiced patients are diagnosed with unresectable tumors in need for palliative bile duct drainage and chemotherapy. Endobiliary radiofrequency ablation (RFA) is an adjuvant technique that may be applied prior to biliary stenting. The aim of our study was to assess the efficacy of endobiliary RFA prior to stent insertion in patients with unresectable distal cholangiocarcinomas. Methods: Twenty-five patients (eight treated with RFA and stenting and 17 treated with stenting alone) were included in a case-controlled study. We prospectively assessed the impact of RFA on the survival rate, the patient performance status, and the preservation of eligibility for chemotherapy based on the patient laboratory profile. Results: Patients treated with RFA prior to stenting proved to have a significantly longer survival interval (19 vs. 16 months, p = 0.04, 95% CI) and significantly better performance status. Moreover, the laboratory profiles of patients treated with RFA has been proven superior in terms of total bilirubin, liver enzymes, and kidney function, thus making patients likely eligible for palliative chemotherapy. Post-ERCP adverse events were scarce in both the study group and the control group. Conclusion: Given the isolated adverse events and the impact on the patient survival, performance, and laboratory profile, RFA can be considered safe and efficient in the management of patients with unresectable distal cholangiocarcinomas