Wim Hameeteman

A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery.

Background:The endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients. We report on the first European experience with this device. Methods:A multicenter, randomized clinical trial was performed. Forty-one patients were included and 30 underwent sleeve implantation. Eleven patients served as a diet control group. All patients followed the same low-calorie diet during the study period. The purpose of the study was to determine the safety and efficacy of the device. Results:Twenty-six devices were successfully implanted. In 4 patients, implantation could not be achieved. Four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1). The remaining patients all completed the study. Mean procedure time was 35 minutes (range: 12–102 minutes) for a successful implantation and 17 minutes (range: 5–99 minutes) for explantation. There were no procedure related adverse events. During the study period the 26 duodenal-jejunal bypass sleeve patients (100%) had at least one adverse event, mainly abdominal pain and nausea during the first week after implantation. Initial mean body mass index (BMI, kg/m2) was 48.9 and 47.4 kg/m2 for the device and control patients, respectively. Mean excess weight loss after 3 months was 19.0% for device patients versus 6.9% for control patients (P < 0.002). Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m2, respectively. Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period (lower glucose levels, HbA1c, and medication requirements). Conclusion:The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results. The device also has a significant positive effect on type 2 diabetes mellitus. Long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.This study was registered at www.clinicaltrials.gov (registration number: NCT00830440).

Influence of phenotype at diagnosis and of other potential prognostic factors on the course of inflammatory bowel disease.

OBJECTIVES:Disease course in inflammatory bowel disease (IBD) is variable and difficult to predict. To optimize prognosis, it is of interest to identify phenotypic characteristics at disease onset and other prognostic factors that predict disease course. The aim of this study was to evaluate such factors in a population-based IBD group.METHODS:IBD patients diagnosed between 1 January 1991 and 1 January 2003 were included. A follow-up questionnaire was developed and medical records were reviewed. Patients were classified according to phenotype at diagnosis and risk factors were registered. Disease severity, cumulative medication use, and “surgical” and “nonsurgical” recurrence rates were calculated as outcome parameters.RESULTS:In total, 476 Crohns disease (CD), 630 ulcerative colitis (UC), and 81 indeterminate colitis (IC) patients were diagnosed. In CD (mean follow-up 7.6 years), 50% had undergone resective surgery. In UC (mean follow-up 7 years), colectomy rate was 8.3%. First year cumulative recurrence rates per 100 patient-years for CD, UC, and IC were 53, 44, and 42%, respectively. In CD, small bowel localization and stricturing disease were negative prognostic factors for surgery, as was young age. Overall recurrence rate was increased by young age and current smoking. In UC, extensive colitis increased surgical risk. In UC, older age at diagnosis initially increased recurrence risk but was subsequently protective.CONCLUSIONS:This population-based IBD study showed high recurrence rates in the first year. In CD, small bowel localization, stricturing disease, and young age were predictive for disease recurrence. In UC, extensive colitis and older age at diagnosis were negative prognostic predictors.

Fatigue and health-related quality of life in inflammatory bowel disease: results from a population-based study in the Netherlands: the IBD-South Limburg cohort.

Background: The importance of fatigue in chronic disease has been increasingly recognized; however, little is known about fatigue in inflammatory bowel disease (IBD). The aim of the present study was to investigate the prevalence and severity of fatigue and the impact on health‐related quality of life (HRQoL) in patients included in a population‐based IBD cohort in the Netherlands. Methods: IBD patients, diagnosed between January 1st, 1991, and January 1st, 2003, were followed up for a median of 7.1 years. They completed a questionnaire, which included a disease activity score, the Multidimensional Fatigue Inventory (MFI‐20), the Inflammatory Bowel Disease Questionnaire (IBDQ), and the Short Form health survey (SF‐36). Hemoglobin levels were recorded. Results: Data were available in 304 Crohns disease (CD), 368 ulcerative colitis (UC), and 35 indeterminate colitis (IC) patients. During quiescent disease, the prevalence of fatigue was nearly 40%. MFI‐20 and HRQoL scores were significantly worse in IBD patients having active disease. In a multivariate analysis, disease activity was positively related with the level of fatigue in both CD and UC. In UC, anemia influenced the general fatigue score independently of disease activity. Disease activity as well as fatigue were independently associated with an impaired IBDQ. Conclusions: In IBD, even in remission, fatigue is an important feature. Both in CD and in UC, fatigue determined HRQoL independently of disease activity or anemia. This implies that in IBD patients physicians need to be aware of fatigue in order to better understand its impact and to improve the HRQoL. (Inflamm Bowel Dis 2010)

Serum chromogranin A as a screening test for gastric enterochromaffin-like cell hyperplasia during acid-suppressive therapy.

Background Serum chromogranin A (CgA), a marker of neuroendocrine neoplasia, increases during profound gastric acid inhibition, possibly reflecting the trophic effect of gastrin on the enterochromaffin‐like (ECL) cells.

Non‐Helicobacter pylori bacterial flora during acid‐suppressive therapy: differential findings in gastric juice and gastric mucosa

Intragastric growth of non‐Helicobacter pylori bacteria commonly occurs during acid‐suppressive therapy. The long‐term clinical consequences are still unclear.

Serum gastrin and chromogranin A during medium‐ and long‐term acid suppressive therapy: a case‐control study

Serum chromogranin A (CgA) is regarded as a reliable marker of neuroendocrine proliferation. We previously described increased serum CgA levels during short‐term profound gastric acid inhibition.

In Vivo Diagnosis and Classification of Colorectal Neoplasia by Chromoendoscopy-Guided Confocal Laser Endomicroscopy

BACKGROUND & AIMS Colorectal cancer surveillance guidelines rely on clinicohistologic features of adenomas. Unfortunately, in common practice, recording of these features lacks precision and uniformity, which might hamper appropriate follow-up decisions. Confocal laser endomicroscopy (CLE) is a novel technology that allows real-time in vivo microscopy of the mucosa and provides accurate histopathology. The aims of this study were (1) to define and validate differential features of adenomatous and nonadenomatous colorectal polyps by chromoendoscopy-guided CLE (C-CLE) and (2) to assess predictive value of this technique for diagnosis of colorectal neoplasia. METHODS Patients at risk for colorectal cancer were prospectively investigated by using CLE. During extubation, fluorescein 10% was used in conjunction with acriflavine hydrochloride 0.05% to characterize global tissue architecture as well as cytonuclear features of colorectal epithelium. Ex vivo histology was used as gold standard. Reproducibility tests were performed. RESULTS In total, 116 colorectal polyps from 72 patients were examined. Ex vivo histology showed 68 adenomas, 6 invasive carcinomas, 30 hyperplastic polyps, and 12 inflammatory polyps. C-CLE of adenomas revealed lack of epithelial surface maturation, crypt budding, altered vascular pattern, and loss of cell polarity. In contrast, C-CLE of nonadenomatous polyps revealed epithelial surface maturation, and minor abnormalities of crypt architecture and of vascular pattern, and maintained cell polarity. Adenoma dysplasia score reliably discriminated high-grade dysplasia from low-grade dysplasia (accuracy, 96.7%). Interobserver agreement was high (K coefficients: pathologist, 0.92; endomicroscopist, 0.88). In vivo histology predicted ex vivo data with sensitivity of 97.3%, specificity of 92.8%, and accuracy of 95.7%. CONCLUSIONS C-CLE accurately discriminates adenomatous from nonadenomatous colorectal polyps and enables evaluation of degree of dysplasia during ongoing endoscopy. This technology might offer considerable potential to ultimately fine-tune surveillance programs, particularly in high-risk groups.

Double gastric infection with Helicobacter pylori and non-Helicobacter pylori bacteria during acid-suppressive therapy: increase of pro-inflammatory cytokines and development of atrophic gastritis.

Long‐term acid suppression may accelerate the development of atrophic gastritis in Helicobacter pylori‐positive subjects. The pathogenetic mechanism remains unclear.

Inflammatory Bowel Disease in South Limburg (the Netherlands) 1991–2002: Incidence, diagnostic delay, and seasonal variations in onset of symptoms

BACKGROUND AND AIMS Increasing incidence in Inflammatory Bowel Disease (IBD) has been suggested. Recent data on population based incidence rates within Europe are however scarce. Primary aim was to investigate prospectively the incidence of IBD within a well-defined geographical and administrative area of the Netherlands, the South Limburg IBD registry. Secondary aims were to study the duration of symptoms before diagnosis (lag time) and seasonal influences on the incidence of IBD. METHODS The incidence was examined using standardized registration of all newly diagnosed IBD patients, between 1-1-1991 and 1-1-2003. Medical records were reviewed to verify the diagnosis. At inclusion, diagnostic lag time was registered in months. RESULTS Age standardized incidence rates per 100,000 person-years (p-y) were: Crohns Disease, male 4.84, female 7.58; Ulcerative Colitis, male 8.51, female 6.92; and Indeterminate Colitis, male 1.05, female 0.93. Incidence rates did not significantly changes over time in either Crohns Disease, Ulcerative Colitis or Indeterminate Colitis. Lag time was 5 (0-360) months in Crohns Disease, 3.0 (0-480) months in Ulcerative Colitis and 3.0 (0-180) months in Indeterminate Colitis. Lag time was not significantly different between the periods 1991-1993 and 2000-2002, and no statistical differences in the onset of symptoms per calendar month or season were found. CONCLUSIONS Our results, from the South Limburg region (the Netherlands), show no significant change in incidence rates of IBD. The incidence found is relatively high compared to other European countries. Lag time did not change during the study period, and seasonal influence of incidence rates could not be confirmed.

Mortality in inflammatory bowel disease in the Netherlands 1991-2002: results of a population-based study: the IBD South-Limburg cohort.

Background: The aim was to evaluate overall and disease‐specific mortality in a population‐based inflammatory bowel disease (IBD) cohort in the Netherlands, as well as risk factors for mortality. Methods: IBD patients diagnosed between 1 January 1991 and 1 January 2003 were included. Standardized mortality ratios (SMRs) were calculated overall and with regard to causes of death, gender, as well as age, phenotype, smoking status at diagnosis, and medication use. Results: At the censoring date, 72 out of 1187 patients had died (21 Crohns disease [CD], 47 ulcerative colitis [UC], and 4 indeterminate colitis [IC] patients). The SMR (95% confidence interval [CI]) was 1.1 (0.7–1.6) for CD, 0.9 (0.7–1.2) for UC and 0.7 (0.2–1.7) for IC. Disease‐specific mortality risk was significantly increased for gastrointestinal (GI) causes of death both in CD (SMR 7.5, 95% CI: 2.8–16.4) and UC (SMR 3.4, 95% CI: 1.4–7.0); in CD patients, especially in patients <40 years of age at diagnosis. For UC, an increased SMR was noted in female patients and in patients <19 years and >80 years at diagnosis. In contrast, UC patients had a decreased mortality risk from cancer (SMR 0.5, 95% CI; 0.2–0.9). Conclusions: In this population‐based IBD study, mortality in CD, UC, and IC was comparable to the background population. The increased mortality risk for GI causes might reflect complicated disease course, with young and elderly patients at diagnosis needing intensive follow‐up. Caution in interpreting the finding on mortality risk from cancer is needed as follow‐up was probably to short to observe IBD‐related cancers. (Inflamm Bowel Dis 2010)