Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications.

OBJECTIVES: Sedation has been established for GI endoscopic procedures in most countries, but it is also associated with an added risk of complications. Reported complication rates are variable due to different study methodologies and often limited sample size. DESIGNS: Acute sedation-associated complications were prospectively recorded in an electronic endoscopy documentation in 39 study centres between December 2011 and August 2014 (median inclusion period 24 months). The sedation regimen was decided by each study centre. RESULTS: A total of 368 206 endoscopies was recorded; 11% without sedation. Propofol was the dominant drug used (62% only, 22.5% in combination with midazolam). Of the sedated patients, 38 (0.01%) suffered a major complication, and overall mortality was 0.005% (n=15); minor complications occurred in 0.3%. Multivariate analysis showed the following independent risk factors for all complications: American Society of Anesthesiologists class >2 (OR 2.29) and type and duration of endoscopy. Of the sedation regimens, propofol monosedation had the lowest rate (OR 0.75) compared with midazolam (reference) and combinations (OR 1.0-1.5). Compared with primary care hospitals, tertiary referral centres had higher complication rates (OR 1.61). Notably, compared with sedation by a two-person endoscopy team (endoscopist/assistant; 53.5% of all procedures), adding another person for sedation (nurse, physician) was associated with higher complication rates (ORs 1.40-4.46), probably due to higher complexity of procedures not evident in the multivariate analysis. CONCLUSIONS: This large multicentre registry study confirmed that severe acute sedation-related complications are rare during GI endoscopy with a very low mortality. The data are useful for planning risk factor-adapted sedation management to further prevent sedation-associated complications in selected patients. TRIAL REGISTRATION NUMBER: DRKS00007768; Pre-results.

Subjective and objective olfactory abnormalities in Crohn's disease.

The pathogenesis of Crohn's disease (CD) is still unknown, but the involvement of the olfactory system in CD appears possible. No study to date has systematically assessed the olfactory function in CD patients. We investigated the olfactory function in CD patients in active (n = 31) and inactive disease (n = 27) and in a control group of age- and sex-matched healthy subjects (n = 35). Subjective olfactory testing was applied using the Sniffin' Sticks test. For olfactory testing, olfactory event-related potentials (OERPs) were obtained with a 4-channel olfactometer using phenyl ethyl alcohol (PEA) and hydrogen sulfide (H(2)S). Carbon dioxide (CO(2)) was employed as control stimulus, and chemosomatosensory event-related potentials (CSSERPs) were registered. Results of the Sniffin' Sticks test revealed significantly different olfactory hedonic judgment with increased olfactory hedonic estimates for pleasant odorants in CD patients in active disease compared with healthy subjects. A statistical trend was found toward lower olfactory thresholds in CD patients. In objective olfactory testing, CD patients showed lower amplitudes of OERPs and CSSERPs. Additionally, OERPs showed significantly shorter N1- and P2 latencies following stimulation of the right nostril with H(2)S in CD patients in inactive disease compared with controls. Our study demonstrates specific abnormalities of olfactory perception in CD patients.

Hemodynamic efficacy of sequential hemoclip application using the Olympus HX-110/610 reloadable clipping device in spurting bleedings.

BACKGROUND: Hemoclip application in GI-hemorrhage has proven to be effective. Clinical experience shows that multiple clips are frequently necessary. In 2005, an easily reloadable clip-applicator was introduced. We evaluated the hemodynamic efficacy of this new device. MATERIAL/METHODS: We prospectively compared the new clipping device (Olympus HX 110/610) in a validated experimental setting using the compactEASIE®-simulator for GI bleeding. The artificial blood circulation system in the simulator was connected to a pressure transducer. Four investigators of different endoscopic experience (1000-6000 endoscopies) treated 12 bleeding sources each, with up to 6 clips for each bleeding location. Pressures were recorded to objectify the additive effects of sequential clip application on the reduction in vessel diameter. The intervention was abandoned if a maximum measurable pressure of 300 mmHg was achieved. RESULTS: Hemoclip application led to a significant increase of peak pressure (91±100 mmHg, p<0.001) and mean pressure (95±99 mmHg, p<0.001), representing a significant reduction in vessel diameter. Pooled data showed a significant stepwise increase in mean and maximum system pressure, resulting in reduction of vessel diameter up to the fifth hemoclip. On average, 5 clips (range 1-6) were used. More experienced endoscopists achieved a higher increase in mean pressure (167 and 118 mmHg vs 72 and 23 mmHg, p<0.05). Mean reloading time was 39 seconds (19-49 sec). CONCLUSIONS: Sequential application of multiple hemoclips led to an increasing effect, comparable to the results of previous clinical trials. The number of hemoclips applied correlated inversely, but not significantly, with the endoscopist´s experience. Expensive single-use clips appear dispensable in view of the short reloading time.

Alterations of taste perception in Crohn's disease and their dependency on disease activity and nutritional behavior.

BACKGROUND: The pathogenesis of Crohn's disease (CD) is unknown. Besides immunoregulatory, genetic and environmental aspects, a nutritional impact is also encountered. Whether taste perception exerts any influence on an increased consumption of carbohydrates is unknown. OBJECTIVE: To evaluate nutritional habits and taste perception in CD patients, either in active or inactive disease stages. DESIGN: A prospective study was performed with 31 active and 27 inactive CD patients, and 30 age and sex-matched healthy subjects. Nutritional behavior was determined using an extensive optical nutrition questionnaire and taste perception was assessed by a 3-drop method with exceeding dilution tests. RESULTS: Active and inactive CD patients exhibited a significant increased taste threshold for the detection of all solutions (bitter: P=0.0012; salty: P=0.0198; sour: P=0.0021; and sweet: P=0.0208). For recognition, the determination of bitter solution (P=0.0014) was significantly reduced in CD patients compared with healthy subjects. No impact of clinical or objective parameters of inflammation on taste perception could be established. The consumption of refined sugar in CD patients was higher than in healthy subjects, though not significant. CONCLUSIONS: An increased taste threshold for the detection of all 4 taste qualities in active and inactive CD patients suggests a systemic pathogenesis, such as an inflammation of the oral cavity, as a manifestation of CD. In this study, changes in taste threshold were not associated with altered sugar consumption.

Chemoradiation may prolong survival of patients with non-bulky unresectable extrahepatic biliary carcinoma. A retrospective analysis.

PURPOSE: . This study compared stenting and chemoradiation (CRT) and attempted to identify factors that are predictive of response to CRT. MATERIAL AND METHODS: . A retrospective analysis identified 98 patients treated. The primary tumor and lymphatics received 45 Gy of three-dimensional conformal radiotherapy. Tumors were boosted to a median total dose of 50.8 Gy. Simultaneous chemotherapy was 5-fluorouracil- (5-FU) and gemcitabine-based. RTOG/NCI-CTC toxicity criteria were applied. RESULTS: . Median survival time was 11.8 months for all patients, 9.3 months for patients with stenting alone and 16.5 months with CRT (p = 0.22). Only tumor diameter was predictive of survival for treatment with CRT. A threshold of 40 mm at diagnosis distinguished two survival profiles (21.4 vs. 8.7 months; p = 0.01). Toxicity was lower for 5-FU-based CRT compared to gemcitabinebased CRT, but a safe schedule for gemcitabine-based CRT was identified. Two patients (2/25) with unresectable tumors at diagnosis had pathohistological complete response at resection after CRT. CONCLUSION: . Inclusion criteria for future CRT trials should be based on tumor size at diagnosis: patients otherwise eligible for CRT should only be included with an inoperable tumor

Predictive factors of mortality after PEG insertion: guidance for clinical practice.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is considered the preferred route for long-term enteral feeding. The aim of this study was to determine predictors of an increased mortality risk after PEG insertion. METHODS: A retrospective study was conducted during a 13-year period in the gastroenterology department of Erlangen University Hospital. The authors completed a questionnaire with details of demographic data, diagnosis, indication for PEG, type of tube, and cause of death. Patients were contacted regularly at scheduled appointments. RESULTS: In total, 787 patients (574 male [72.9%]) underwent PEG placement by the pull technique. The main underlying disease was malignant (75.6%). By the end of the study period, 614 patients had died. The average survival time was 720 days. The 30-, 60-, 90-day and 1-, 3-, and 5-year mortality rates amounted to 6.5%, 9.8%, 13%, 32.1%, 59.3%, and 69.8%, respectively. Predictive factors of increased 30-day mortality were higher age, lower body mass index (BMI), and the presence of diabetes mellitus. The presence of all 3 variables served as an indicator to detect high-risk patients, with a sensitivity of 0.80 and a specificity of 0.64. CONCLUSION: Mortality predictors for patients after PEG insertion are higher age, lower BMI, and the presence of diabetes mellitus. To avoid unnecessary and dangerous examinations in high-risk patients, the above-mentioned predictive factors of mortality should be checked before PEG placement.

Evaluation of sensitivity and inter- and intra-observer variability in the detection of intestinal metaplasia and dysplasia in Barrett's esophagus with enhanced magnification endoscopy.

OBJECTIVE: Magnification endoscopy with acetic acid or dye for diagnosis of Barrett's esophagus is presently undergoing clinical evaluation. Current studies report good accuracy in predicting specialized intestinal metaplasia. To date, however, there is no definitive information on the inter- and intra-observer variability of these methods applied to the diagnosis of normal and dysplastic Barrett's mucosa. MATERIAL AND METHODS: Sixty patients with endoscopically suspected Barrett's esophagus were investigated prospectively with the zoom endoscope after contrast enhancement of the mucosa with 1.5% acetic acid. Two hundred and twenty-three enlarged and histologically investigated areas of gastric, cardiac, normal and dysplastic Barrett's mucosa were photodocumented and in randomized sequence presented to 4 endoscopists in a blinded manner (2 with and 2 without experience of zoom endoscopy for evaluation). The reference for the first evaluation (A1) was standard endoscopic photographs of the respective, histologically confirmed mucosal entity. In a second evaluation (A2), the pictures were again interpreted by the same blinded investigators, but this time a modified pit-pattern classification as proposed by Sharma et al. was employed as the evaluation reference. RESULTS: The diagnostic sensitivity for specialized intestinal metaplasia and dysplasia in Barrett's esophagus calculated for the A1 evaluation ranged -- investigator dependently -- from 54.9% to 80.7% and for A2 from 42.2% to 81.5%. The inter- and intra-observer variability for the evaluation procedure A1 and A2 was high (all kappa values <0.4). In particular, the inexperienced investigators demonstrated high intra-observer variability and low sensitivity in comparison with the experienced investigators. CONCLUSIONS: The diagnosis of Barrett's mucosa using enhanced magnification endoscopy after acetic acid instillation is associated with a high level of interobserver variability. One reason is a frequent mismatch between cardiac mucosa and non-dysplastic Barrett's mucosa.

Endoscopic placement of nasojejunal tubes: a randomized, controlled, prospective trial comparing suitability and technical success for two different tubes.

BACKGROUND: Jejunal feeding is an attractive means for delivering nutrients to critically ill patients. Nasojejunal tubes may have different advantages and disadvantages that may have important clinical implications. METHODS: To compare the suitability of 2 different nasojejunal feeding tubes (Tube A, Dobbhoff; Tube B, Freka-Trelumina) for use by endoscopists and nursing staff, a randomized, controlled, prospective trial was performed in 60 patients. The primary end point was time required for tube placement. Secondary end points were successful placement and nursing problems encountered during clinical use. Results of upper endoscopy were also recorded. RESULTS: Placement took significantly longer with Tube A than Tube B (95% CI for median [11.5, 20.0] minutes vs. [5.5, 7.5] minutes; p < 0.001), and was less successful (73.3% vs. 90%; p = 0.18). Nursing problems occurred significantly more often with Tube A compared with Tube B (11 vs. 1; p < 0.001). Tube B stayed in place significantly longer than Tube A (37 days vs. 21 days; p = 0.034). In 45% of the cases, upper endoscopy provided a diagnosis of potential therapeutic relevance. CONCLUSIONS: Selection of a nasojejunal tube for endoscopic placement has significant implications with respect to time required for placement, duration of tube usage and the practicability for nursing staff. Diagnostic upper endoscopy performed concomitantly often reveals findings of clinical importance.

Functional and morphologic characterization of eosinophils in the lower intestinal mucosa of patients with food allergy.

OBJECTIVE: The aim of this study was to characterize the functional and morphologic features of eosinophils in the intestinal mucosa of patients with food allergy. METHODS: Eighteen patients with food allergy and 11 controls took part in this study. In every patient, corresponding biopsy samples obtained during colonoscopy were quantitatively assessed by immunohistochemical methods (EPO-I) and subjected to mucosa oxygenation using eosinophilic cationic protein (ECP). Initial basal release, spontaneous and anti-IgE-dependent release, and the total ECP content of mucosal biopsies were studied. RESULTS: Morphologically, mucosal eosinophils in patients with food allergy have distinct features, occur in larger amounts, and show a distinct distribution pattern (i.e., intraepithelial, lamina propria, and submucosa). Their initial basal release is similar to that of controls, but stimulation of the IgE receptor with anti-IgE results in 40-fold activation (p < 0.001). In food allergy patients, the density of eosinophils, the presence of intraepithelial eosinophils, and the rate of degranulation showed a highly significant correlation to the initial basal release of ECP by mucosal tissue (Kendall tau = 0.619, 0.381, and 0.609, respectively; p < 0.05 for all) but not to their capability to be stimulated with anti-IgE. CONCLUSIONS: Eosinophils of the lower intestine of patients with food allergy show characteristic features with regard to morphology, distribution, and functional behavior to IgE receptor stimulation. Immunostaining of eosinophil peroxidase (EPO) detects important characteristic features that are missed with conventional hematoxylin-eosin staining.