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Background & Aims: Previous randomized trials, including the Transluminal Endoscopic Step-Up Approach Versus Minimally Invasive Surgical Step-Up Approach in Patients With Infected Pancreatic Necrosis (TENSION) trial, demonstrated that the endoscopic step-up approach might be preferred over the surgical step-up approach in patients with infected necrotizing pancreatitis based on favorable short-term outcomes. We compared long-term clinical outcomes of both step-up approaches after a period of at least 5 years.Methods: In this long-term follow-up study, we reevaluated all clinical data on 83 patients (of the originally 98 included patients) from the TENSION trial who were still alive after the initial 6-month follow-up. The primary end point, similar to the TENSION trial, was a composite of death and major complications. Secondary end points included individual major complications, pancreaticocutaneous fistula, reinterventions, pancreatic insufficiency, and quality of life.Results: After a mean follow-up period of 7 years, the primary end point occurred in 27 patients (53%) in the endoscopy group and in 27 patients (57%) in the surgery group (risk ratio [RR], 0.93; 95% confidence interval [CI], 0.65–1.32; P = .688). Fewer pancreaticocutaneous fistulas were identified in the endoscopy group (8% vs 34%; RR, 0.23; 95% CI, 0.08–0.83). After the initial 6-month follow-up, the endoscopy group needed fewer reinterventions than the surgery group (7% vs 24%; RR, 0.29; 95% CI, 0.09–0.99). Pancreatic insufficiency and quality of life did not differ between groups.Conclusions: At long-term follow-up, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing death or major complications in patients with infected necrotizing pancreatitis. However, patients assigned to the endoscopic approach developed overall fewer pancreaticocutaneous fistulas and needed fewer reinterventions after the initial 6-month follow-up. Netherlands Trial Register no: NL8571.

Background and Aims: With the introduction of the national bowel cancer screening program, the detection of sessile and flat colonic lesions >= 20 mmin size, defined as large nonpedunculated colorectal polyps (LNPCPs), has increased. The aim of this study was to examine the quality of endoscopic treatment of LNPCPs in the Dutch screening program.Methods: This investigation comprised 2 related, but separate, substudies (1 with a cross-sectional design and 1 with a longitudinal design). The first examined prevalence and characteristics of LNPCPs in data from the national Dutch screening cohort from February 2014 until January 2017. The second, with screening data from 5 endoscopy units in the Southern part of the Netherlands from February 2014 until August 2015, examined performance on important quality indicators (technical and clinical successes, recurrence rate, adverse event rate, and surgery referral rate). All patients were part of the national Dutch screening cohort.Results: In the national cohort, an LNPCP was detected in 8% of participants. Technical and clinical success decreased with increasing LNPCP size, from 93% and 96% in 20- to 29-mm lesions to 85% and 86% in 30- to 39-mm lesions and to 74% and 81% in >= 40-mm lesions (P = 30-mm polyps. Endoscopic resection of large polyps could benefit from additional training, quality monitoring, and centralization either within or between centers.

Background In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. Methods Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. Discussion This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. Trial registration Netherlands Trial Register, NL7083, 06 July 2018.

SummaryBackground Infliximab biosimilars have become available for treatment of inflammatory bowel disease (IBD). However, data showing long-term safety and effectiveness of biosimilars in IBD patients are limited. Aim To study prospectively the switch from infliximab innovator to biosimilar in an IBD cohort with 12 months follow-up to evaluate safety and effectiveness. Methods Adult IBD patients from two hospitals treated with infliximab innovator (Remicade; Janssen Biotech, Horsham , Pennsylvania, USA) were switched to infliximab biosimilar (Inflectra; Hospira, Lake Forest, Illinois, USA) as part of routine care, but in a controlled setting. Blood samples were taken just before the first, second, fourth and seventh infusion of biosimilar. Infliximab trough levels, antibodies-to-infliximab (ATI), CRP and ESR were measured and disease activity scores were calculated. Results Our cohort consisted of 133 IBD patients (64% CD, 36% UC). Before switching we found widely varying infliximab levels (median 3.5 μg/mL). ATI were detected in eight patients (6%). Most patients were in remission or had mild disease (CD: 82% UC: 90%). After switching to biosimilar, 35 patients (26%) discontinued therapy within 12 months, mostly due to subjective higher disease activity (9%) and adverse events (AE, 9.8%). AE included general malaise/fatigue (n = 7), arthralgia (n = 2), skin problems (n = 2) and infusion reactions (n = 2). No differences in IFX levels, CRP, and disease activity scores were found between the four time points (P ≥ .0917). Conclusions We found no differences in drug levels and disease activity between infliximab innovator and biosimilar in our IBD cohort, indicating that biosimilars are safe and effective. The high proportions of discontinuers were mostly due to elective withdrawal or subjective disease worsening.

Background Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with 15–20% mortality. The current standard treatment for infected necrotizing pancreatitis is the step-up approach (catheter drainage, followed, if necessary, by minimally invasive necrosectomy). Catheter drainage is preferably postponed until the stage of walled-off necrosis, which usually takes 4 weeks. This delay stems from the time when open necrosectomy was the standard. It is unclear whether such delay is needed for catheter drainage or whether earlier intervention could actually be beneficial in the current step-up approach. The POINTER trial investigates if immediate catheter drainage in patients with infected necrotizing pancreatitis is superior to the current practice of postponed intervention. Methods POINTER is a randomized controlled multicenter superiority trial. All patients with necrotizing pancreatitis are screened for eligibility. In total, 104 adult patients with (suspected) infected necrotizing pancreatitis will be randomized to immediate (within 24 h) catheter drainage or current standard care involving postponed catheter drainage. Necrosectomy, if necessary, is preferably postponed until the stage of walled-off necrosis, in both treatment arms. The primary outcome is the Comprehensive Complication Index (CCI), which covers all complications between randomization and 6-month follow up. Secondary outcomes include mortality, complications, number of (repeat) interventions, hospital and intensive care unit (ICU) lengths of stay, quality-adjusted life years (QALYs) and direct and indirect costs. Standard follow-up is at 3 and 6 months after randomization. Discussion The POINTER trial investigates if immediate catheter drainage in infected necrotizing pancreatitis reduces the composite endpoint of complications, as compared with the current standard treatment strategy involving delay of intervention until the stage of walled-off necrosis. Trial registration ISRCTN, 33682933. Registered on 6 August 2015. Retrospectively registered. Electronic supplementary material The online version of this article (10.1186/s13063-019-3315-6) contains supplementary material, which is available to authorized users.

A 45-year-old woman with morbid obesity (body mass index 44 kg/m²) presented to the emergency department with severe abdominal pain, nausea, vomiting and no defaecation. She had a laparoscopic adjustable gastric banding (LAGB) inserted elsewhere in 2006. No data or follow-up was performed postoperatively. A CT scan demonstrated a perforated LAGB through the gastric antrum (figure 1). Furthermore the connecting tube perforated the small intestine at the level of the proximal part of the jejunum with a partially intraluminally positioned banding (figure 2), causing prestenotic dilatation of the jejunum (figure 3). An upper gastrointestinal endoscopy confirmed an intact port site with a connected tube and migration and perforation of the band into the jejunum with an erosion of the gastric (figure 4) and duodenal …

Endoscopic removal of eroded Lap-Bands is a minimally invasive alternative to surgical removal that prerequires sufficient erosion through the gastric wall, that is, ≥180° of the gastro-oesophageal wall circumference. A 69-year-old woman presented with dysphagia due to a long-standing Lap-Band erosion, currently of a 60° circumference. Adhesions due to her extensive surgical history rendered surgical treatment undesirable, so a self-expanding stent was placed endoscopically to induce sufficient erosion for subsequent endoscopic removal. During therapy, the patient complained of ructus and dysphagia, probably related to an overly proximally (oesophageal) positioned stent. After a total of 12 weeks, far longer than the described stenting duration in the literature, the Lap-Band was found free in the gastric lumen and was successfully removed using an endoscopic loop. Stent-induced compression necrosis should be considered as a minimally invasive treatment option for Lap-Bands eroded for

Contains fulltext : 181861.pdf (Publisher’s version ) (Closed access) BACKGROUND: Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS: In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711. FINDINGS: Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0.97, 95% CI 0.62-1.51; p=0.88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1.38, 95% CI 0.53-3.59, p=0.50), nor did any of the major complications included in the primary endpoint. INTERPRETATION: In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference. FUNDING: The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.

In preparation for any type of forthcoming colorectal cancer (CRC) mass screening we examined trends in CRC incidence and mortality according to sex, subsite and age in southern Netherlands. Population-based data from the Eindhoven Cancer Registry during the period 1975-2004 were used. Age-period-cohort analyses were performed to investigate possible aetiologic, diagnostic or therapeutic origins of the trends. Age-adjusted (European Standardized Rates) incidence rates for colon cancer increased since 1975 from 23 in 100 000 for both sexes to about 38 in 100 000 for males and 30 in 100 000 for females in 2004. Incidence of rectal cancer remained relatively stable at about 25 in 100 000 males and 15 in 100 000 females. The incidence of CRC increased for male patients from birth cohorts between 1900 and 1955 (P = 0.010), especially in left-sided colon cancer in the younger birth cohorts [RR1900: 0.8 (95% confidence interval, CI: 0.6, 1.0), RR1960: 1.6 (95% CI: 0.9, 2.8), reference: 1910-1919]. For women a similar, although weaker increase in CRC incidence was found. Mortality rates for CRC started to decrease in 1975, more pronounced for rectal than for colon cancer. The relative risk for dying in men with CRC decreased from 1.3 (95% CI: 1.0, 1.6) in the 1900 birth cohort to 0.1 (95% CI: 0.1, 0.4) in the 1960 birth cohort, reference 1910-1919 birth cohort. The increasing incidence and decreasing mortality in CRC is largely affected by birth cohort effects. Changes in CRC incidence are likely to be attributed to lifestyle factors and decreasing mortality is due to earlier detection and improved treatment, especially among younger patients. European Journal of Cancer Prevention 18:145-152 (C) 2009 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.

Contains fulltext : 126176.pdf (Publisher’s version ) (Open Access) BACKGROUND: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS/DESIGN: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs. DISCUSSION: The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.

Objective To determine the extent of guideline implementation of the diagnostic approach in patients with colorectal cancer (CRC) in southern Netherlands in 2005, with special focus on colonoscopy. Methods Data were extracted from the medical records for a random sample of 257 colon and 251 rectal cancer patients newly diagnosed in 2005 and recorded from the Eindhoven Cancer Registry. Adherence to guidelines was determined for diagnostic assessment. Multivariable logistic regression analysis was conducted to assess determinants of complete colonoscopy. Results Diagnostic assessment was carried out mainly by internists (50%) and gastroenterologists (36%). Colonoscopy was performed in 83% of patients with proximal/transverse colon cancer, 55% of those with distal colon cancer, and 65% of those with rectal cancer. A tumour biopsy was taken for 84% of colon and 93% of rectal tumours. Colonoscopy completeness was lower for patients with comorbidity, obstructing tumours, and patients with poor bowel preparation. Abdominal ultrasound was performed for 72% of colon and 52% of rectal cancer patients and a thoracic radiography of over 80% of CRC patients. Computed tomography (CT) of the abdomen was performed in over half of the colon cancer patients and a pelvic CT scan or magnetic resonance imaging in 36% of rectal cancer patients. Conclusion Improvements in adherence to diagnostic guidelines for CRC appear possible, especially in the performance of imaging procedures. Among patients where complete visualization of the colon was not feasible with colonoscopy, imaging techniques such as virtual CT might be of added value in the near future. Eur J Gastroenterol Hepatol 21:570-575 (c) 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins.