Autoimmune Pancreatitis Type 1 with Biliary, Nasal, Testicular, and Pulmonary Involvement: A Case Report and a Systematic Review.

INTRODUCTION: Immunoglobulin G4-related disease (IgG4-RD) is an immune-mediated condition associated with fibroinflammatory lesions that can occur at almost any anatomical site. It often presents as a multiorgan disease that may mimic malignancy, infection, or other immune-mediated conditions. Autoimmune pancreatitis (AIP) type 1 is the most prominent manifestation of IgG4-RD in the digestive tract, with common extra-pancreatic inflammation. We present the first patient with AIP and involvement of the testicles and nasal cavity. PATIENT AND METHODS: A case of a patient with AIP type 1 and other organ involvement (bile ducts, testicles, nasal polyps, and lungs) is described. Additionally, a systematic review of AIP type 1 with testicular and nasal involvement was conducted. RESULTS: The systematic review found two cases of AIP type 1 with testicular involvement and 143 cases with AIP type 1 with nasal cavity involvement. None of them had both testicular and nasal involvement. CONCLUSIONS: This is the first case of AIP type 1 with other organ involvement, including testicular and nasal involvement, to be described. The number of patients with nasal and testicular involvement described in the literature is low. Creating awareness of this rare clinical condition is necessary, especially due to the very effective available treatment with corticosteroids and rituximab.

Unraveling the relationship between autoimmune pancreatitis type 2 and inflammatory bowel disease: Results from two centers and systematic review of the literature.

INTRODUCTION: The relationship between autoimmune pancreatitis (AIP) type 2 and inflammatory bowel disease (IBD) has been established and previously described within International Consensus Diagnostic Criteria. However, it is unknown if the presence of IBD changes the natural disease course of AIP type 2. Our aim was to investigate the association between AIP type 2 and IBD as well as to systematically summarize all the existing evidence in the literature. METHODS: Electronic medical record analysis was conducted in two centers (in Stockholm, Sweden, and Milan, Italy; records dated between January 2001 and June 2021). Additionally, we conducted a systematic review of the literature. RESULTS: A total of 35 patients (18 females, 51.4%) fulfilled the diagnostic criteria of AIP type 2 and were included in the study. A diagnosis of IBD was established in 29 patients (82.8%), ulcerative colitis in 17 (58.6%) and Crohn's disease in 11 (37.9%). Median follow-up was 54 months. AIP patients with IBD commonly presented with abdominal pain and/or acute pancreatitis at diagnosis, the latter was prevailing in concomitant and later IBD onset. These patients more frequently used steroids, but there were no differences in relapse rates. Concomitant onset of IBD was associated with the development of diabetes mellitus. There were no cases of colon or pancreatic malignancy during follow-up. In our systematic analysis, a total of 693 AIP type 2 patients were included from 24 single-center retrospective studies and 8 multicenter retrospective studies. A diagnosis of IBD was reported in 330 (47.8%) patients. Relapse rate was 20.0%. CONCLUSIONS: Clinical and radiological remission of AIP type 2 was high, while the cumulative incidence of relapse is around 20%. Our results show that concomitance of IBD imposes no obvious risk of a different disease course for AIP type 2.

Impact of biliary stenting in endoscopic ultrasound-guided tissue acquisition among patients with pancreatic cancer.

INTRODUCTION: Pancreatic malignancies represent highly fatal diseases with poor prognosis and constantly increasing incidence despite modern diagnostic and therapeutic options. Both endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) are regarded as mainstays in pancreatic cancer management. The present study aims to evaluate whether accuracy EUS with fine-needle aspiration or biopsy (FNA or FNB) in pancreatic cancer diagnosis is influenced by prior biliary stenting or by technical or anatomical features (stent type, number of needle passes, common bile duct or Wirsung's diameter, topographical characteristics and diameter of the pancreatic tumor). MATERIALS AND METHODS: This retrospective study includes 243 patients with pancreatic cancer who underwent ERCP and EUS with fine-needle aspiration or biopsy (FNA or FNB). RESULTS AND DISCUSSION: Out of the total number of patients, 68 were stented prior to EUS. We found that the EUS-FNA diagnostic yield is not influenced either by the presence of biliary stent, nor by the type of stent (plastic or metallic). Moreover, the mean needle passes required were similar for both stented patients and not stented ones. CONCLUSIONS: Ultimately, given our results, we can state that EUS-FNA/FNB can be safely and accurately performed in the presence of biliary stents.

Efficacy and Safety of a Novel Triple-anchoring Technique for Colonic Hybrid Endoscopic Mucosal Resection: A Case Series.

BACKGROUND AND AIMS: A hybrid technique may be a reasonable compromise to make endoscopic mucosal resection (EMR) more reliable for lesions ≥ 20 mm and a good way of approaching to endoscopic submucosal dissection (ESD). The aim of this study was to assess the efficacy and safety of a novel hybrid EMR technique, triple-anchoring EMR (T-EMR) for colorectal lesions 20-30 mm. METHODS: Fifteen patients have been prospectively enrolled to T-EMR from December 2019 to April 2020 in two Endoscopy Units: Policlinico A. Gemelli, Rome, and University Hospital of Udine, Italy. Patients eligible for the study were ≥18 years old with superficial colorectal lesions 20-30 mm, morphologically liable to endoscopic treatment based on chromoendoscopy. The primary endpoint was assessment of the "en bloc" and the free resection margins (R0) rates. The secondary endpoints were resected specimen size, procedure time, complication rate, and recurrence rate at 6 months. RESULTS: Among the 15 patients enrolled, 12 were males (80%), mean age 68.73±11.04 years. The mean size of the lesions was 24.93±2.89 mm. Mean procedure time was 22.13±4.31 min. T-EMR was performed en bloc in 14/15 patients (93.3%) with R0 in 13/15 patients (86.7%). No major intra-/peri-procedural or delayed complications occurred. At histological analysis, 13/15 lesions (86.7%) were adenomas, while 2 were early colorectal cancer. At a 6-month follow-up colonoscopy, only one patient (6.7%) had a recurrence of adenoma. CONCLUSIONS: T-EMR seems to be an effective and safe option to treat colorectal lesions between 20 and 30 mm, with a short procedure time and low costs.

Efficacy and safety of rituximab in autoimmune pancreatitis type 1: our experiences and systematic review of the literature.

INTRODUCTION: Autoimmune pancreatitis (AIP) is a special form of pancreatitis that responds well to glucocorticoid (GC) treatment. Relapses of AIP are common. The anti-CD20 antibody rituximab (RTX) has shown promising results in GC refractory cases, but long-term data are scarce. The study aims to determine the clinical and imaging response to RTX and summarize the existing data on RTX therapy in patients with AIP type 1 in the literature. PATIENTS AND METHODS: Retrospective analysis of electronic medical records was conducted. Additionally, we conducted a systematic review of the literature concerning RTX use in AIP type 1. RESULTS: Twelve (11.7%) of 103 patients with AIP type 1 were treated with RTX during the study period: eight (66.7%) achieved complete and four (33.3%) partial remission. RTX was discontinued in one patient who developed fever and reactivation of latent tuberculosis. None of the remaining 11 patients relapsed during a median follow-up of 17 months. No significant differences were detected in baseline clinical characteristics or history of relapse between the patients who obtained complete and partial remission. Altogether, eight studies with 110 AIP type-1 patients treated with RTX were analyzed. Adverse effects ranged from 11-43% and the relapse-free period during follow-up (range 2-173 months) ranged from 38-94%. CONCLUSIONS: Our results confirm that RTX is efficacious in the treatment of AIP type 1 by inducing remission and preventing relapse. In addition, there are few adverse effects of the treatment.

Risk of Developing Pancreatic Cancer in Patients with Chronic Pancreatitis.

Background: Patients with chronic pancreatitis (CP) have an increased risk of developing pancreatic ductal adenocarcinoma (PDAC). We present data on PDAC in one of the most extensive European single-centre cohort studies of patients with CP. Methods: Retrospective analysis of prospectively collected data of patients with CP was performed. Aetiology of CP was determined according to the M-ANNHEIM classification system and only patients with definite CP > 18 years at data analysis were included. The final dataset included 581 patients with definite CP diagnosed between 2003 and 2018. Results: At CP diagnosis, there were 371 (63.9%) males and 210 (36.1%) females (median age 57 years, range 2-86). During 3423 person-years of observation, six pancreatic cancers were diagnosed (0.2% year). The mean time between diagnosis of CP and the occurrence of PDAC was 5.0 years (range 2.7-8.6). None of the cancer patients had a family history of PDAC. Diabetes mellitus (DM) was present in five of six (83.3%) patients with PDAC: in three patients before and in two after CP diagnosis. Clinical/laboratory signs of pancreatic exocrine insufficiency (PEI) were present in five of six (83.3%) patients with PDAC: in two at diagnosis of CP and in three after diagnosis. The mean survival time was 4 months after the diagnosis of PDAC (range 0.5-13). PDAC occurred significantly more often (p < 0.001) in two groups of patients without previous acute pancreatitis (AP): 2 of 20 patients (10%) with low body mass index (BMI) and PEI and in 3 of 10 (30%) patients with high BMI and DM at diagnosis of CP. Conclusions: Patients with CP have a high risk of developing PDAC, although risk is low in absolute terms. Our data suggest the possibility of defining subgroups of patients with a particularly elevated risk of PDAC. Such a possibility would open a path to personalised decision making on initiation of PDAC surveillance of patients with no previous episode of AP, (i) with low BMI and PEI, or (ii) elevated BMI and DM.

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.

Pancreatitis Associated with Viral Hepatitis: Systematic Review.

BACKGROUND: We conducted a systematic review in order to summarize the available data on pancreatitis associated with viral hepatitis. METHODS: A comprehensive literature search of Medline, Scopus and ISI Web of Science databases was conducted and papers eligible for the inclusion identified. RESULTS: In total, 46 studies reporting data on 73 patients were included in the analysis. Most of the cases were diagnosed in Asia (57.53%), followed by North America (23.29%), and Europe (13.70%). Most of the patients were affected by hepatitis A virus (HAV) (42.47%), followed by hepatitis E virus (HEV) (28.77%), hepatitis B virus (HBV) (8.22%), and hepatitis C virus (HCV) (1.37%), while 17.81% at the time of diagnosis were classified as affected by "hepatitis virus". Pancreatitis was severe in 32.88% of cases. The respiratory system was affected in 2.74% of patients, 6.85% experienced renal failure, while 5.48% experienced a multiorgan dysfunction syndrome (MODS). Four patients (5.48%) needed pancreatic surgery. Despite the treatment, 21.92% of patients died. We identified fulminant hepatitis (p < 0.0001), MODS (p < 0.0001) and severe pancreatitis (p < 0.0001) to be significantly more present in patients who died in comparison to cured ones. CONCLUSION: Increased awareness of pancreatic involvement in viral hepatitis is needed because it can have a substantial impact on therapeutic approaches and outcomes.

Pancreatic exocrine insufficiency and pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer: A systematic review and meta-analysis.

BACKGROUND: Pancreatic cancer is the fourth leading cause of cancer mortality. Most patients are diagnosed with advanced pancreatic cancer, either at locally advanced or metastatic stages, and have a high rate of malnutrition and weight loss which are associated with poor outcomes. Pancreatic exocrine insufficiency is one of the causes of malnutrition and weight loss in these patients. The prevalence and clinical consequences of pancreatic exocrine insufficiency in advanced pancreatic cancer are poorly investigated with heterogeneous results. We sought to determine the prevalence and clinical consequences of pancreatic exocrine insufficiency and the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer by systematic review and meta-analysis. METHODS: Scopus, Medline, and Embase were searched for cohort studies or randomised clinical trials reporting pancreatic exocrine insufficiency and/or the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer. We considered pancreatic exocrine insufficiency as an abnormal result on direct and/or indirect pancreatic exocrine function tests. Pancreatic enzyme replacement therapy was evaluated by its effect on survival and quality of life in patients with advanced pancreatic cancer. RESULTS: A total of 11 studies were included; seven studies reported the prevalence of pancreatic exocrine insufficiency and seven the effect of pancreatic enzyme replacement therapy in advanced pancreatic cancer. The pooled prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer was 72% (95% confidence interval: 55-86%), being significantly higher when tumours were located in the pancreatic head (relative risk = 3.36, 1.07-10.54; p = 0.04) six studies investigated the impact of pancreatic enzyme replacement therapy on survival/quality of life. Pancreatic enzyme replacement therapy was associated with 3.8 months (95% confidence interval: 1.37-6.19) survival benefit. Patients receiving pancreatic enzyme replacement therapy had a trend towards a better quality of life.Conclusions The prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer is substantial and its treatment can improve the outcomes of these patients.

Pancreatic tuberculosis: A systematic review of symptoms, diagnosis and treatment.

INTRODUCTION: Although pancreatic tuberculosis (TB) is traditionally considered to be a rare clinical entity, in recent times, an increase in the number of reports of pancreatic TB has been noted. We conducted a systematic review in order to summarise currently available data on pancreatic TB. METHODS: A comprehensive literature search of Medline, Scopus and ISI Web of Science databases was conducted in order to identify papers reporting cases of pancreatic TB. The eligibility criteria for inclusion in the review required that the studies reported patient(s) affected by pancreatic TB and that individual data on age, sex, clinical presentation and outcome were available. RESULTS: In total, 116 studies reporting data on 166 patients were included in the analysis. The majority of patients were males (62.1%) diagnosed at a mean age of 41.61 ± 13.95 years. Most cases were diagnosed in Asia (50.0%), followed by North America (22.9%), Europe (20.5%), Africa (4.2%) and South America (2.4%). Human immunodeficiency virus (HIV) infection was diagnosed in 25.3% of those affected. Pancreatic TB most frequently presented itself in the form of a pancreatic mass (79.5%) localised mainly in the head (59.0%) and less frequently in the body (18.2%) and tail (13.4%). Extrapancreatic TB involvement most frequently affected the peripancreatic lymph nodes (47.3%). More than half of patients (55.2%) were subjected to laparotomy, while 21.08% underwent endoscopic ultrasound fine-needle aspiration biopsy. The presence of TB was identified most frequently through histological analysis (59.6%), followed by culture (28.9%), staining (27.7%) and, in a smaller number, by polymerase chain reaction (9.6%) and cytology (6.6%). Almost all patients received anti-tubercular pharmacological therapy (98.2%), while 24.1% underwent surgery. Despite treatment, 8.7% of patients died. CONCLUSION: Increased awareness of pancreatic TB is needed, not only in endemic areas but especially in relation to HIV infection and other clinical conditions associated with immunoincompetence.

An Overview on Primary Sclerosing Cholangitis.

Primary sclerosing cholangitis is a progressive liver disease characterized by chronic inflammation leading to liver fibrosis and cirrhosis. Even though the exact pathogenesis is still unclear, a combination of autoimmune, environmental, and ischemic factors could explain certain aspects of the disease. The most important diagnostic step is cholangiography, which can be obtained either by endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiography (MRCP as the gold standard), or percutaneous transhepatic cholangiography. It shows multifocal short biliary duct strictures leading to the "beaded" aspect. Cholangiocarcinoma and colorectal adenocarcinoma are the most feared complications in patients with Primary sclerosing cholangitis (PSC). Continuous screening consists of annual clinical, biochemical, and ultrasound assessments in asymptomatic patients and annual colonoscopy in patients with PSC and inflammatory bowel disease. In newly diagnosed patients with PSC, colonoscopy is mandatory and, if negative, then, a repeat colonoscopy should be performed in 3-5 years. The lack of efficient curative medical treatment makes invasive treatments such as liver transplant and endoscopy the mainstream for managing PSC and its complications. Until now, even though only ursodeoxycholic acid has shown a moderate clinical, biochemical, and even histological improvement, it has no significant influence on the risk of cholangiocarcinoma, liver transplant need, or death risk and it is no longer recommended in treating early PSC. Further studies are in progress to establish the effect of molecular-targeted therapies in PSC.

The Impact of Dietician Support and Behavioural Therapy in Addition to Concomitant Treatment with Intragastric Balloon in Obese Patients.

INTRODUCTION AND AIMS: Patients treated with intragastric balloon (IGB) may benefit from treatment and follow-up by a multidisciplinary team, where the dietician is considered the only essential professional besides the endoscopist. The aim of this study is to evaluate the impact of dietician support and behavioral therapy in terms of weight loss in patients concomitantly treated with IGB while the device is in situ. METHODS: Patients with IGB in situ, in period 2005-2018, were invited to undergo a dietician check-up (DC) every 1.5 months, accompanied by cognitive behavioral therapy. Considering their attendance at the dietician check-ups (DCs), patients were categorized as non-compliant (0 DC), partially compliant (1-2 DCs), and highly compliant (≥ 3 DCs). A comparison was made among the three groups regarding % of total body weight loss (%TBWL) and ΔBMI at 180 ± 15 days when the IGB was in situ. RESULTS: One hundred eighty-three obese patients treated with fluid-filled IGB were included. Body weight data at 180 ± 15 days during the IGB in situ, as well as attendance at the DCs, were available for 170 out of 183 patients. There was no difference among compliant, partially compliant, and non-compliant patients to DCs regarding %TBWL at 180 ± 15 days (p = 0.17). However, non-compliant patients had a higher ΔBMI at 180 ± 15 days in comparison to those compliant or partially compliant to DCs (p = 0.03). CONCLUSION: Despite its undisputed educational role, attendance at DCs does not seem to correlate with an additional weight loss while the IGB is in situ.

Prevalence of Extrapancreatic Malignancies Among Patients With Intraductal Papillary Mucinous Neoplasms of the Pancreas.

OBJECTIVES: We conducted a study in order to assess the prevalence of extrapancreatic malignancies (EPMs) in a cohort of patients with intraductal papillary mucinous neoplasms (IPMNs) from northeastern Italy. METHODS: A study was conducted in hospital Santa Maria della Misericordia, Udine, Italy. Hospital records were screened in order to identify newly diagnosed IPMN cases in the period from January 1, 2009, to December 31, 2015. We searched for EPMs diagnosed previous to, synchronous to, or after the IPMN. The ratio of the observed (O) number of patients with EPMs to the expected (E) was calculated. RESULTS: We identified 72 EPMs in 63 (31.8%) of 198 patients included. Among them, 51 (70.8%) were diagnosed previous to, 17 (23.6%) synchronous to, and 4 (5.6%) after the IPMN. Most frequently diagnosed were colorectal (12 patients [6.1%]), breast (8 patients [6.8%, in females]), renal cell (8 patients [4.0%]), and prostate cancer (7 patients [8.6%, in males]). The O/E ratios for EPMs were significantly increased for cancer in general (3.66; 95% confidence interval [CI], 2.39-5.37), renal cell (9.62; 95% CI, 1.98-28.10), prostate (4.91; 95% CI, 1.59-11.45), and breast cancer (3.16; 95% CI, 1.03-7.37). CONCLUSIONS: We report an increased risk of EPMs in patients with IPMN, especially for renal cell, prostate, colorectal, and breast cancer.

Which Lynch syndrome screening programs could be implemented in the "real world"? A systematic review of economic evaluations.

PURPOSE: Lynch syndrome (LS) screening can significantly reduce cancer morbidity and mortality in mutation carriers. Our aim was to identify cost-effective LS screening programs that can be implemented in the "real world." METHODS: We performed a systematic review of full economic evaluations of genetic screening for LS in different target populations; health outcomes were estimated in life-years gained or quality-adjusted life-years. RESULTS: Overall, 20 studies were included in the systematic review. Based on the study populations, we identified six categories of LS screening program: colorectal cancer (CRC)-based, endometrial cancer-based, general population-based, LS family registry-based, cascade testing-based, and genetics clinic-based screening programs. We performed an in-depth analysis of CRC-based LS programs, classifying them into three additional subcategories: universal, age-targeted, and selective. In five studies, universal programs based on immunohistochemistry, either alone or in combination with the BRAF test, were cost-effective compared with no screening, while in two studies age-targeted programs with a cutoff of 70 years were cost-effective when compared with age-targeted programs with lower age thresholds. CONCLUSION: Universal or <70 years-age-targeted CRC-based LS screening programs are cost-effective and should be implemented in the "real world."

Carotenoid intake from natural sources and colorectal cancer: a systematic review and meta-analysis of epidemiological studies.

Carotenoid intake from natural sources has been hypothesized to reduce the risk of colorectal cancer (CRC). The aim of this study was to systematically review the epidemiological evidence for the association between carotenoid intake from natural sources and CRC development. We carried out a systematic review and meta-analysis of epidemiological studies to investigate whether the intake of specific carotenoids from natural sources, as well as combined carotenoids, is associated with the risk of CRC overall and by anatomic subsite. A comprehensive literature search of MEDLINE and Scopus databases was performed. Twenty-two articles were identified from the literature search, of which 16 were case-control studies and 6 were cohort studies. In the random-effects meta-analysis of case-control and cohort studies, we found no association between the intake of individual and total carotenoids and the risk of CRC overall and by anatomic subsite. Overall, our findings do not support a significant association between intake of specific carotenoids from dietary sources, as well as combined carotenoids, and the risk of CRC overall and by anatomic subsite.

Association between Mediterranean diet and head and neck cancer: results of a large case-control study in Italy.

The Mediterranean diet (MD) is a known protective factor for head and neck cancer (HNC); however, there is still a lack of studies investigating this association by HNC subsite. The aim of the present study was therefore to evaluate the association between adherence to MD and HNC overall and by cancer subsite, as well as the effect of the individual food components on HNC risk. A case-control study was carried out at the Gemelli Hospital of Rome (Italy). A total of 500 HNC cases and 433 controls were interviewed. Dietary intake was assessed through a validated food frequency questionnaire that collected information on over 25 food items. Odds ratios (ORs) and 95% confidence intervals (CI) of HNC were calculated using a multiple logistic regression model. We found a reduced risk of both oral cavity and pharynx cancer (OR=0.61; CI: 0.54-0.70) and larynx cancer (OR=0.64; CI: 0.56-0.73) with increasing adherence to MD. We also found a high consumption of fruit, vegetables, and legumes to be significantly associated with a lower risk of larynx as well as oral cavity and pharynx cancers. Our study showed that adherence to MD acts protectively against HNC overall and by cancer subsite.

Single Nucleotide Polymorphisms within the 8Q24 Region are Not Associated with the Risk of Intraductal Papillary Mucinous Neoplasms of the Pancreas.

BACKGROUND AND AIMS: Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas have been reported to be associated with an increased risk of developing extra-pancreatic malignancies. A common genetic background has been hypothesised to be responsible for such an association. Human chromosomal region 8q24 has been associated with many types of cancer. The majority of these associations lie at approximately 128 Mb on chromosome 8. We conducted a study in order to examine the association between IPMN and single nucleotide polymorphisms (SNPs) from the 8q24 region, namely rs10505477, rs6983267, rs7014346, rs6993464, previously reported to influence general cancer susceptibility. METHODS: The study was performed on 117 IPMN cases and 231 controls. Cases were enrolled at the Digestive Endoscopy Unit, Policlinico Agostino Gemelli from January, 2010 to June, 2011, with either a prevalent or incident IPMN diagnosis. Status of SNPs was determined using a StepOne Real-time PCR system (Applied Biosystems) and TaqMan SNP Genotyping Assay™ 40X. Unconditional multiple logistic regression models were used to estimate odds ratios and 95% confidence intervals for the association of selected SNPs and IPMNs. RESULTS: Cases were more likely to report a 1st degree family history of cancer (p<0.001), as well as heavy smoking (p=0.001) and heavy drinking habits (p<0.001). No significant association was observed between IPMN and selected SNPs. The results were confirmed also when stratified according to any 1st-degree family history of cancer. CONCLUSION: Patients with IPMN do not have a higher prevalence of SNPs in the human chromosomal region 8q24 in respect to the control population.

Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

OBJECTIVE: The study aims to assess the status of registration of observational studies. STUDY DESIGN AND SETTING: We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. RESULTS: One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. CONCLUSION: During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred.

Risk for Colorectal Adenomas Among Patients with Pancreatic Intraductal Papillary Mucinous Neoplasms: a Prospective Case-Control Study.

BACKGROUND AND AIMS: It has been reported that patients with intraductal papillary mucinous neoplasms of the pancreas are at an increased risk of colorectal cancer. The aim of our study was to investigate whether patients with intraductal papillary mucinous neoplasms are at a higher risk of colorectal adenomas with respect to the general population, as this condition represents the precursor of sporadic colorectal cancer. METHODS: A case-control study was conducted at the Catholic University and University Sapienza, Rome, Italy. The cases were patients with intraductal papillary mucinous neoplasms without history of colorectal cancer, who had underwent screening colonoscopy for the first time. The controls were individuals who had underwent first time colonoscopy for screening or evaluation of non-specific abdominal symptoms. Chi-square and Fisher tests were used to compare the distributions of categorical variables. RESULTS: We enrolled 122 cases and 246 controls. Colorectal polyps were found in 52 cases (42.6%) and 79 controls (32.1%) (p<0.05). In 29 cases (23.8%) and 57 controls (23.2%) histological examination disclosed adenomatous polyps (p=0.90). There was no difference between the groups in relation to the presence of polyps with low-grade (19.7% vs. 19.8%, p=0.98) and high-grade dysplasia (4.9% vs. 4.5%, p=0.85). CONCLUSION: Patients with intraductal papillary mucinous neoplasms of the pancreas are not at an increased risk for the development of adenomatous colorectal polyps.