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1.  Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease 
AIM: To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease (GERD).
METHODS: After unblinding and crossover, 50 patients (32 males, 18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized, placebo-controlled, single-center study, and included in the present prospective open-label follow-up study. Initially, three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner. Optional retreatment was offered in the first year with 1 or 2 extra gastroplications. At baseline, 3 mo after (re) treatment and yearly proton pump inhibitor (PPI) use, GERD symptoms, quality of life (QoL) scores, adverse events and treatment failures (defined as: patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed. Intention-to-treat analysis was performed.
RESULTS: Median follow-up was 48 mo [interquartile range (IQR): 38-52]. Three patients were lost to follow-up. In 44% of patients retreatment was done after a median of 4 mo (IQR: 3-8). No serious adverse events occurred. At the end of follow-up, symptom scores and 4 out of 6 QoL subscales were improved (all P < 0.01 compared to baseline). However, 80% of patients required PPIs for their GERD symptoms. Ultimately, 64% of patients were classified as treatment failures. In 60% a post-procedural endoscopy was carried out, of which in 16% reflux esophagitis was diagnosed.
CONCLUSION: In the 4-year follow-up period, the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually, nearly half opted for retreatment and 80% required PPIs eventually.
PMCID: PMC3817287  PMID: 24199028
Endoscopic therapy; Endocinch; Gastroesophageal Reflux; Gastroplication; Follow-up studies
2.  Author's response 
Gut  2007;56(7):1027.
PMCID: PMC1994339
3.  C-reactive protein levels during a relapse of Crohn’s disease are associated with the clinical course of the disease 
AIM: To explore if C-reactive protein (CRP) levels might serve as a prognostic factor with respect to the clinical course of Crohn’s disease and might be useful for classification.
METHODS: In this retrospective cohort study we enrolled 94 patients from the inflammatory bowel disease (IBD) database of the University Medical Centre Utrecht. CRP levels during relapse were correlated with the number of relapses per year. Severity of relapses was based on endoscopic reports and prednisone use. Furthermore, patients were categorized in a low or high CRP group based on their CRP response during relapse and demographic and clinical features were compared.
RESULTS: Overall, a positive correlation between CRP levels, number of relapses, and severity of relapse was found (respectively rs = 0.31, P < 0.01 and rs = 0.50, P < 0.001). Employing a cut-off level of 15 mg/L, the index CRP level was found to discriminate patients with respect to the number of relapses per year, as well as for severity of relapses (respectively 0.25 ± 0.16 vs 0.36 ± 0.24, P < 0.05 and 4.4 ± 1.2 vs 3.2 ± 1.1 on a 10-point visual analogue scale, P < 0.001 for the high CRP and low CRP groups respectively). In addition, the high CRP group showed more cumulative days of prednisone use per year (107 ± 95 vs 58 ± 48, P < 0.05), as well as a better response to infliximab (93 % vs 33 %, P = 0.06).
CONCLUSION: A higher CRP level during relapse seems to be associated with a more severe clinical course of disease.
PMCID: PMC2673397  PMID: 18176967
Crohn’s disease; Infliximab; C-reactive protein; Prognosis; Clinical behaviour
4.  Performance of EUS-FNA for mediastinal lymphadenopathy: impact on patient management and costs in low-volume EUS centers 
Surgical Endoscopy  2010;24(9):2260-2267.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of mediastinal lymphadenopathy has been shown to be a valuable diagnostic tool in high-volume EUS centers (≥50 mediastinal EUS-FNA/endoscopist/year). Our goal was to assess the diagnostic accuracy of EUS-FNA and its impact on clinical management and costs in low-volume EUS centers (<50 mediastinal EUS-FNA/endoscopist/year).
Consecutive patients referred to two Dutch endoscopy centers in the period 2002–2008 for EUS-FNA of mediastinal lymphadenopathy were reviewed. The gold standard for a cytological diagnosis was histological confirmation or clinical follow-up of more than 6 months with repeat imaging. The impact of EUS-FNA on clinical management was subdivided into a positive impact by providing (1) adequate cytology that influenced the decision to perform surgery or (2) a diagnosis of a benign inflammatory disorder, and a negative impact which was subdivided into (1) false-negative or inconclusive cytology or (2) an adequate cytological diagnosis that did not influence patient management. Costs of an alternative diagnostic work-up without EUS-FNA, as established by an expert panel, were compared to costs of the actual work-up.
In total, 213 patients (71% male, median age = 61 years, range = 23–88 years) underwent EUS-FNA. Sensitivity, specificity, and negative and positive predictive values were 89%, 100%, 80%, and 100%, respectively. EUS-FNA had a positive impact on clinical management in 84% of cases by either influencing the decision to perform surgery (49%) or excluding malignant lymphadenopathy (35%), and a negative impact in 7% of cases because of inadequate (3%) or false-negative (4%) cytology. In 9% of cases, EUS-FNA was performed without an established indication. Two nonfatal perforations occurred (0.9%). Total cost reduction was €100,593, with a mean cost reduction of €472 (SD = €607) per patient.
Mediastinal EUS-FNA can be performed in low-volume EUS centers without compromising diagnostic accuracy. Moreover, EUS-FNA plays an important role in the management of patients with mediastinal lymphadenopathy and reduces total diagnostic costs.
PMCID: PMC2939341  PMID: 20177920
EUS-FNA; Costs; Accuracy; Mediastinal lymphadenopathy
5.  Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) 
BMC Surgery  2009;9:4.
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
( NTR1422
PMCID: PMC2664790  PMID: 19284647

Results 1-5 (5)