Evaluation of the nurse-assisted eHealth intervention 'eHealth@Hospital-2-Home' on self-care by patients with heart failure and colorectal cancer post-hospital discharge: protocol for a randomised controlled trial.

BACKGROUND: Patients with heart failure (HF) and colorectal cancer (CRC) are prone to comorbidity, a high rate of readmission, and complex healthcare needs. Self-care for people with HF and CRC after hospitalisation can be challenging, and patients may leave the hospital unprepared to self-manage their disease at home. eHealth solutions may be a beneficial tool to engage patients in self-care. METHODS: A randomised controlled trial with an embedded evaluation of intervention engagement and cost-effectiveness will be conducted to investigate the effect of eHealth intervention after hospital discharge on the self-efficacy of self-care. Eligible patients with HF or CRC will be recruited before discharge from two Norwegian university hospitals. The intervention group will use a nurse-assisted intervention-eHealth@Hospital-2-Home-for six weeks. The intervention includes remote monitoring of vital signs; patients' self-reports of symptoms, health and well-being; secure messaging between patients and hospital-based nurse navigators; and access to specific HF and CRC health-related information. The control group will receive routine care. Data collection will take place before the intervention (baseline), at the end of the intervention (Post-1), and at six months (Post-2). The primary outcome will be self-efficacy in self-care. The secondary outcomes will include measures of burden of treatment, health-related quality of life and 30- and 90-day readmissions. Sub-study analyses are planned in the HF patient population with primary outcomes of self-care behaviour and secondary outcomes of medication adherence, and readmission at 30 days, 90 days and 6 months. Patients' and nurse navigators' engagement and experiences with the eHealth intervention and cost-effectiveness will be investigated. Data will be analysed according to intention-to-treat principles. Qualitative data will be analysed using thematic analysis. DISCUSSION: This protocol will examine the effects of the eHealth@ Hospital-2-Home intervention on self-care in two prevalent patient groups, HF and CRC. It will allow the exploration of a generic framework for an eHealth intervention after hospital discharge, which could be adapted to other patient groups, upscaled, and implemented into clinical practice. TRIAL REGISTRATION: Clinical trials.gov (ID 301472).

eHealth interventions to support colorectal cancer patients' self-management after discharge from surgery-an integrative literature review.

INTRODUCTION: Colorectal cancer (CRC) creates elevated self-management demands and unmet support needs post-discharge. Follow-up care through eHealth post-primary surgery may be an effective means of supporting patients' needs. This integrative review describes the evidence regarding eHealth interventions post-hospital discharge focusing on delivery mode, user-interface and content, patient intervention adherence, impact on patient-reported outcomes and experiences of eHealth. METHODS: A university librarian performed literature searches in 2021 using four databases. After screening 1149 records, the authors read 30 full-text papers and included and extracted data from 26 papers. Two authors analysed the extracted data using the 'framework synthesis approach'. RESULTS: The 26 papers were published between 2012 and 2022. The eHealth interventions were mainly delivered by telephone with the assistance of healthcare professionals, combined with text messages or video conferencing. The user interfaces included websites, applications and physical activity (PA) trackers. The interventions comprised the monitoring of symptoms or health behaviours, patient information, education and counselling. Evidence showed a better psychological state and improved PA. Patients reported high satisfaction with eHealth. However, patient adherence was inadequately reported. CONCLUSIONS: eHealth interventions may positively impact CRC patients' anxiety and PA regardless of the user interface. Patients prefer technology combined with a human element.

Assessing a nurse-assisted eHealth intervention posthospital discharge in adult patients with non-communicable diseases: a protocol for a feasibility study.

INTRODUCTION: A growing number of patients with non-communicable diseases (NCDs), such as heart failure (HF) and colorectal cancer (CRC), are prone to comorbidity, a high rate of readmissions and complex healthcare needs. An eHealth intervention, however, could potentially ameliorate the increasing burdens associated with NCDs by helping to smoothen patient transition from hospital to home and by reducing the number of readmissions. This feasibility study therefore aims to assess the feasibility of a nurse-assisted eHealth intervention posthospital discharge among patients with HF and CRC, while also examining the preliminary clinical and behavioural outcomes of the intervention before initiating a full-scale randomised controlled trial. The recruitment ended in January 2023. METHODS AND ANALYSIS: Twenty adult patients with HF and 10 adult patients with CRC will be recruited from two university hospitals in Norway. Six hospital-based nurse navigators (NNs) will offer support during the transition phase from hospital to home by using a solution for digital remote care, Dignio Connected Care. The patients will use the MyDignio application uploaded to an iPad for 30 days postdischarge. The interactions between patients and NNs will then be assessed through direct observation and qualitative interviews in line with a think-aloud protocol. Following the intervention, semistructured interviews will be used to explore patients' experiences of eHealth support and NNs' experiences of eHealth delivery. The feasibility testing will also comprise a post-test of the Post-System Usability Questionnaire and pretesting of patient-reported outcomes questionnaires, as well as an inspection of user data collected from the software. ETHICS AND DISSEMINATION: The study has been approved by the Norwegian Centre for Research Data (ID.NO: 523386). All participation is based on informed, written consent. The results of the study will be published in open-access, peer-reviewed journals and presented at international and national scientific conferences and meetings.

Characteristics and fate of patients with rectal cancer not entering a curative-intent treatment pathway: A complete nationwide registry cohort of 3,304 patients.

BACKGROUND: Treatment options for advanced and metastatic rectal cancer have increased during the past decades. However, a considerable proportion of the patients are not eligible for curative treatment, and data on this subset are scarce from a population-based perspective. This study aimed to describe treatment pathways and survival in a national cohort of patients with primary stage IV rectal cancer or stage I-III rectal cancer not eligible for curative treatment. METHODS: A national cohort of all patients reported 2008-2015 to the Norwegian Colorectal Cancer Registry with primary metastatic rectal cancer or who did not undergo curative resections for stage I-III rectal cancer was studied with regard to patient characteristics, treatments, and survival. RESULTS: Of 8291 patients diagnosed with rectal cancer, 3304 (39.9%) were eligible for analysis. The majority (76.8%) had metastatic disease, and 23.2% did not undergo curative resections for other reasons. We identified four main treatment journeys: no tumour-directed treatment, 25.1%; resection of the primary tumour, 44.6%; oncological treatment, 28.4%; and R0 resection of the primary tumour and metastases, 1.9%; these translated into ten different treatment pathways. Survival differed considerably between a median of 5.3 months for M1 disease with non-tumour-directed treatment to a five-year survival of 67% for M1 with R0 resection. CONCLUSION: Almost 40% of all patients with rectal cancer did not enter a curative-intent treatment pathway. The patient journeys and outcomes varied greatly. This large but understudied population warrants further in-depth analyses of treatment efficacy and effects on quality of life.

Cancer-related fatigue and treatment burden in surgically treated colorectal cancer patients - A cross-sectional study.

OBJECTIVE: This cross-sectional study aimed to describe cancer-related fatigue (CRF) in colorectal cancer (CRC) patients who were surgically treated with curative intent, identify subgroups at risk of elevated fatigue levels and explore associations between CRF and treatment burden. BACKGROUND: CRF is a prominent symptom among cancer patients. In patients treated for CRC, CRF is associated with adjuvant treatments, low quality of life and reduced ability to self-manage. METHODS: One hundred thirty-four patients with CRC treated at a Norwegian university hospital between 2016-2018 were included. The Schwartz Cancer Fatigue Scale-6 and the Patient Experience with Treatment and Self-management questionnaires were applied for data collection. Statistical analyses included descriptive statistics and non-parametric approaches to analyse correlations and identify differences between groups. The study adhered to STROBE Statement checklist for reporting of cross-sectional studies. RESULTS: Median fatigue level was 10.0 (range: 7.0-13.0). Physical fatigue was higher than perceptual fatigue, with medians of 6.0 (interquartile range [IQR]: 3.0-13.0) and 4.0 (IQR: 3.0-12.0), respectively. Higher fatigue levels were associated with age <60 years, advanced cancer and adjuvant treatments. Increased CRF was significantly associated with higher treatment burden on seven of the nine dimensions, adjusted for demographic and clinical variables. The association of fatigue and treatment burden was stronger in survivors <60 years, with advanced cancer, 6-12 months since surgery or who had more comorbid conditions. CONCLUSIONS: This study showed patients at risk of experiencing CRF following CRC treatment. It established proof of associations between CRF and treatment burden and identified subgroups of CRC patients where this association was stronger. RELEVANCE TO CLINICAL PRACTICE: Screening of CRF in CRC patients can help clinicians provide individualized treatment and care to manage CRF. Clinicians should consider the association between CRF and treatment burden, especially in subgroups of CRF patients.

The overriding role of surgery and tumor grade for long-term survival in patients with gastroenteropancreatic neuroendocrine neoplasms: A population-based cohort study.

BACKGROUND: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) comprise a heterogeneous disease group. Factors that affect long-term survival remain uncertain. Complete population-representative cohorts with long-term follow-up are scarce. AIM: To evaluate factors of importance for the long-term survival. METHODS AND RESULTS: An Observational population-based study on consecutive GEP-NEN patients diagnosed from 2003 to 2013, managed according to national guidelines. Univariable and multivariable survival analyses were performed to evaluate overall survival (OS) and to identify independent prognostic factors. One hundred ninety eligible patients (males, 58.9%) (median age, 60.0 years; range, 10.0-94.2 years) were included. The small bowel, appendix, and pancreas were the most common tumor locations. The World Health Organization (WHO) tumor grade 1-3 distributions varied according to the primary location and disease stage. Primary surgery with curative intent was performed in 66% of the patients. The median OS of the study population was 183 months with 5- and 10-year OS rates of 66% and 57%, respectively. Only age, WHO tumor grade, and primary surgical treatment were independent prognostic factors for OS. CONCLUSION: The outcomes of GEP-NEN patients are related to several factors including age and primary surgical treatment. WHO tumor grading, based on the established criteria, should be routine in clinical practice. This may improve clinical decision-making and allow the comparison of outcomes among different centers.

Intra-observer agreements in multidisciplinary team assessments of pancreatic cancer patients.

BACKGROUND AND METHODS: Treatment strategies for pancreatic cancer patients are made by a multidisciplinary team (MDT) board. We aimed to assess intra-observer variance at MDT boards. Participating units staged, assessed resectability, and made treatment allocations for the same patients as they did two years earlier. We disseminated clinical information and CT images of pancreatic cancer patients judged by one MDT board to have nonmetastatic pancreatic cancer to the participating units. All units were asked to re-assess the TNM stage, resectability, and treatment allocation for each patient. To assess intra-observer variance, we computed %-agreements for each participating unit, defined as low (<50%), moderate (50%-75%), and high (>75%) agreement. RESULTS: Eighteen patients were re-assessed by six MDT boards. The overall agreement was moderate for TNM-stage (ranging from 50%-70%) and resectability assessment (53%) but low for treatment allocation (46%). Agreement on resectability assessments was low to moderate. Findings were similar but more pronounced for treatment allocation. We observed a shift in treatment strategy towards increasing use of neoadjuvant chemotherapy, particularly in patients with borderline resectable and locally advanced tumors. CONCLUSIONS: We found substantial intra-observer agreement variations across six different MDT boards of 18 pancreatic cancer patients with two years between the first and second assessment.

Post hepatectomy liver failure (PHLF) - Recent advances in prevention and clinical management.

BACKGROUND: Posthepatectomy liver failure (PHLF) is a relatively rare but feared complication following liver surgery, and associated with high morbidity, mortality and cost implications. Significant advances have been made in detailed preoperative assessment, particularly of the liver function in an attempt to predict and mitigate this complication. METHODS: A detailed search of PubMed and Medline was performed using keywords "liver failure", "liver insufficiency", "liver resection", "postoperative", and "post-hepatectomy". Only full texts published in English were considered. Particular emphasis was placed on literature published after 2015. A formal systematic review was not found feasible hence a pragmatic review was performed. RESULTS: The reported incidence of PHLF varies widely in reported literature due to a historical absence of a universal definition. Incorporation of the now accepted definition and grading of PHLF would suggest the incidence to be between 8 and 12%. Major risk factors include background liver disease, extent of resection and intraoperative course. The vast majority of mortality associated with PHLF is related to sepsis, organ failure and cerebral events. Despite multiple attempts, there has been little progress in the definitive and specific management of liver failure. This review article discusses recent advances made in detailed preoperative evaluation of liver function and evidence-based targeted approach to managing PHLF. CONCLUSION: PHLF remains a major cause of mortality following liver resection. In absence of a specific remedy, the best approach is mitigating the risk of it happening by detailed assessment of liver function, patient selection and general care of a critically ill patient.

A Plasma Protein Biomarker Strategy for Detection of Small Intestinal Neuroendocrine Tumors.

BACKGROUND: Small intestinal neuroendocrine tumors (SI-NETs) are difficult to diagnose in the early stage of disease. Current blood biomarkers such as chromogranin A (CgA) and 5-hydroxyindolacetic acid have low sensitivity (SEN) and specificity (SPE). This is a first preplanned interim analysis (Nordic non-interventional, prospective, exploratory, EXPLAIN study [NCT02630654]). Its objective is to investigate if a plasma protein multi-biomarker strategy can improve diagnostic accuracy (ACC) in SI-NETs. METHODS: At the time of diagnosis, before any disease-specific treatment was initiated, blood was collected from patients with advanced SI-NETs and 92 putative cancer-related plasma proteins from 135 patients were analyzed and compared with the results of age- and sex-matched controls (n = 143), using multiplex proximity extension assay and machine learning techniques. RESULTS: Using a random forest model including 12 top ranked plasma proteins in patients with SI-NETs, the multi-biomarker strategy showed SEN and SPE of 89 and 91%, respectively, with negative predictive value (NPV) and positive predictive value (PPV) of 90 and 91%, respectively, to identify patients with regional or metastatic disease with an area under the receiver operator characteristic curve (AUROC) of 99%. In 30 patients with normal CgA concentrations, the model provided a diagnostic SPE of 98%, SEN of 56%, and NPV 90%, PPV of 90%, and AUROC 97%, regardless of proton pump inhibitor intake. CONCLUSION: This interim analysis demonstrates that a multi-biomarker/machine learning strategy improves diagnostic ACC of patients with SI-NET at the time of diagnosis, especially in patients with normal CgA levels. The results indicate that this multi-biomarker strategy can be useful for early detection of SI-NETs at presentation and conceivably detect recurrence after radical primary resection.

Elevated Microsatellite Alterations at Selected Tetranucleotides (EMAST) in Colorectal Cancer is Associated with an Elderly, Frail Phenotype and Improved Recurrence-Free Survival.

BACKGROUND: Elevated microsatellite alterations at selected tetranucleotides (EMAST) is a poorly investigated form of microsatellite instability (MSI) in colorectal cancer (CRC). OBJECTIVE: The aim of this study was to investigate the clinicopathological features of EMAST in CRC and its relation to outcome. METHODS: A population-based, consecutive cohort of surgically treated stage I-III CRC patients investigated for high-frequency MSI (MSI-H) and EMAST. Clinicopathological differences were reported as odds ratios (OR) and survival was presented as hazard ratios (HR) with 95% confidence intervals (CIs). RESULTS: Of 161 patients included, 25% were aged > 79 years. There was a large overlap in the prevalence of EMAST (31.7%) and MSI-H (27.3%) [82.4% of EMAST were also MSI-H]. EMAST had the highest prevalence in the proximal colon (OR 15.9, 95% CI 5.6-45.1; p < 0.001) and in women (OR 4.1, 95% CI 1.9-8.6; p < 0.001), and were poorly differentiated (OR 5.0, 95% CI 2.3-10.7; p < 0.001). Compared with EMAST-negative patients, EMAST-positive patients were older (median age 77 vs. 69 years; p < 0.001), leaner (median weight 67.5 vs. 77 kg; p = 0.001), had significantly higher rates of hypoalbuminemia (24% vs. 6%; OR 2.3, 95% CI 1.5-3.6; p = 0.002) and anemia (45% vs. 20%; OR 3.3, 95% CI 1.6-6.8; p = 0.001), and had elevated preoperative C-reactive protein (CRP) levels (51% vs. 34%; OR 1.9, 95% CI 1.0-3.9; p = 0.046). Improved recurrence-free survival was found in both MSI-H and EMAST subtypes. In multivariable analysis, node status (pN +), together with elevated CRP and MSI-positive, were the strongest prognostic factors for recurrence-free survival. CONCLUSIONS: EMAST in CRC is associated with an older, leaner, and frailer phenotype with a lower risk of recurrence. The relevance of, and putative mechanisms to, EMAST warrants further investigation.

Roar Strøm - the Norwegian surgeon who was three years ahead of Zollinger and Ellison. / Roar Strøm ­ kirurgen som kom Zollinger og Ellison i forkjøpet.

BACKGROUND: In 1952, Norwegian surgeon Roar Strøm (1903-58) published the medical history of a 32-year-old man with recurrent peptic ulcer disease and a pancreatic tumour. Three years later, two American surgeons described a similar condition and, only the following year, the condition was named after them: Zollinger-Ellison syndrome. Strøm's contribution has gone remarkably unrecognised. This article aims to highlight his professional achievements. MATERIAL AND METHOD: We searched archives and reference databases for information on Roar Strøm. RESULTS: Roar Strøm grew up in Oslo, where he graduated with a medical degree in 1926, at just 23 years of age. Strøm pursued a focused career in surgery: specialist in surgery in 1935, medical doctorate in 1942, and senior consultant in surgery at Rogaland Hospital in Stavanger over the period 1945-1956. While in Stavanger, he published the extensive case history in Acta Chirurgica Scandinavica. The patient had a multi-year medical history of peptic ulcers, for which he had undergone surgery twice previously before being operated on by Strøm in the spring of 1951. The man died two years after the last operation. INTERPRETATION: Neither Strøm nor Zollinger and Ellison were the first to identify this clinical condition as a new disease entity. But Strøm's article was an important contribution to the early literature on the syndrome.

Palliative surgical outcome score (PSOS) in patients treated palliatively with self-expanding metal stent (SEMS) for malignant incurable colorectal obstruction.

AIM: The palliative surgical outcome score (PSOS) was proposed for evaluation of the effect of palliative surgical interventions. As a surrogate measure for successful symptom control, it is defined as the proportion of days outside the hospital of the remaining life time up to six months after a palliative intervention. In this study we evaluate the PSOS in patients treated palliatively with self-expanding metal stents (SEMSs) for incurable malignant colorectal obstruction. METHODS: All eligible patients endoscopically treated with palliative intent with SEMSs were identified. Demographics and clinical characteristics, including complete follow-up, were recorded, and the PSOS was calculated. Non-parametric tests were used for comparisons, and survival was evaluated by univariable and multivariable analyses. RESULTS: Between 2005 and 2013, 116 patients (median age 71.5 years; 53.4% women) were identified. Most obstructions were caused by primary colorectal cancers. Technical- and clinical success rates were 94.0% and 87.1%, respectively. Procedure-related complications occurred in 17 (14.7%) of the patients, and most were minor. A PSOS>70 (regarded as excellent palliation) was achieved in 79 (68.1%) patients. This goal was significantly more often achieved in patients who survived at least 6 months than in those with shorter survival (p < 0.001). No clinical variables at the time of the endoscopic palliative procedure could predict a PSOS>70. However, in patients who survived at least 6 months (n = 69), a PSOS>70 was independently associated with better survival in the multivariable Cox analysis. CONCLUSIONS: PSOS could be used as a practical proxy or a pragmatic tool for the effectiveness of palliative interventions, when such interventions are compared. Clinical factors that could significantly add to the clinical decision-making and predict a PSOS>70 in an individual patient were not identified for this specific group of patients.

Endoscopic retrograde cholangiopancreatography (ERCP): lessons learned from population-based national registries: a systematic review.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) was introduced more than four decades ago as a diagnostic tool for biliary and pancreatic diseases. Currently, ERCP is mainly used as a therapeutic approach to relieve biliary or pancreatic duct obstruction. Clinical practice has been based on a few large reports and some randomized controlled trials. These data are valuable and important, but the external validity of these reports is limited. Implementation into routine practice should be balanced with the knowledge that these studies were conducted under very specific circumstances. This review was undertaken to describe ERCP results from population-based national registries recorded during routine clinical practice. METHODS: A systematic literature search of the electronic databases Medline Ovid and Embase was conducted. Eligible papers were selected and data were recorded according to the PRISMA criteria. RESULTS: Thirty-one studies were included: 15 true national population-based and 16 population-level studies. Most studies originated from countries with a governmental public health care system. At least three-quarters of the ERCP procedures are currently therapeutic, and the technical success rate is high (> 90%). The postprocedure 30-day mortality rate ranged between 1 and 5% and was strongly correlated with older age, male sex, emergency admission, and noncancer comorbidities, but exhibited a lower correlation with the annual ERCP volume. Patients with primary sclerosing cholangitis or liver cirrhosis should receive particular attention. The risk of developing a bile duct, liver, or pancreas malignancy after ERCP tended to increase, but endoscopic sphincterotomy did not affect this risk. CONCLUSION: ERCP is currently mainly used as a therapeutic approach, and the results are generally likely to improve patients' conditions. A nationwide registry enables better monitoring of routine clinical practice. The collection of valuable information from routine clinical practice in population-based databases may help to improve patient care from best evidence to best practice.

Therapeutic Approaches to Gastric Hepatoid Adenocarcinoma: Current Perspectives.

Hepatoid adenocarcinoma of the stomach (HAS) is a rare subgroup of gastric cancer (GC). Morphologically, this tumor exhibits both adenocarcinomatous and hepatocellular differentiation, and most tumors show immunohistochemical staining for alpha-fetoprotein (AFP) or elevated AFP serum levels. The diagnosis of HAS is frequently delayed, and at least half of patients have advanced disease at the time of diagnosis. Despite a lack of evidence, treatment approaches have mostly followed principles for the treatment of common gastric cancer (CGC), including radical surgery in eligible patients with curative intent. The indications for and the type of adjuvant systemic treatments remain unclear. Additionally, there is a lack of evidence allowing any firm conclusions to be drawn regarding the best treatment for patients with metastatic HAS (mHAS). Chemotherapy regimens, including cisplatin-based chemotherapy, are considered the most efficient first-line systemic treatment in advanced situations. Their combination with targeted therapy (i.e., trastuzumab) in HER2-positive tumors seems promising. The rarity of these patients and the scarce and heterogeneous literature on this particular subgroup of GC make it difficult to provide any robust evidence for the clinical management of patients with HAS.

The Prognostic Relevance of Sentinel Lymph Node Metastases Assessed by PHGR1 mRNA Quantification in Stage I to III Colon Cancer.

BACKGROUND: Regional lymph node (LN) metastasis is a strong and well-established prognostic factor in colon cancer, and recent data suggest a prognostic value of detecting micrometastases and isolated tumor cells in regional LNs. The aim of the study was to investigate the clinical relevance of detecting sentinel lymph node (SLN) metastases in colon cancer patients by measuring the novel metastasis marker PHGR1 mRNA. METHODS: Using quantitative reverse-transcription polymerase chain reaction, we measured PHGR1 mRNA levels in SLNs and primary tumors from 206 patients surgically treated for stage I to III colon cancer and 52 normal LNs from patients undergoing surgery for benign colon diseases. The prognostic impact of these findings was evaluated by Kaplan-Meier analysis and Cox proportional-hazards regression. RESULTS: Compared to normal LNs, elevated PHGR1 mRNA levels were detected in SLNs from 56 (89%) of the 63 patients with pN+ disease. Furthermore, 68 (48%) of the 143 node-negative (pN0) patients had elevated PHGR1 mRNA levels in SLNs, suggesting occult metastases. With a median follow-up of 7.2 years, a significantly shorter recurrence-free (P=.005) and disease-specific (P=.02) survival was observed in patients with elevated PHGR1 mRNA levels in SLNs. Multivariable modeling showed that the SLN PHGR1 mRNA level was an independent prognostic factor. However, when the survival analyses were restricted to pN0 patients, no significant prognostic information was found. CONCLUSION: Measuring PHGR1 mRNA in SLNs provided independent prognostic information on operable colon cancer patients but not in the pN0 subgroup.

Compensation Claims for Sub-substandard Care of Patients with Gastroentero-pancreatic Neuroendocrine Tumors: A Nationwide Descriptive Study of Cases Between 2005-2016 in Norway.

BACKGROUND: Management of patients with neuroendocrine tumors of the gastrointestinal tract or pancreas (GEP-NENs) poses diagnostic and therapeutic challenges. This study described the medico-legal claims reported to a national governmental system that oversees compensation to patients with GEP-NENs Materials and Methods: An electronic search of the Norwegian System of Compensation to Patients database was performed to identify claims evaluated between 2005-2016. The clinical information and the medico-legal evaluation were reviewed. RESULTS: We identified seven patients, five women and two men, with a median age of 57 (range=47-73) years. Delayed diagnosis (median diagnostic delay of 18 (range=6-48) months) was the main cause for claims in six out of the seven patients). Four patients received financial compensation based on the claim judgement. CONCLUSION: This review of claims that were evaluated by the Norwegian System of Compensation to Patients showed that a timely diagnosis of GEP-NENs remains a clinical challenge.

Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer (Norwegian Pancreatic Cancer Trial - 1 (NorPACT-1)) - study protocol for a national multicentre randomized controlled trial.

BACKGROUND: Pancreatic cancer is the fourth leading cause of cancer-related death. While surgical resection remains the foundation for potentially curative treatment, survival benefit is achieved with adjuvant oncological treatment. Thus, completion of multimodality treatment (surgical resection and (neo)adjuvant chemotherapy) to all patients and early treatment of micrometastatic disease is the ideal goal. NorPACT-1 aims to test the hypothesis that overall mortality at one year after allocation of treatment can be reduced with neoadjuvant chemotherapy in surgically treated patients with resectable pancreatic cancer. METHODS/DESIGN: The NorPACT- 1 is a multicentre, randomized controlled phase III trial organized by the Norwegian Gastrointestinal Cancer Group for Hepato-Pancreato-Biliary cancer. Patients with resectable adenocarcinoma of the pancreatic head are randomized to receive either surgery first (Group 1: SF/control) or neoadjuvant chemotherapy (Group 2: NT/intervention) with four cycles FOLFIRINOX followed by resection. Both groups receive adjuvant chemotherapy with gemicitabine and capecitabine (six cycles in Group 1, four cycles in Group 2). In total 90 patients will be randomized in all the five Norwegian university hospitals performing pancreatic surgery. Primary endpoint is overall mortality at one year following commencement of treatment for those who ultimately undergo resection. Secondary endpoints are overall survival after date of randomization (intention to treat), overall survival after resection, disease-free survival, histopathological response, complication rates after surgery, feasibility of neoadjuvant and adjuvant chemotherapy, completion rates of all parts of multimodal treatment, and quality-of-life. Bolt-on to the study is a translational research program that aims at identifying factors that are predictive of response to NT, the risk of distant cancer spread, and patient outcome. DISCUSSION: NorPACT- 1 is designed to investigate the additional benefit of NT compared to standard treatment only (surgery + adjuvant chemotherapy) for resectable cancer of the pancreatic head to decrease early mortality (within one year) in resected patients. TRIAL REGISTRATION: Trial open for accrual 01.02.2017. ClinicalTrials.gov Identifier: NCT02919787 . Date of registration: September 14, 2016.

Intramural gastric pseudocyst: A case report and a comprehensive literature review.

RATIONALE: Intramural pseudocyst, although first reported several decades ago, is a rare entity. Scientific knowledge regarding its clinical management is sparse. PATIENT CONCERNS: We present three cases to show the diverse clinical patterns of patients diagnosed with an intramural gastric pseudocyst. DIAGNOSIS: A final diagnosis should rest on proper evaluation by cross sectional imaging, including computer tomography and magnetic resonance imaging. Endoscopic ultrasound adds to the work-up. INTERVENTIONS: Previously, identified "lesions of the gastric wall" were not well recognized as an intramural pseudocyst, and treatments including resectional surgery were employed. Contemporary proper diagnostics should provide support to a less aggressive treatment approach. OUTCOMES: While an indolent natural history without any clinical symptoms or discomfort could be expected in most cases, individual clinical evaluation should be applied. LESSONS: A heterogeneous information pattern from the limited number of cases in the literature makes it difficult to draw any firm conclusions. Attention to this rare condition should be increased to help clinicians arrive at a correct diagnosis and possibly prevent some patients from being over treated or from the use of unnecessary surgery.