Abstract Background Chronic pancreatitis is a complex disease with many unanswered questions regarding the natural history and therapy. Prospective longitudinal studies with long-term follow-up are ...warranted. Methods The Dutch Chronic Pancreatitis Registry (CARE) is a nationwide registry aimed at prospective evaluation and follow-up of patients with chronic pancreatitis. All patients with (suspected) chronic or recurrent pancreatitis are eligible for CARE. Patients are followed-up by yearly questionnaires and review of medical records. Study outcomes are pain, disease complications, quality of life, and pancreatic function. The target sample size was set at 500 for the first year and 1000 patients within 3 years. Results A total of 1218 patients were included from February 2010 until June 2013 by 76 participating surgeons and gastroenterologist from 33 hospitals. Participation rate was 90% of eligible patients. Eight academic centers included 761 (62%) patients, while 25 community hospitals included 457 (38%). Patient centered outcomes were assessed by yearly questionnaires, which had a response rate of 85 and 82% for year 1 and 2, respectively. The median age of patients was 58 years, 814 (67%) were male, and 38% had symptoms for less than 5 years. Discussion The CARE registry has successfully recruited over 1200 patients with chronic and recurrent pancreatitis in about 3 years. The defined inclusion criteria ensure patients are included at an early disease stage. Participation and compliance rates are high. CARE offers a unique opportunity with sufficient power to investigate many clinical questions regarding natural course, complications, and efficacy and timing of treatment strategies.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these ...patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients.
The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation.
The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications.
Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012).
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal ...fashion resulting in relatively low radical (R0)-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. We aim to evaluate the (cost-)effectiveness of ESD against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months). We hypothesize that in the short-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the long-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with less need for repeated procedures.
This is a multicenter randomized clinical trial in patients with a non-pedunculated polyp larger than 20 mm in the rectum, sigmoid, or descending colon suspected to be an adenoma by means of endoscopic assessment. Primary endpoint is recurrence rate at follow-up colonoscopy at 6 months. Secondary endpoints are R0-resection rate, perceived burden and quality of life, healthcare resources utilization and costs, surgical referral rate, complication rate and recurrence rate at 36 months. Quality-adjusted-life-year (QALY) will be estimated taking an area under the curve approach and using EQ-5D-indexes. Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.
If this trial confirms ESD to be favorable on the long-term, the burden of extra colonoscopies and repeated procedures can be prevented for future patients.
NCT02657044 (Clinicaltrials.gov), registered January 8, 2016.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction. In patients with acute pancreatitis (AP), nutritional support is required if normal food cannot be tolerated within several days. Enteral nutrition is preferred over parenteral ...nutrition. We reviewed the literature about enteral nutrition in AP. Methods. A MEDLINE search of the English language literature between 1999–2009. Results. Nasogastric tube feeding appears to be safe and well tolerated in the majority of patients with severe AP, rendering the concept of pancreatic rest less probable. Enteral nutrition has a beneficial influence on the outcome of AP and should probably be initiated as early as possible (within 48 hours). Supplementation of enteral formulas with glutamine or prebiotics and probiotics cannot routinely be recommended. Conclusions. Nutrition therapy in patients with AP emerged from supportive adjunctive therapy to a proactive primary intervention. Large multicentre studies are needed to confirm the safety and effectiveness of nasogastric feeding and to investigate the role of early nutrition support.
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FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK
Summary
Background Following a nil per os (NPO) regimen, most patients with acute pancreatitis (AP) can resume normal oral intake within 1 week. If not tolerated, it is recommended to initiate ...artificial feeding, preferably by the enteral route.
Aim To evaluate the nutritional management of patients with AP in a Dutch cohort (EARL study).
Methods Observational study in 18 hospitals. Total days of NPO, tube feeding (TF) with/without oral feeding, total parenteral nutrition (TPN) and total starvation time were analysed.
Results In mild AP, a majority of cases (80.7%, 117/145) were managed with an NPO regimen only. Twenty‐seven patients (18.6%) with mild AP additionally received TF; one received TPN. Of those with severe AP, more than half of the patients (56.2%, nine of 16) were treated with TF besides an NPO regimen; four received TPN. TF was delivered preferably via the jejunal route. The median period of total starvation was 2 days for both mild and severe AP. Only 5.5% (nine of 164) of patients had a prolonged starvation time of more than 5 days.
Conclusions The total time of starvation was limited in a majority of patients admitted for AP. According to international guidelines, additional nutritional interventions were quickly undertaken with enteral feeding via the jejunum as the preferred route.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
The Large Magellanic Cloud, a satellite galaxy of the Milky Way, has been observed with the High Energy Stereoscopic System (H.E.S.S.) above an energy of 100 billion electron volts for a deep ...exposure of 210 hours. Three sources of different types were detected: the pulsar wind nebula of the most energetic pulsar known, N 157B; the radio-loud supernova remnant N 132D; and the largest nonthermal x-ray shell, the superbubble 30 Dor C. The unique object SN 1987A is, unexpectedly, not detected, which constrains the theoretical framework of particle acceleration in very young supernova remnants. These detections reveal the most energetic tip of a γ-ray source population in an external galaxy and provide via 30 Dor C the unambiguous detection of γ-ray emission from a superbubble.
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BFBNIB, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
Aim
Most people who are at increased familial colorectal cancer (FCRC) risk are not identified, despite the need for enhanced surveillance colonoscopy for effective CRC prevention. An online ...self‐test may enhance this identification. We assessed whether taking an online self‐test to identify increased FCRC risk increases anxiety, distress or CRC risk perception in population‐based CRC screening.
Method
After the precolonoscopy consultation, patients who had a positive immunohistochemical occult faecal blood test (iFOBT+) in population‐based CRC screening were invited by email to take an online self‐test at home which returned details of family history. Anxiety (STAI‐DY), distress (HADS) and CRC risk perception were assessed immediately before and after taking the online self‐test and 2 weeks later.
Results
Of 250 participants invited, 177 (71%) completed the online self‐test and psychological questionnaires and 153 (61%) completed questionnaires 2 weeks later. The median age was 65 years (range 61–75). The FCRC risk was increased in 17 participants (9.6%). Of these, 12 (6.8%) had a highly increased FCRC risk and may benefit from germline genetic testing for Lynch syndrome. In 7 of 17 participants (40%) the self‐test obtained novel information on family history. Anxiety and distress levels were, and remained, below a clinically relevant level. Perception of CRC risk remained unchanged. Most participants (83%) would recommend the online self‐test to others.
Conclusion
Of those with a iFOBT+, 9.6% had a previously unidentified increasedFCRC risk and require an enhanced surveillance colonoscopy instead of iFOBT. As screening for this risk did not increase anxiety or distress, and was highly acceptable, we recommend adding the online self‐test to population‐based CRC screening.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Abstract
Background and study aims
A free resection margin (FRM) > 1 mm after local excision of a T1 colorectal cancer (CRC) is known to be associated with a low risk of local intramural residual ...cancer (LIRC). The risk is unclear, however, for FRMs between 0.1 to 1 mm. This study evaluated the risk of LIRC after local excision of T1 CRC with FRMs between 0.1 and 1 mm in the absence of lymphovascular invasion (LVI), poor differentiation and high-grade tumor budding (Bd2–3).
Patients and methods
Data from all consecutive patients with local excision of T1 CRC between 2014 and 2017 were collected from 11 hospitals. Patients with a FRM ≥ 0.1 mm without LVI and poor differentiation were included. The main outcome was risk of LIRC (composite of residual cancer in the local excision scar in adjuvant resection specimens or local recurrence during follow-up). Tumor budding was also assessed for cases with a FRM between 0.1 and 1mm.
Results
A total of 171 patients with a FRM between 0.1 and 1 mm and 351 patients with a FRM > 1 mm were included. LIRC occurred in five patients (2.9 %; 95 % confidence interval CI 1.0–6.7 %) and two patients (0.6 %; 95 % CI 0.1–2.1 %), respectively. Assessment of tumor budding showed Bd2–3 in 80 % of cases with LIRC and in 16 % of control cases. Accordingly, in patients with a FRM between 0.1 and 1 mm without Bd2–3, LIRC was detected in one patient (0.8%; 95 % CI 0.1–4.4 %).
Conclusions
In this study, risks of LIRC were comparable for FRMs between 0.1 and 1 mm and > 1 mm in the absence of other histological risk factors.
Extensive population‐based studies are much needed to accurately establish epidemiology and disease course in patients with primary sclerosing cholangitis (PSC). We aimed to obtain population‐based ...prevalence and incidence figures, insight in disease course with regard to survival, liver transplantation (LT), and occurrence of malignancies, as well as risk factors thereof. Four independent hospital databases were searched in 44 hospitals in a large geographically defined area of the Netherlands, comprising 50% of the population. In addition, all PSC patients in the three Dutch liver transplant centers and all inflammatory bowel disease (IBD) patients in the adherence area of a large district hospital were identified. All medical records were reviewed on‐site, verifying diagnosis. Five hundred and ninety PSC patients were identified, resulting in an incidence of 0.5 and a point prevalence of 6.0 per 100,000. Median follow up was 92 months. Estimated median survival from diagnosis until LT or PSC‐related death in the entire cohort was 21.3 years, as opposed to 13.2 years in the combined transplant centers cohort (n = 422; P < 0.0001). Colorectal carcinoma (CRC) risk was 10‐fold increased, as compared to ulcerative colitis controls, and developed at a much younger age (39 years; range, 26‐64), compared to IBD controls (59 years; range, 34‐73; P = 0.019). Colonoscopic surveillance was associated with significantly better outcome. Conclusion: This study exemplifies that, for relatively rare diseases, it is paramount to collect observational data from large, population‐based cohorts, because incidence and prevalence rates of PSC are markedly lower and survival much longer than previously reported. The selection of a bias‐free, population‐based cohort showed a significantly longer survival, compared to the tertiary referral cohort. CRC can develop at an early age, warranting surveillance from time of PSC diagnosis. (Hepatology 2013; 58:2045–2055)
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
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