Publications by authors named "Andrada Seicean"

71 Publications

Synchronous Pancreatic Tumours: Intraductal Papillary Mucinous Neoplasm with Pancreatic Ductal Adenocarcinoma and Neuroendocrine Tumour: A Case Presentation and Review of Literature.

Chirurgia (Bucur) 2021 Aug;116(eCollection):1-9

Synchronous tumours of the pancreas are rare encounters, with few reported cases. Thus, new information can be brought about the diagnosis, proper management, and prognosis of cases. We believe that the presentation of this case can help to establish relevant conclusions. We report the case of a 54-year-old man, with the preoperative diagnosis of a cephalic intraductal papillary mucinous neoplasm (IPMN), who underwent a planned cephalic pancreatoduodenectomy with completion to total pancreatectomy based on the intraoperative extemporaneous histopathological examination of the resection margin. The final histopathological diagnosis was cephalic IPMN associated with invasive ductal adenocarcinoma (PDAC) and a small well-differentiated neuroendocrine tumour (NET) in the tail of the pancreas. No recurrence was detected in the 3 years of follow-up. We conducted a review of the literature to illustrate the particularities of the presented case; it identified 4 articles about the association of PDAC and NET and 8 articles regarding the association of IPMN with NET. Only 2 patients had a histopathological diagnosis of three synchronous tumours (IPMN, PDAC, and NET). We present a rare case of three synchronous pancreatic tumours, with a favourable evolution after a total pancreatectomy, only two other similar cases being reported in medical literature.
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http://dx.doi.org/10.21614/chirurgia.116.eC.2425DOI Listing
August 2021

Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study.

Endosc Int Open 2021 Aug 16;9(8):E1269-E1275. Epub 2021 Jul 16.

Hospital Clinic de Barcelona - Endoscopy Unit, Barcelona. University of Barcelona, Spain.

 The poor flexibility of large-bore EUS needles often leads to technical failure when sampling from the duodenum. The aim of this study was to evaluate the technical and diagnostic performances of a new Menghini tip 19G nitinol EUS needle for sampling pancreatic solid lesions in the head and uncinate process.  This was a European prospective multicenter single-arm study. A maximum of four passes were allowed. In case of failure, different needles were permitted.  We included 75 patients (51 % males) with lesions in the head (n = 68; 91 %) and uncinate process (n = 7; 9 %) (mean size: 33 ± 12 mm; number of passes: 1.8 ± 0.9). Technical success was seen in 71 of 75 (94.7 %). Diagnostic rates were 89.3 % (67/75) and 94.4 % (67/71) in the intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. In the eight cases with failure, diagnosis was obtained with another needle (n = 4), from another lesion (n = 3) or with follow-up (n = 1). A histological sample was obtained in 64 patients (ITT 85.3 % and PP 90 %) and immunohistochemistry was successfully performed in 13 of 15 lesions in which it was required. No differences between rapid on-site evaluation (ROSE) and non-ROSE groups were observed regarding diagnostic success (87.5 % vs 91 %,  = 0.582) and diagnosis at the first pass (70 % vs 81 %,  = 0.289). Number of passes was lower in the ROSE group (1.4 + 0.9 vs 2.2 + 0.7,  < 0.001). One adverse event was recorded (1.3 %) consisting in a duodenal perforation after a single session EUS-ERCP.  The new nitinol Menghini tip 19G EUS needle showed high technical diagnostic success in safely sampling solid lesions in the head and uncinate process of the pancreas.
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http://dx.doi.org/10.1055/a-1480-0428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8383085PMC
August 2021

Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

Endoscopy 2021 Oct 26;53(10):1071-1087. Epub 2021 Jul 26.

Department of Gastroenterology and Hepatology, University Hospitals Leuven, and TARGID, KU Leuven, Leuven, Belgium.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS. This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1: Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2: Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee's procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3: Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones > 10 mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 300 cases, a native papilla cannulation rate of ≥ 80 % (90 % after a period of mentored independent practice), complete stones clearance of ≥ 85 %, and successful stenting of distal biliary strictures of ≥ 90 % (90 % and 95 % respectively after a mentored period of independent practice). 4: The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥ 90 % of cases, and an FNA/FNB accuracy rate of ≥ 85 %. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.
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http://dx.doi.org/10.1055/a-1537-8999DOI Listing
October 2021

Romanian Guidelines for Nonpharmacological Therapy of IBS.

J Gastrointestin Liver Dis 2021 06 18;30(2):291-306. Epub 2021 Jun 18.

Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca; 2nd Department of Internal Medicine, Cluj-Napoca, Romania.

Background And Aims: The nonpharmacological therapy in irritable bowel syndrome (IBS) is expanding rapidly. Practitioners and medical educators need to be aware of progress and changes in knowledge of this topic. The Romanian Society of Neurogastroenterology aimed to create guidelines based on best evidence on the use of nonpharmacological therapy in IBS.

Methods: A group of experts was constituted. This was divided in eleven subgroups dedicated to eleven categories of nonpharmacological therapy. The subgroups searched the literature and formulated statements and recommendations. These were submitted to vote in order to obtain consensus.

Results: The outcome of this activity is represented by the guidelines of the Romanian Society of Neurogastroenterology, presented in this paper. The recommendations are seen as complementary to the pharmacological therapy and are not intended to recommend avoiding pharmacological drugs.

Conclusions: These guidelines were elaborated by a Delphi process and represent a useful tool for physicians managing patients with IBS.
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http://dx.doi.org/10.15403/jgld-3581DOI Listing
June 2021

Serum levels of soluble programmed death-ligand 1 (sPD-L1): A possible biomarker in predicting post-treatment outcomes in patients with early hepatocellular carcinoma.

Int Immunopharmacol 2021 May 18;94:107467. Epub 2021 Feb 18.

3(rd) Medical Department, "Iuliu Hațieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania; Institute for Gastroenterology and Hepatology, Cluj-Napoca, Romania.

Background: There have been great advances in hepatocellular carcinoma management over the last years. However, there are still no prognostic biomarkers that can identify patients who will benefit the most from curative treatments. We aimed to investigate whether sPD-L1 levels measured before curative treatment is a prognostic biomarker of survival in patients with HCC.

Methods: HCC patients from a prospectively collected database were selected and soluble programmed death-ligand1(sPD-L1) levels were determined. The association of sPD-L1 levels and overall survival (OS) and disease-free survival (DFS) was assessed.

Results: One hundred twenty-one patients with HCC were included. The best cut-off value of sPD-L1 for both DFS and OS was 96 pg/mL. Patients with a high sPD-L1 value (>96 pg/mL) had a shorter disease free survival and OS (hazard ratio 5.42, 95% confidence interval 2.28-12.91, p < 0.001, and hazard ratio 9.67, 95% confidence interval 4.33-21.59, p < 0.001). High sPD-L1 levels were associated with mortality independently from other known survival predictors. We found a positive correlation between sPD-L1 and PD-L1 expression in cancer cells (p = 0.01). In 16 out of 38 patients, sPD-L1 levels decreased from baseline value on week 6 after treatment and in 22 out of 38 patients, sPD-L1 levels increased from the baseline value. However, fluctuations of sPD-L1 in time had no influence on survival (p = 0.148).

Conclusion: We conclude that a high sPD-L1 level is a biomarkerfor a poor outcome in HCC. The predictive value of sPD-L1 levels for a successful anti-PD1/PD-L1 therapy should be investigated in the future.
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http://dx.doi.org/10.1016/j.intimp.2021.107467DOI Listing
May 2021

What is the Impact of the Proportion of Solid Necrotic Content on the Number of Necrosectomies during EUS-Guided Drainage using Lumen-Apposing Metallic Stents of Pancreatic Walled-off Necrosis ?

J Gastrointestin Liver Dis 2020 Dec 12;29(4):623-628. Epub 2020 Dec 12.

Iuliu Hațieganu University of Medicine and Pharmacy Cluj-Napoca; First Surgical Clinic, Cluj-Napoca, Romania.

Background And Aims: The fully-covered, lumen apposing metal stents are designed for one step placement, facilitating the direct endoscopic necrosectomy into the walled-off pancreatic necrosis. However, the prediction of the number of necrosectomy sessions in these patients is not known. This study evaluated the association between the proportion of solid necrotic material inside walled-off necrosis, as assessed during the endosonography placement of a lumen apposing metal stent, and the number of necrosectomies subsequently required.

Methods: Patients from three tertiary medical centers with symptomatic walled off pancreatic necrosis (pain, infection, gastric/biliary obstruction) at more than 4 weeks after onset of acute pancreatitis were retrospectively analysed. Proportion of solid necrotic debris was estimated during endosonography procedure of lumen apposing metal stents placement. Necrosectomy was performed when obstruction or inflammation occurred subsequently. Lumen apposing metal stents were removed after clearance of necrotic content.

Results: In 46 patients with successful lumen apposing metal stents placement, necrosectomy was performed in 39 patients (72.78%). Performance of 3 or more necrosectomies was significantly associated with more than 50% pancreatic necrosis (p=0.032), but not with walled-off pancreatic necrosis size or location. Necrotic infection during lumen apposing metal stents stenting was associated with hypoalbuminemia, but not with necrosectomy requirement. Clinical success after a median follow-up of 13.37 months was 87%.

Conclusions: Walled-off pancreatic necrosis with more than 50% solid necrotic content were associated with more necrosectomy procedures, requiering longer endoscopy time, intravenous sedations, and higher costs.
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http://dx.doi.org/10.15403/jgld-3128DOI Listing
December 2020

Endoscopic ultrasonography-fine needle aspiration of solid pancreatic masses: Do we need the fourth pass? A prospective study.

Diagn Cytopathol 2021 Mar 21;49(3):395-403. Epub 2020 Nov 21.

Department of Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Background: Endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) is important for the differential diagnosis of solid pancreatic lesions. Sample adequacy is related to the number of needle passes, and European guidelines recommend three to four needle passes with a standard EUS-FNA needle. We aimed to evaluate the optimal number of passes with standard EUS-FNA needles in solid pancreatic lesions.

Methods: Patients with solid pancreatic masses without cystic component >20% on computed tomography scan, and without biliary metallic stents, or coagulation problems were included prospectively. Standard 22G needles were used (maximum four passes); each sample was paraffin-embedded and analyzed separately. Final diagnosis was established by EUS-FNA, repeat EUS-FNA, surgery, or follow-up.

Results: Sixty-one of 65 patients were included. The final diagnoses were adenocarcinoma (n = 44, 72%), neuroendocrine tumor (NET) (n = 10, 16%), metastasis (n = 1, 4%) and nonmalignant lesion (n = 6, 10%). Immunohistochemical staining was possible in 17 cases. The diagnosis was established by the first pass in 62% of cases (n = 38), by the second in 15% (n = 9), by the third in 15% (n = 9), and by the fourth in 3% (n = 2). The diagnostic accuracy for all four passes compared to the first three passes was 95% vs 92% (P = .5). The contribution of the fourth pass was not different between adenocarcinoma and NET (2% vs 10%, respectively; P = .667).

Conclusion: Three passes with standard EUS-FNA was optimal for a specific diagnosis of solid pancreatic masses, regardless of the histological type of the lesion.
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http://dx.doi.org/10.1002/dc.24669DOI Listing
March 2021

Risk Factors in Pancreatic Adenocarcinoma: the Interrelation with Familial History and Predictive Role on Survival.

J Gastrointestin Liver Dis 2020 Sep 9;29(3):391-398. Epub 2020 Sep 9.

Department of Gastroenterology, Institute of Gastroenterology and Hepatology, Cluj-Napoca; Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Background And Aims: Pancreatic cancer is associated with poor survival and quality of life. In Romania the prognostic influence of known risk factors for pancreatic adenocarcinoma, such as age, smoking, chronic pancreatitis, diabetes mellitus, and obesity is little known. Their importance in developing cancer in families with a history of adenocarcinoma is less studied. This study aims to assess the risk factors in pancreatic ductal adenocarcinoma, in familial pancreatic adenocarcinoma, in neuroendocrine tumors and to evaluate their predictive role on survival.

Methods: We performed a prospective bicentric study of patients with pancreatic tumors detected in transabdominal imaging; we assessed the risk factors and their possible association with survival.

Results: 312 pancreatic cancer patients (279 with pancreatic ductal adenocarcinoma and 24 patients with neuroendocrine tumors, and nine patients with other malignant types) and 312 controls were included. The median body mass index was significantly higher in patients with neuroendocrine tumors. Positive family history for pancreatic cancer was found in 4% of patients with pancreatic cancer. The risk for familial pancreatic carcinoma was associated with the presence of new-onset diabetes (OR: 4.64, p=0.018). The multivariate logistic analysis suggested that advanced age (OR: 1.67), smoking (OR: 1.67), low body mass index (OR: 12.07), and diabetes (OR: 3.91) were risk factors for pancreatic cancer. The overall survival analysis after adjustment for age and tumor stage showed only advanced tumoral stage (HR=1.6, p=0.003) and metastasis as independent predicting factors (HR=1.67, p<0.001).

Conclusion: Our study suggests that diabetes, smoking, underweight, and age over 60 years are risk factors for pancreatic cancer. Patients with a family history of pancreatic cancer, especially those with new-onset diabetes, should be followed carefully and considered for screening. Only an advanced tumor stage was associated with poor overall survival for patients with pancreatic ductal adenocarcinoma.
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http://dx.doi.org/10.15403/jgld-2529DOI Listing
September 2020

Contrast-enhanced harmonic versus standard endoscopic ultrasound-guided fine-needle aspiration in solid pancreatic lesions: a single-center prospective randomized trial.

Endoscopy 2020 12 10;52(12):1084-1090. Epub 2020 Jul 10.

Gastroenterology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Background: Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) can visualize necrotic areas and vessels inside lesions. CH-EUS findings combined with EUS-guided fine-needle aspiration (EUS-FNA) improves diagnosis in pancreatic solid masses. CH-EUS can also guide EUS-FNA (CH-EUS-FNA), potentially improving the diagnostic rate of EUS-FNA, but such superiority has not been proved in prospective studies. We aimed to assess whether CH-EUS-FNA is superior to standard EUS-FNA for specific diagnosis of solid pancreatic masses and what factors affect the diagnostic rate.

Methods: This randomized controlled study in one tertiary medical academic center included patients with suspected pancreatic solid masses on transabdominal ultrasound or computed tomography (CT) scan. Two passes with a 22-G standard FNA needle were done using EUS-FNA and CH-EUS-FNA in random order, and the visible core obtained was sent for histological analysis. Final diagnosis was based on EUS-FNA or surgical specimen results and on 12-month follow-up by imaging.

Results: 148 patients were evaluated. EUS-FNA and CH-EUS-FNA showed diagnostic sensitivities of 85.5 % and 87.6 %, respectively (not significantly different) and the combined sensitivity of the two passes was 93.8 %. The false-negative rate was not significantly different when hypoenhanced or hyperenhanced lesions were compared with the EUS-FNA results. No differences were seen for the results related to location, size, tumor stage, chronic pancreatitis features, or presence of biliary plastic stent.

Conclusions: The diagnostic rates for samples obtained using 22-G needles with standard EUS-FNA and CH-EUS-FNA were not statistically significantly different.
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http://dx.doi.org/10.1055/a-1193-4954DOI Listing
December 2020

SRED-ARCE Recommendations for Minimally Invasive Interventions During the COVID-19 Pandemic in Romania.

Chirurgia (Bucur) 2020 May-Jun;115(3):289-306

The Romanian Society of Digestive Endoscopy (SRED) and the Romanian Association of Endoscopic Surgery (ARCE) have decided to establish a joint working group to elaborate specific recommendations for organizing the diagnostic and the minimally invasive interventional procedures, in the context of the COVID-19 pandemic. The recommendations are based on the guidelines of the international societies of endoscopy and gastroenterology (ESGE / BSG / ASGE / ACG / AGA), respectively endoscopic surgery (EAES SAGES) (4-8), on the experience of countries severely affected by the pandemic (Italy, France, Spain, USA, Germany, etc.) and they will be applied within the limits of measures imposed at local and governmental level by the competent authorities. On the other hand, these recommendations should have a dynamic evolution, depending on the upward or downward trend of the COVID-19 pandemic at regional and local level, but also according to the findings of professional and academic societies, requiring regular reviews based on the publica tion of further recommendations or international clinical trials. The objectives of the SRED and ARCE recommendations target the endoscopic and laparoscopic surgery activities, to support their non discriminatory used for diagnostic or therapeutic purposes, pursuing the demonstrated benefits of these procedures, in safe conditions for patients and medical staff.
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http://dx.doi.org/10.21614/chirurgia.115.3.289DOI Listing
July 2020

Small molecule drugs in the treatment of inflammatory bowel diseases: which one, when and why? - a systematic review.

Eur J Gastroenterol Hepatol 2020 06;32(6):669-677

Department of Gastroenterology and Hepatology, Iuliu Haţieganu University of Medicine and Pharmacy.

In the 'treat-to-target' era of inflammatory bowel disease (IBD) management, small molecule drugs (SMDs) represent a promising alternative to biomolecular drugs. Moreover, increasing failure rates of anti-tumor necrosis factor α agents have contributed to the development of new molecules with different mechanisms of action and bioavailability. This review focuses on the positioning of new, orally targeted therapies in the treatment algorithm of both Crohn's disease (CD) and ulcerative colitis (UC), with special consideration to their efficacy and safety. We performed a comprehensive search of PubMed and clinical trial registries to identify randomized controlled trials assessing SMDs in adult patients with moderate-to-severe IBD, irrespective of previous exposure to other biologics. In this review, we included 15 double-blind, placebo-controlled trials that assessed the efficacy and safety of Janus kinase inhibitors, sphingosine-1-phosphate modulators (S1P), SMAD blockers, phosphodiesterase 4 inhibitors and α-4 antagonists. The primary endpoints in UC were achieved for tofacitinib in the phase III OCTAVE study and AJM-300, with a favorable safety profile. S1P receptor agonists, such as etrasimod and ozanimod, demonstrated favorable results in induction studies. For CD, filgotinib and upadacitinib also met the primary outcome criteria. Available data have demonstrated so far that SMDs have an advantageous safety and efficacy profile. However, their use in a clinical setting will eventually require a personalized, mechanism-based therapeutic approach.
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http://dx.doi.org/10.1097/MEG.0000000000001730DOI Listing
June 2020

Gastric cancer: adjuvant chemotherapy versus chemoradiation. A clinical point of view.

J BUON 2019 Nov-Dec;24(6):2209-2219

Department of Oncology, "Iuliu Hațieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Gastric cancer represents one of the most severe cancers with poor overall survival. Despite the availability of published data on the efficacy of adjuvant treatment, the actual percentage of treated patients remains low. The toxicity of radiotherapy or chemotherapy regimens differ and clinicians need accessible tools in order to better select candidates for adjuvant treatment. In this review, we present published data from clinical trials and cancer registries that might be useful for properly balancing the efficacy and toxicity of adjuvant treatment in gastric cancer patients who underwent surgery with curative intent.
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June 2020

Relationship between cachexia and perineural invasion in pancreatic adenocarcinoma.

World J Gastrointest Oncol 2019 Dec;11(12):1126-1140

Department of Gastroenterology, Regional Institute of Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400162, Romania.

Background: Cachexia is responsible for the low quality of life in pancreatic adenocarcinoma (PDAC). The rapid disease progression and patient deterioration seems related to perineural invasion, but the relationship between cachexia and perineural invasion for the evolution of the disease has been rarely studied. As perineural invasion is difficult to be highlighted, a biomarker such as the neurotrophic factor Midkine (MK) which promotes the neuronal differentiation and the cell migration could be helpful. Also, Activin (ACV) has been described as cachexia related to PDAC. However, their role for assessing and predicting the disease course in daily practice is not known.

Aim: To assess the relationship between perineural invasion and cachexia and their biomarkers, MK and ACV, respectively, and their prognostic value.

Methods: This study included prospectively enrolled patients with proven adenocarcinoma and a matched group of controls without any malignancies. Patients with other causes of malnutrition were excluded. The plasma levels of ACV and MK were analyzed using western blotting and were correlated with the clinicopathological features and survival data. These results were validated by immunohistochemical analyses of the pancreatic tumor tissue of the patients included in the study and a supplementary group of surgically resected specimens from patients with a benign disease.

Results: The study comprised 114 patients with PDAC, 125 controls and a supplementary group of 14 benign pancreatic tissue samples. ACV and MK were both overexpressed more frequently in the plasma of patients with PDAC than in the controls (63% 32% for ACV, < 0.001; 47% 16% for MK, < 0.001), with similar levels in pancreatic tissue the MK protein expression was closely related to the advanced clinical stage ( = 0.006), the presence of metastasis ( = 0.04), perineural invasion ( = 0.03) and diabetes ( = 0.002), but with no influence on survival. No correlation between clinicopathological factors and ACV expression was noted. Cachexia, present in 19% of patients, was unrelated to ACV or MK level. Higher ACV expression was associated with a shorter survival ( = 0.008).

Conclusion: The MK was a biomarker of perineural invasion, associated with tumor stage and diabetes, but without prognostic value as ACV. Cachexia was unrelated to perineural invasion, ACV level or survival.
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http://dx.doi.org/10.4251/wjgo.v11.i12.1126DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937437PMC
December 2019

Percutaneous Endoscopic Gastrostomy with Jejunal Extension Tube for the Delivery of Levodopa Carbidopa Intestinal Gel: Clinical Practice Guidelines of the Romanian Society of Digestive Endoscopy.

J Gastrointestin Liver Dis 2019 Sep 1;28(3):349-354. Epub 2019 Sep 1.

Regional Institute of Gastroenterology and Hepatology Cluj-Napoca, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.

Percutaneous endoscopic gastrostomy with jejunal extension (PEG/J) was first described in 1998 and has become the standard technique for fixing the tube in place for levodopa carbidopa intestinal gel (LCIG) infusion. The Romanian Society of Digestive Endoscopy (RSDE) decided to create a consensus paper to meet the needs in medical training and practice. After reviewing the available published data and existing recommendations, a consensus process was carried out involving the leaders of opinion in this field. The resulting text and recommendations were approved, after reaching expert consensus, and reflects the views of the RSDE for the best practice of PEG/J tube placement. The pull through method ("pull technique") is the prevailing PEG-tube placement procedure in Romania. The procedure can be performed with intravenous sedation combined with local anesthesia. Although minor complications are common, serious complications are infrequent, and the tube insertion procedures have a good safety record. Redo procedures are sometimes necessary and clinicians should be aware of these situations.
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http://dx.doi.org/10.15403/jgld-404DOI Listing
September 2019

Changes in tumor vascularity depicted by contrast-enhanced EUS as a predictor of prognosis and treatment efficacy in patients with unresectable pancreatic cancer (PEACE): A study protocol.

Endosc Ultrasound 2019 Jul-Aug;8(4):235-240

Carilion Clinic Roanoke, Roanoke, USA.

Patients with unresectable pancreatic cancer have a poor prognosis. The analysis of prognostic factors before treatment may be helpful in determining the best therapeutic strategies. The aim of the PEACE study is to assess the vascularity of pancreatic malignant tumors using contrast-enhanced harmonic EUS (CEH-EUS) and to clarify the prognostic value of tumor vascularity in patients with locally advanced and metastatic pancreatic cancer. Hereby, we present the protocol of a prospective, nonrandomized, single-arm, multicenter study aiming to assess changes in tumor vascularity using CEH-EUS before and 2 months after treatment initiation in patients with unresectable, locally advanced/metastatic pancreatic cancer and to examine the correlation between vascular changes and treatment response, progression-free survival, and overall survival.
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http://dx.doi.org/10.4103/eus.eus_16_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6714481PMC
June 2019

Rescue Therapy of Delayed Gastric Perforation Caused by an External Drainage Using an Over-the-Scope Clip.

J Gastrointestin Liver Dis 2019 Jun 1;28:241-244. Epub 2019 Jun 1.

Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca; First Surgical Clinic, Cluj-Napoca, Romania.

This case reports a iatrogenic gastric fistula due to external draining successfully closed by using an over- the-scope clip. A 50-year old patient with a history of acute pancreatitis, segmental portal hypertension and splenectomy for splenic rupture, with long-term external drainage for a low volume pancreatic fistula, was referred to our hospital. The patient noticed the occurrence of a sudden increase of the drain flow and the immediate drainage of ingested liquid, with no fever or pain. An upper gastrointestinal endoscopy evidenced the gastric fistula with the presence of the drain inside the stomach near a gastric varix. The surgical approach was inappropriate due to bleeding risk. An over-the-scop clip was placed succeeding to stop the gastric flow. The external fistula closed one week later.
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http://dx.doi.org/10.15403/jgld-186DOI Listing
June 2019

CT-guided procedures: an initial experience.

Clujul Med 2018 Oct 30;91(4):427-434. Epub 2018 Oct 30.

Gastrolenterology Department, "Prof Dr Octavian Fodor" Regional Institute of Gastroenterology & Hepatology, Cluj-Napoca, Romania.

Background And Aims: Despite their usefulness, CT-guided procedures have a low profile in Romania. The current study has the purpose of describing a first experience in performing these procedures.

Methods: Tumors and fluid collections that were inaccessible for biopsy or drainage by ultrasound or endoscopic guidance were included. The procedures were performed using a 64-slice GE Optima CT660 CT scanner. The biopsies were carried out using the coaxial technique with an 18 G semiautomatic needle. The drainages were performed using 10 F pig-tail drains that were inserted using the Seldinger technique. Data regarding the size and location of the target lesion, puncture technique, success and complication rates were recorded.

Results: Between May 2017 and April 2018, 30 procedures were performed, of which 26 biopsies and 4 drainage insertions. Of the biopsies 3 were mediastinal, 8 pulmonary, 6 retroperitoneal, 4 pelvic, and 5 of the bone. The drainages were performed for pelvic lymphoceles. The average lesion size was 3.2 cm (0.7-9 cm), with a depth from the skin of 9.1 cm (0.6-15.2 cm). The average procedure duration was 58 minutes (31-93 minutes). A conclusive histopathological diagnosis was set after 92.3% of biopsies. Three procedures resulted in complications, two being minor (hemothorax, soft tissue hematoma) and one severe (tension pneumothorax requiring drainage).

Conclusions: CT guidance offers safe access to lesions that cannot be biopsied or drained under ultrasound or endoscopic guidance.
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http://dx.doi.org/10.15386/cjmed-1145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6296730PMC
October 2018

Pancreatic gangliocytic paraganglioma - CEUS appearance.

J Gastrointestin Liver Dis 2017 12;26(4):336

Iuliu Hațieganu University of Medicine and Pharmacy; Prof. Dr. O.Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.

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http://dx.doi.org/10.15403/jgld.2014.1121.264.cusDOI Listing
December 2017

Role of computer tomography and endoscopic ultrasonography in assessing portal and superior mesenteric vessels invasion in cephalo-pancreatic adenocarcinoma.

Ann Ital Chir 2017 ;88:336-341

Aim: The aim of this study is to evaluate the information given by contrast-enhanced computer tomography (CECT) and ultrasound endoscopy (EUS) regarding vascular involvement of cephalo-pancreatic cancer, data compared with intraoperative findings.

Material And Methods: We choose to analyze the most often interested vessels by tumor development, such as superior mesenteric artery (SMA), superior mesenteric vein (SMV) and portal vein (PV). The patients included in the study (n=425) had a cephalo-pancreatic tumor diagnosed in our Institute and a positive histology for pancreatic adenocarcinoma. The exclusion criteria were: tumors in sites other than the head of the pancreas (including metastases); tumor involvement of common hepatic artery, celiac trunk, inferior cava vein or aorta; CECT or EUS diagnosis performed in another center; and a delay of more than 35 days between the diagnostic imaging and surgery.

Results: In diagnosing SMA invasion CECT had an accuracy of 84,92% and EUS had an accuracy of 87,39%. In diagnosing PV and SMV involvement, CECT had an accuracy of 84,83% and EUS had an accuracy of 92,17%. The accuracy of the two combined examinations in diagnosing vascular invasion was 93%.

Conclusons: Both types of examination have showed good accuracies in diagnosing vascular invasion separately. A combination of the two may be used when the CECT result is uncertain as it provides a higher chance of a correct diagnosis.

Key Words: Pancreatic cancer, Resectability criteria, Vascular invasion.
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July 2018

Infliximab-induced acne and acute localized exanthematous pustulosis: Case report.

Dermatol Ther 2017 Nov 4;30(6). Epub 2017 Oct 4.

Department of Dermatology, Iuliu Haţieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.

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http://dx.doi.org/10.1111/dth.12554DOI Listing
November 2017

Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline - March 2017.

Endoscopy 2017 Oct 12;49(10):989-1006. Epub 2017 Sep 12.

Gedyt Endoscopy Center, Buenos Aires, Argentina.

For routine EUS-guided sampling of solid masses and lymph nodes (LNs) ESGE recommends 25G or 22G needles (high quality evidence, strong recommendation); fine needle aspiration (FNA) and fine needle biopsy (FNB) needles are equally recommended (high quality evidence, strong recommendation).When the primary aim of sampling is to obtain a core tissue specimen, ESGE suggests using 19G FNA or FNB needles or 22G FNB needles (low quality evidence, weak recommendation).ESGE recommends using 10-mL syringe suction for EUS-guided sampling of solid masses and LNs with 25G or 22G FNA needles (high quality evidence, strong recommendation) and other types of needles (low quality evidence, weak recommendation). ESGE suggests neutralizing residual negative pressure in the needle before withdrawing the needle from the target lesion (moderate quality evidence, weak recommendation).ESGE does not recommend for or against using the needle stylet for EUS-guided sampling of solid masses and LNs with FNA needles (high quality evidence, strong recommendation) and suggests using the needle stylet for EUS-guided sampling with FNB needles (low quality evidence, weak recommendation).ESGE suggests fanning the needle throughout the lesion when sampling solid masses and LNs (moderate quality evidence, weak recommendation).ESGE equally recommends EUS-guided sampling with or without on-site cytologic evaluation (moderate quality evidence, strong recommendation). When on-site cytologic evaluation is unavailable, ESGE suggests performance of three to four needle passes with an FNA needle or two to three passes with an FNB needle (low quality evidence, weak recommendation).For diagnostic sampling of pancreatic cystic lesions without a solid component, ESGE suggests emptying the cyst with a single pass of a 22G or 19G needle (low quality evidence, weak recommendation). For pancreatic cystic lesions with a solid component, ESGE suggests sampling of the solid component using the same technique as in the case of other solid lesions (low quality evidence, weak recommendation).ESGE does not recommend antibiotic prophylaxis for EUS-guided sampling of solid masses or LNs (low quality evidence, strong recommendation), and suggests antibiotic prophylaxis with fluoroquinolones or beta-lactam antibiotics for EUS-guided sampling of cystic lesions (low quality evidence, weak recommendation). ESGE suggests that evaluation of tissue obtained by EUS-guided sampling should include histologic preparations (e. g., cell blocks and/or formalin-fixed and paraffin-embedded tissue fragments) and should not be limited to smear cytology (low quality evidence, weak recommendation).
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http://dx.doi.org/10.1055/s-0043-119219DOI Listing
October 2017

Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction?

Endosc Ultrasound 2017 Jan-Feb;6(1):31-36

Internal Medicine and Gastroenterology Clinic, Dr. Carol Davila Central University Emergency Military Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.

The negative predictive value of endoscopic ultrasonography fine-needle aspiration is relatively low. To achieve the improvement of the diagnostic yield, the following were proposed: a higher number of passes, the presence of the rapid on-site cytopathologist evaluation, the fanning technique, or the repetition of the fine needle biopsy. Harmonic contrast-enhanced endosonography may better identify the targeted area in the lesions by avoiding the inside necrosis and the vessels of fibrosis, so it can guide the fine-needle aspiration. Both techniques are complementary, not competitive, and they can be done in the same session. The combined technique is simple, safe, and requires only a few minutes with minimal extra costs compared to standard fine-needle aspiration. It minimally increases the diagnostic rate, and it permits the decrease of the number of passes. However, we will know its real clinical impact only in the future and whether it will be incorporated into the lesion assessment process.
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http://dx.doi.org/10.4103/2303-9027.196917DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331840PMC
February 2017

Maximizing the endosonography: The role of contrast harmonics, elastography and confocal endomicroscopy.

World J Gastroenterol 2017 Jan;23(1):25-41

Andrada Seicean, Ofelia Mosteanu, Regional Institute of Gastroenterology and Hepatology Cluj-Napoca, University of Medicine and Pharmacy "Iuliu Hatieganu", 400162 Cluj-Napoca, Romania.

New technologies in endoscopic ultrasound (EUS) evaluation have been developed because of the need to improve the EUS and EUS-fine needle aspiration (EUS-FNA) diagnostic rate. This paper reviews the principle, indications, main literature results, limitations and future expectations for each of the methods presented. Contrast-enhanced harmonic EUS uses a low mechanical index and highlights slow-flow vascularization. This technique is useful for differentiating solid and cystic pancreatic lesions and assessing biliary neoplasms, submucosal neoplasms and lymph nodes. It is also useful for the discrimination of pancreatic masses based on their qualitative patterns; however, the quantitative assessment needs to be improved. The detection of small solid lesions is better, and the EUS-FNA guidance needs further research. The differentiation of cystic lesions of the pancreas and the identification of the associated malignancy features represent the main indications. Elastography is used to assess tissue hardness based on the measurement of elasticity. Despite its low negative predictive value, elastography might rule out the diagnosis of malignancy for pancreatic masses. Needle confocal laser endomicroscopy offers useful information about cystic lesions of the pancreas and is still under evaluation for use with solid pancreatic lesions of lymph nodes.
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http://dx.doi.org/10.3748/wjg.v23.i1.25DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5221284PMC
January 2017

IL-6 roles - Molecular pathway and clinical implication in pancreatic cancer - A systemic review.

Immunol Lett 2017 01 19;181:45-50. Epub 2016 Nov 19.

Iuliu Hatieganu University of Medicine and Pharmacy, Dept. Of Immunology and Allergology, Cluj-Napoca, Romania; Ion Chiricuta Institute of Oncology, Cluj-Napoca, Romania.

Pancreatic cancer has attracted a great deal of attention owing to the poor outcome, increasing prevalence in the last years and delay diagnosis. Known as a complex disease, it involves genetic mutations, changes in tumour microenvironment and inflammatory component dominated by interleukin-6 and its activated pathways, like Janus Kinase-Signal Transducer and Activator of Translation3, Mitogen Activated Protein Kinase and Androgen receptor. The pro-inflammatory cytokine, plays a central role in oncogenesis, cancer progression, invasiveness, microenvironment changes, treatment resistance, prognosis and associated co morbidities like cachexia and depression. Fulfilling these roles IL-6 requires special attention to understand its complexity in PC development.
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http://dx.doi.org/10.1016/j.imlet.2016.11.010DOI Listing
January 2017

Performance of the Standard 22G Needle for Endoscopic Ultrasound-guided Tissue Core Biopsy in Pancreatic Cancer.

J Gastrointestin Liver Dis 2016 Jun;25(2):213-8

Iuliu Hatieganu University of Medicine and Pharmacy, 1st Surgical Clinic, Cluj-Napoca, Romania.

Background And Aim: Endoscopic ultrasonography (EUS) and EUS-guided fine-needle aspiration (EUS-FNA) are considered good tools for the diagnosis of pancreatic cancer and for obtaining material for cytology or histology. The accuracy of EUS-FNA can rise to 85-95%, but it is lower in cases with a chronic pancreatitis background or with previous biliary stenting. We aimed to establish the diagnostic yield of the visible length of the core biopsy samples in pancreatic cancer by using one single type of standard 22G needle and to evaluate the factors which can influence the results.

Method: EUS-FNA was performed by using a 22G standard needle on patients prospectively recruited with the suspicion of pancreatic masses on transabdominal ultrasound or CT scan over a period of eight months. The number of passes was limited by the length of the core obtained. The final diagnosis was based on EUS-FNA or hepatic biopsy for their metastasis or by follow up every three month by imaging methods.

Results: The study included 118 patients. Previous stents were present in 10 patients and chronic pancreatitis features were found in 3 patients. The procedure sensitivity was 89% and the global accuracy was 89%. The presence of biliary stents did not impede the accuracy of results. The number of passes did not influence the results.

Conclusions: The diagnostic rate of core biopsy by using 22G needles had a high accuracy and it is safe when the length of core dictates the number of passes. The presence of biliary stents did not influence the results.
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http://dx.doi.org/10.15403/jgld.2014.1121.252.uggDOI Listing
June 2016

Results of third-generation epirubicin/cisplatin/xeloda adjuvant chemotherapy in patients with radically resected gastric cancer.

J BUON 2016 Mar-Apr;21(2):349-59

Prof. Dr. Ion Chiricuta" Institute of Oncology, Department of Medical Oncology, Cluj-Napoca, Romania.

Purpose: The purpose of this study was to evaluate the efficacy and toxicity of a third-generation chemotherapy regimen in the adjuvant setting to radically operated patients with gastric cancer. This proposed new adjuvant regimen was also compared with a consecutive retrospective cohort of patients treated with the classic McDonald regimen.

Methods: Starting in 2006, a non-randomized prospective phase II study was conducted at the Institute of Oncology of Cluj-Napoca on 40 patients with stage IB-IV radically resected gastric adenocarcinoma. These patients were administered a chemotherapy regimen already considered to be standard treatment in the metastatic setting: ECX (epirubicin, cisplatin, xeloda) and were compared to a retrospective control group consisting of 54 patients, treated between 2001 and 2006 according to McDonald's trial.

Results: In a previous paper, we reported toxicities and the possible predictive factors for these toxicities; in the present article, we report on the results concerning predictive factors on overall survival (OS) and disease free survival (DFS). The proposed ECX treatment was not less effective than the standard suggested by McDonald's trial. Age was an independent prognostic factor in multivariate analysis. N3 stage was an independent prognostic factor for OS and DFS. N ratio >70% was an independent predictive factor for OS and locoregional disease control. The resection margins were independent prognostic factors for OS and DFS.

Conclusion: The proposed treatment is not less effective compared with the McDonald's trial. Age was an independent prognostic factor in multivariate analysis. N3 stage represented an independent prognostic factor and N ratio >70% was a predictive factor for OS and DFS. The resection margins were proven to be independent prognostic factors for OS and DFS.
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July 2016

Non-Invasive Assessment of Inflammation and Treatment Response in Patients with Crohn's Disease and Ulcerative Colitis using Contrast-Enhanced Ultrasonography Quantification.

J Gastrointestin Liver Dis 2015 Dec;24(4):457-65

University of Medicine and Pharmacy Iuliu Hatieganu, and Regional Institute of Gastroenterology and Hepatology Prof. Dr. Octavian Fodor, Cluj-Napoca, Romania.

Background And Aim: Novel biological therapies in Crohn's disease (CD) or Ulcerative colitis (UC) require a proper follow-up for the assessment of bowel inflammation. While endoscopy is the standard method, the imaging techniques using contrast, particularly contrast enhanced ultrasonography (CEUS), are better tolerated by the patients and can be used more frequently. Our aim was to find the usefulness of dynamic CEUS quantification as compared to endoscopy in the assessment of disease activity and in the follow-up under therapy of the patients suffering from either CD or UC.

Method: We have prospectively evaluated 67 patients with UC and 46 with CD, diagnosed by ileo-colonoscopy and biopsy, comparing the endoscopic scores with clinical scores, C reactive protein (CRP), intestinal wall thickness, layer scores after CEUS and TIC parameters (using SonoLiver® software - Imax, RT, TTP, mTT and AUC). For 25 patients with UC and 13 with CD we performed comparisons of the parameters before and after 3 months of treatment and correlated them with the changes in the endoscopic scores.

Results: For UC, time-intensity curves (TIC) volume parameters (AUC) correlated better with endoscopy (ρ=0.64) than the clinical score (ρ =0.62). Other parameters such as CRP and thickness showed significant but less strong correlation, while TIC flow parameters (RT, TTP and mTT) did not show a significant correlation. Results were similar for CD (ρ=0.64 for Imax vs ρ=0.58 for CDAI). The best predictor for endoscopic improvement in both UC and CD was ln(AUC), with a Wilcoxon Z score of 3.76 and 2.61, respectively. There was also a good correlation between the difference of its values and the difference in endoscopic scores before and after the treatment (rho is 0.68 in UC and 0.73 in CD).
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http://dx.doi.org/10.15403/jgld.2014.1121.244.chrDOI Listing
December 2015

Harmonic Contrast-Enhanced Endoscopic Ultrasonography for the Guidance of Fine-Needle Aspiration in Solid Pancreatic Masses.

Ultraschall Med 2017 Apr 14;38(2):174-182. Epub 2015 Aug 14.

First Surgical Clinic, University of Medicine and Pharmacy Cluj-Napoca, Romania.

 The global accuracy of fine-needle aspiration guided by endoscopic ultrasound (EUS-FNA) for pancreatic adenocarcinoma is about 85 %. The use of contrast agents during EUS to highlight vessels and the necrotic parts of pancreatic masses may improve biopsy guidance. Our aim was to assess whether the guidance of FNA by harmonic contrast-enhanced endoscopic ultrasound (CH-EUS) would increase diagnostic accuracy relative to conventional EUS-FNA in the same pancreatic masses.  In a prospective study, EUS-FNA was performed in patients with pancreatic masses on CT scan, followed by harmonic CH-EUS using SonoVue. A second cluster of CH-EUS-FNA was performed on contrast-enhanced images. The final diagnosis was based on the results of EUS-FNA and surgery, or the findings after 12 months' follow-up.  The final diagnosis was adenocarcinoma (n = 35), chronic pancreatitis (n = 10), or other (n = 6). The diagnostic accuracy based on core histology was 78.4 % for EUS-FNA and 86.5 % for CH-EUS-FNA (p = 0.35). The accuracy increased to 94 % when the two methods' results were combined. The two false-negative EUS-FNA cases were correctly appreciated by CH-EUS. Neither core histology size nor the presence of necrosis was significant for the true-positive diagnosis of malignancy.  CH-EUS-FNA had an insignificant incremental effect on diagnostic accuracy compared with conventional EUS-FNA in our small group. The presence of necrosis did not influence the results of CEUS-FNA. Qualitative assessment of the contrast uptake within the lesion was useful in false-negative EUS-FNA cases.
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http://dx.doi.org/10.1055/s-0035-1553496DOI Listing
April 2017

New targeted therapies in pancreatic cancer.

World J Gastroenterol 2015 May;21(20):6127-45

Andrada Seicean, Livia Petrusel, Regional Institute of Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 4000192, Romania.

Patients with pancreatic cancer have a poor prognosis with a median survival of 4-6 mo and a 5-year survival of less than 5%. Despite therapy with gemcitabine, patient survival does not exceed 6 mo, likely due to natural resistance to gemcitabine. Therefore, it is hoped that more favorable results can be obtained by using guided immunotherapy against molecular targets. This review summarizes the new leading targeted therapies in pancreatic cancers, focusing on passive and specific immunotherapies. Passive immunotherapy may have a role for treatment in combination with radiochemotherapy, which otherwise destroys the immune system along with tumor cells. It includes mainly therapies targeting against kinases, including epidermal growth factor receptor, Ras/Raf/mitogen-activated protein kinase cascade, human epidermal growth factor receptor 2, insulin growth factor-1 receptor, phosphoinositide 3-kinase/Akt/mTOR and hepatocyte growth factor receptor. Therapies against DNA repair genes, histone deacetylases, microRNA, and pancreatic tumor tissue stromal elements (stromal extracellular matric and stromal pathways) are also discussed. Specific immunotherapies, such as vaccines (whole cell recombinant, peptide, and dendritic cell vaccines), adoptive cell therapy and immunotherapy targeting tumor stem cells, have the role of activating antitumor immune responses. In the future, treatments will likely include personalized medicine, tailored for numerous molecular therapeutic targets of multiple pathogenetic pathways.
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http://dx.doi.org/10.3748/wjg.v21.i20.6127DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445091PMC
May 2015

Romanian guidelines on the diagnosis and treatment of exocrine pancreatic insufficiency.

J Gastrointestin Liver Dis 2015 Mar;24(1):117-23

Carol Davila University of Medicine and Pharmacy; Fundeni Clinical Institute, Bucharest, Romania.

In assessing exocrine pancreatic insufficiency (EPI), its diverse etiologies and the heterogeneous population affected should be considered. Diagnosing this condition remains a challenge in clinical practice especially for mild-to-moderate EPI, with the support of the time-consuming breath test or the coefficient of fat absorption. The fecal elastase-1 test, less precise for the diagnosis, cannot be useful for assessing treatment efficacy. Pancreatic enzyme replacement therapy (PERT) is the mainstay of treatment, whereby enteric-coated mini-microspheres are taken with every meal, in progressive doses based on an individual's weight and clinical symptoms. The main indication for PERT is chronic pancreatitis, in patients who have clinically relevant steatorrhea, abnormal pancreatic function test or abnormal function tests associated with symptoms of malabsorption such as weight loss or meteorism. While enzyme replacement therapy is not recommended in the initial stages of acute pancreatitis, pancreatic exocrine function should be monitored for at least 6-18 months. In the case of unresectable pancreatic cancer, replacement enzyme therapy helps to maintain weight and improve overall quality of life. It is also indicated in patients with celiac disease, who have chronic diarrhea (in spite of gluten-free diet), and in patients with cystic fibrosis with proven EPI.
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http://dx.doi.org/10.15403/jgld.2014.1121.appDOI Listing
March 2015
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