Patients' treatment limitations as predictive factor for mortality in COVID-19: results from hospitalized patients of a hotspot region for SARS-CoV-2 infections.

BACKGROUND: In hospitalized patients with SARS-CoV-2 infection, outcomes markedly differ between locations, regions and countries. One possible cause for these variations in outcomes could be differences in patient treatment limitations (PTL) in different locations. We thus studied their role as predictor for mortality in a population of hospitalized patients with COVID-19. METHODS: In a region with high incidence of SARS-CoV-2 infection, adult hospitalized patients with PCR-confirmed SARS-CoV-2 infection were prospectively registered and characterized regarding sex, age, vital signs, symptoms, comorbidities (including Charlson comorbidity index (CCI)), transcutaneous pulse oximetry (SpO2) and laboratory values upon admission, as well as ICU-stay including respiratory support, discharge, transfer to another hospital and death. PTL assessed by routine clinical procedures comprised the acceptance of ICU-therapy, orotracheal intubation and/or cardiopulmonary resuscitation. RESULTS: Among 526 patients included (median [quartiles] age 73 [57; 82] years, 47% female), 226 (43%) had at least one treatment limitation. Each limitation was associated with age, dementia and eGFR (p < 0.05 each), that regarding resuscitation additionally with Charlson comorbidity index (CCI) and cardiac disease. Overall mortality was 27% and lower (p < 0.001) in patients without treatment limitation (12%) compared to those with any limitation (47%). In univariate analyses, age and comorbidities (diabetes, cardiac, cerebrovascular, renal, hepatic, malignant disease, dementia), SpO2, hemoglobin, leucocyte numbers, estimated glomerular filtration rate (eGFR), C-reactive protein (CRP), Interleukin-6 and LDH were predictive for death (p < 0.05 each). In multivariate analyses, the presence of any treatment limitation was an independent predictor of death (OR 4.34, 95%-CI 2.10-12.30; p = 0.001), in addition to CCI, eGFR < 55 ml/min, neutrophil number > 5 G/l, CRP > 7 mg/l and SpO2 < 93% (p < 0.05 each). CONCLUSION: In hospitalized patients with SARS-CoV-2, the percentage of patients with treatment limitations was high. PTL were linked to age, comorbidities and eGFR assessed upon admission and strong, independent risk factors for mortality. These findings might be useful for further understanding of COVID-19 mortality and its regional variations. Clinical trial registration ClinicalTrials.gov Identifier: NCT04344171.

Colon diverticulosis is not a risk factor for the detection of adenomatous polyps - results of a prospective study.

BACKGROUND AND AIMS: Colon diverticula (CD) and adenomatous polyps are frequently found during colonoscopy. Data from the literature contains inconsistent information about whether patients with CD have a higher risk for colon adenomas. A positive correlation might influence the current guidelines for screening colonoscopies. The aim of this study was to examine whether presence of CD is associated with endoscopic adenoma detection. MATERIALS AND METHODS: This was a prospective study at 2 centers in Germany. Patients with an indication for colonoscopy were included. The number and localization of diverticula were recorded. Detected polyps were resected, and histopathological results were captured. Logistic regression models were fitted to the data to evaluate the association between CD and adenoma detection. RESULTS: A total of 938 colonoscopies was included. CD occurred in 49.1 % of the colonoscopies. The polyp and adenoma detection rates (PDR, ADR) were 50.3 % and 32.3 %. In 37.5 % of the patients with diverticula, at least 1 adenoma was detected, whereas this was the case in 27.3 % in the absence of diverticula. The presence of diverticula was positively correlated with the detection of adenomas in univariate analysis (p = 0.001), but no significant association could be found in multivariable analysis (p = 0.775). Increasing age (p < 0.001), male sex (p = 0.005), and longer withdrawal time (p < 0.001) were significant predictors for adenoma detection in the multivariable analysis. Similar results were also observed for both the distal and the proximal colon. DISCUSSION: Diverticula and adenomas are frequently found during colonoscopies. However, diverticula disease was not significantly associated with adenoma detection after adjustment for relevant prognostic factors. Older age, male sex, and duration of withdrawal time are predictors for the detection of adenomatous polyps.

Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study.

BACKGROUND: Cap-assisted colonoscopy is frequently used to facilitate adenoma detection during endoscopy. However, data on how cap assistance influences polyp resection are scarce. We aimed to evaluate the impact of cap assistance with the Endocuff vision device (EVD) on the resection time for colorectal polyps in patients undergoing colonoscopy. METHODS : A randomized, prospective study was performed in a university hospital in Germany. A total of 250 patients were randomly assigned 1:1 to undergo either colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm). The primary outcome was the average duration of polypectomy. Secondary outcomes included adenoma detection rate, cecal and ileal intubation times, and propofol dosage. RESULTS: The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P = 0.02). This effect was strongest for polyps ≥ 6 mm. Compared with the standard group, Endocuff assistance also resulted in a shorter cecal intubation time (6 vs. 8 minutes; P = 0.03) and overall colonoscopy time (23 vs. 27 minutes; P = 0.02). In contrast, no difference in withdrawal time was observed. The polyp and adenoma detection rates did not differ significantly between the two groups. CONCLUSION: Endocuff-assisted colonoscopy reduces the duration of polypectomy, which may be due to a more stable scope position during resection. Further studies are needed to investigate whether comparable effects will be seen for other interventions, such as clipping or biopsy sampling.

Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers.

BACKGROUND & AIMS: Endoscopic hemostasis is effective in treatment of bleeding peptic ulcers. However, rebleeding is difficult to treat and associated with substantial morbidity and mortality. We performed a prospective randomized trial to determine whether over-the-scope clips (OTSCs) are more effective than standard treatment of severe recurrent upper gastrointestinal bleeding. METHODS: We performed our study at 9 academic referral centers (in Germany, Switzerland, and Hong Kong) from March 2013 through September 2016. Adult patients with recurrent peptic ulcer bleeding following initially successful hemostasis (66 patients in the intent-to-treat analysis) were randomly assigned to groups (1:1) that underwent hemostasis with either OTSC or standard therapy. Standard therapy was defined as hemostasis with through-the-scope clips (TTSC, n = 31) or thermal therapy plus injection with diluted adrenaline (n = 2). The primary endpoint was further bleeding (a composite endpoint of a persistent bleeding despite endoscopic therapy according to the protocol or recurrent bleeding within 7 days after successful hemostasis). Patients with further bleeding were allowed to cross over to OTSC therapy. Main secondary endpoints were mortality, necessity of surgical or angiographic salvage therapy, duration of stay in the hospital or intensive care, number of blood units transfused, and complications associated with endoscopic therapy. RESULTS: Persistent bleeding after per-protocol hemostasis was observed in 14 patients (42.4%) in the standard therapy group and 2 patients (6.0%) in the OTSC group (P = .001). Recurrent bleeding within 7 days occurred in 5 patients (16.1%) in the standard therapy group vs 3 patients (9.1%) in the OTSC group (P = .468). Further bleeding occurred in 19 patients (57.6%) in the standard therapy group and in 5 patients (15.2%) in the OTSC group (absolute difference 42.4%; 95% confidence interval 21.6-63.2; P = .001) Within 30 days of follow-up, 1 patient in the standard therapy group (3.0%) and 1 patient in the OTSC group (3.0%) required surgical therapy (P = .999). Within 30 days of the procedure, 2 patients died in the standard therapy group (6.3%) and 4 patients died in the OTSC group (12.1%) (P = .672). There were no significant differences in the other secondary endpoints. CONCLUSIONS: In prospective randomized trial, we found endoscopic treatment with OTSCs to be superior to standard therapy with TTSCs for patients with recurrent peptic ulcer bleeding. STING Study, Clinicaltrials.gov no: NCT1836900.

Automated polyp detection in the colorectum: a prospective study (with videos).

BACKGROUND AND AIMS: Adenoma detection is a highly personalized task that differs markedly among endoscopists. Technical advances are therefore desirable for the improvement of the adenoma detection rate (ADR). An automated computer-driven technology would offer the chance to objectively assess the presence of colorectal polyps during colonoscopy. We present here the application of a real-time automated polyp detection software (APDS) under routine colonoscopy conditions. METHODS: This was a prospective study at a university hospital in Germany. A prototype of a novel APDS ("KoloPol," Fraunhofer IIS, Erlangen, Germany) was used for automated image-based polyp detection. The software functions by highlighting structures of possible polyp lesions in a color-coded manner during real-time colonoscopy procedures. Testing the feasibility of APDS deployment under real-time conditions was the primary goal of the study. APDS polyp detection rates (PDRs) were defined as secondary endpoints provided that endoscopists' detection served as criterion standard. RESULTS: The APDS was applied in 55 routine colonoscopies without the occurrence of any clinically relevant adverse events. Endoscopists' PDRs and ADRs were 56.4% and 30.9%, respectively. The PDRs and ADRs of the APDS were 50.9% and 29.1%, respectively. The APDS detected 55 of 73 polyps (75.3%). Smaller polyp size and flat polyp morphology were correlated with insufficient polyp detection by the APDS. CONCLUSION: Computer-assisted automated low-delay polyp detection is feasible during real-time colonoscopy. Efforts should be undertaken to improve the APDS with respect to smaller and flat shaped polyps. (Clinical trial registration number: NCT02838888.).

Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II).

BACKGROUND AND AIMS: Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, the rates of inadequate preparation are still high. We investigated the effects of reinforcing patient education and guidance by using the short message service (SMS). METHODS: In this prospective, endoscopist-blinded, multicenter study, standard instructions pertaining to split-dose preparation were provided in a verbal and written format to all patients during the initial appointment. Patients were randomly assigned (1:1) to a group that received reinforced education starting 4 days before the colonoscopy (SMS group) or to the control group which did not receive further education. The primary outcome was the percentage of insufficient preparation results (Boston Bowel Preparation Scale [BBPS] score <6). The secondary outcomes included quality of bowel preparation according to the BBPS, polyp and adenoma detection rates, and patients' perceived discomfort in the preparation procedure. RESULTS: The percentage of patients with insufficient bowel preparation was significantly lower in the SMS group (9%) than in the control group (19%) (P = .0013). The mean BBPS score was significantly higher in the SMS group (7.4 ± 0.1) than in the control group (6.5 ± 0.1) (P < .0001). Each colon segment had significantly higher BBPS scores in the SMS group. The adenoma detection rate and number of detected adenomas in the right segment of the colon were higher in the SMS group. SMS messages were accompanied by a lower level of discomfort during preparation (numeric rating scale) (5.2 SMS vs 5.8 controls) (P = .0042). CONCLUSIONS: Reinforced patient education by using SMS messages during the 4 days before colonoscopy increased bowel cleanliness, adenoma detection in the right segment of the colon, and reduced discomfort. (Clinical trial registration number: NCT02272036.).

Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study.

BACKGROUND : Use of a side-viewing endoscope is currently mandatory to examine the major duodenal papilla; however, previous studies have used cap-assisted endoscopy for complete examination of the papilla. The aim of this study was to compare cap-assisted endoscopy with side-viewing endoscopy for examination of the major duodenal papilla. METHODS : This was a prospective, randomized, blinded, controlled, noninferiority crossover study. Patients were randomized to undergo either side-viewing endoscopy followed by cap-assisted endoscopy or cap-assisted endoscopy followed by side-viewing endoscope. Photographs of the major duodenal papilla were digitally edited to mask the cap area before they were evaluated by three blinded external examiners. Our primary end point was complete visualization of the major duodenal papilla. Secondary end points were the ability to examine the mucosal pattern, the overview of the periampullary region, overall satisfaction, and time to locate the papilla. RESULTS : 62 patients completed the study. Complete visualization of the major duodenal papilla was achieved in 60 examinations by side-viewing endoscopy and in 59 by cap-assisted endoscopy (97 % vs. 95 %). The difference between the two examinations was 1.6 % with a two-sided 95 % confidence interval of -4.0 % to 7.3 %, which did not exceed the noninferiority margin of 8 %. Cap-assisted endoscopy achieved better scores regarding the examination of mucosal pattern and overall satisfaction, whereas side-viewing endoscopy had a better overview score (P < 0.001, P = 0.004, and P < 0.001, respectively). There was no relevant difference in the median times to locate the major duodenal papilla. CONCLUSION : Cap-assisted endoscopy and side-viewing endoscopy had similar success rates for complete visualization of the major duodenal papilla. Cap-assisted endoscopy is superior to side-viewing endoscopy regarding the mucosal pattern and overall satisfaction. Side-viewing endoscopy gives a better overview of the periampullary region.

Near focus NBI endoscopy plus acetic acid for optical polyp characterization in the colorectum - A proof of principle study.

Background and study aim: Optical polyp characterization (OPC) in the colorectum is an upcoming challenge for endoscopists. Narrow band imanging (NBI) has been proposed to be helpful for OPC. However, data from clinical studies have shown that quality of OPC differs markedly between endoscopists. The aim of this study was to test the value of a combined NBI plus acetic acid (NBI + AA) approach for OPC in the colorectum. Patients and methods: This was a prospective, single-arm study at a tertiary referral center in Germany. The study was designed as a proof of principle study. Initially polyps were characterized using High-definition white light (HDWL) only. Additionally, the same polyps were investigated using NBI + AA (1.5% solution) in order to predict polyp pathology in a real time setting. The near focus function was used for both HDWL and NBI + AA assessment. The primary endpoint was accuracy of colorectal polyp prediction when using NBI + AA. Results: A total of 63 polyps were detected in 55 patients. NBI + AA based accuracy of real-time predictions was 85.5% compared to 80.6% using HDWL (p = .450). Accuracy was 90.2% in the high confidence setting for both NBI + AA and HDWL predictions. A higher share of polyps were assessed with high confidence when using NBI + AA compared to HDWL (p = .006). The use of NBI + AA led to a better identification of polyp margins (p < .001) compared to HDWL. Conclusions: The use of acetic acid led to a high level of accuracy and confidence in the prediction of polyp histology. These data justify further investigation in a randomized controlled study.

Comparison of Ultrasound and Fluoroscopically Guided Percutaneous Transhepatic Biliary Drainage.

BACKGROUND: Percutaneous transhepatic biliary drainage (PTBD) plays a significant role especially in the palliation of an endoscopically inaccessible biliary system. Since a standard technique of PTBD is not defined, we compared a fluoroscopically guided technique (F-PTBD) with an ultrasound (US-PTBD) guided approach. PATIENTS AND METHODS: Procedure characteristics, success-rates and complication-rates of the different PTBD techniques were compared in patients who underwent PTBD between October 1, 2006, and -December 31, 2014. RESULTS: In 195 patients, 251 PTBDs (207 F-PTBDs, 44 US-PTBDs) were performed. F-PTBDs were mostly inserted from the right and US-PTBDs from the left. Patient age, gender and physical status were comparable in both techniques. There was no difference regarding overall procedure success (90%/86.4%), overall interventional complication rates (10.6%/9.1%), fluoroscopy times, intervention times or sedatives dosages. However, major complications were only encountered in F-PTBDs. There was a higher success rate for F-PTBD vs. US-PTBD from the right side (91.9 vs. 75%; p = 0.033) and a trend towards a higher success rate for US guidance from the left side (82.9 vs. 95.8%; p = 0.223). CONCLUSIONS: For drainage of the right biliary system F-PTBD seems superior over the US-PTBD technique used in this study. However, major complications can occur more frequently in F-PTBD.

Optical classification of neoplastic colorectal polyps - a computer-assisted approach (the COACH study).

BACKGROUND AND AIMS: Clinical data suggest that the quality of optical diagnoses of colorectal polyps differs markedly among endoscopists. The aim of this study was to develop a computer program that was able to differentiate neoplastic from non-neoplastic polyps using unmagnified endoscopic pictures. METHODS: During colonoscopy procedures polyp photographies were performed using the unmagnified high-definition white light and narrow band image mode. All detected polyps (n = 275) were resected and sent to pathology. Histopathological diagnoses served as the ground truth. Machine learning was used in order to generate a computer-assisted optical biopsy (CAOB) approach. In the test phase pictures were presented to CAOB in order to obtain optical diagnoses. Altogether 788 pictures were available (602 for training the machine learning algorithm and 186 for CAOB testing). All test pictures were also presented to two experts in optical polyp characterization. The primary endpoint of the study was the accuracy of CAOB diagnoses in the test phase. RESULTS: A total of 100 polyps (of these 52% neoplastic) were used in the CAOB test phase. The mean size of test polyps was 4 mm. Accuracy of the CAOB approach was 78.0%. Sensitivity and negative predictive value were 92.3% and 88.2%, respectively. Accuracy obtained by two expert endoscopists was 84.0% and 77.0%. Regarding accuracy of optical diagnoses CAOB predictions did not differ significantly compared to experts (p = .307 and p = 1.000, respectively). CONCLUSIONS: CAOB showed good accuracy on the basis of unmagnified endoscopic pictures. Performance of CAOB predictions did not differ significantly from experts' decisions. The concept of computer assistance for colorectal polyp characterization needs to evolve towards a real-time application prior of being used in a broader set-up.

Management of occluded self-expanding biliary metal stents in malignant biliary disease.

BACKGROUND: Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. METHODS: Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. RESULTS: A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). CONCLUSIONS: In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management strategy.

Cap Assisted Upper Endoscopy for Examination of the Major Duodenal Papilla: A Randomized, Blinded, Controlled Crossover Study (CAPPA Study).

OBJECTIVE: Examination of major duodenal papilla (MDP) by standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Cap assisted esophagogastroduodenoscopy (CA-EGD) utilizes a cap fitted to the tip of the endoscope that can depress the mucosal folds and thus might improve visualization of MDP. The aim of this study was to compare CA-EGD to S-EGD for complete examination of the MDP. METHODS: Prospective, randomized, blinded, controlled crossover study. Subjects scheduled for elective EGD were randomized to undergo S-EGD (group A) or CA-EGD (group B) before undergoing a second examination by the alternate method. Images of the MDP were evaluated by three blinded multicenter-experts. Our primary outcome measure was complete examination of the papilla. Secondary outcome measures were duration and overall diagnostic yield. RESULTS: A total of 101 patients were randomized and completed the study. Complete examination of MDP was achieved in 98 patients using CA-EGD compared to 24 patients using S-EGD (97 vs. 24%, P<0.001). Median duration from intubation of the esophagus until localization of the MDP was shorter with CA-EGD (46. vs. 96 s., P<0.001). In group A, 11 extra lesions and 12 additional incidental findings were detected by secondary CA-EGD, whereas neither were detected by secondary S-EGD in group B (22 vs. 0% and 24 vs. 0%, P<0.001 and P<0.001). CONCLUSION: CA-EGD enabled complete examination of MDP in almost all cases compared to a low success rate of S-EGD. CA-EGD detected a significant amount of lesions and incidental findings when added to S-EGD. CA-EGD is a safe and effective method for examination of MDP.

Comparison of endoscopic sphincterotomy techniques after Billroth II gastrectomy using a novel mechanical simulator.

BACKGROUND AND AIMS: A postsurgical anatomy renders endoscopic sphincterotomy (EST) more challenging. Although different EST techniques for such a situation exist, comparative studies are lacking. The aim of the study was to compare the efficacy of different EST techniques using a novel mechanical simulator. METHODS: Ten expert endoscopists performed 6 different EST techniques on a novel mechanical Billroth II (BII) simulator in a random sequence. The EST techniques were (1) standard sphincterotome used with a side-viewing endoscope, (2) BII sphincterotome used with a side-viewing endoscope, (3) needle-knife EST guided by biliary endoprosthesis used with a side-viewing endoscope, (4) standard sphincterotome used with a forward-viewing endoscope, (5) BII sphincterotome used with a forward-viewing endoscope, and (6) needle-knife EST guided by biliary endoprosthesis used with a forward-viewing endoscope. The results of videotaped ESTs were evaluated by a blinded expert and duration for each EST modality was calculated. RESULTS: Needle-knife EST guided by endoprosthesis was rated superior to EST using a BII sphincterotome (p = 0.017) or a standard sphincterotome (p < 0.001). EST using the BII sphincterotome was significantly faster than EST with the needle knife (p = 0.004) and the standard sphincterotome (p = 0.005). There were no differences between the use of a forward-viewing endoscope and a side-viewing endoscope. CONCLUSION: In an ex vivo model for EST in B II gastrectomy needle-knife EST guided by endoprosthesis achieved superior ratings in comparison to the use of a BII sphincterotome, although it was more time-consuming. A standard sphincterotome should not be used for such a procedure.

Improving patient information - are the new media already requested? - A questionnaire study at a gastroenterology outpatient clinic.

Background Information provided for patients is an essential factor for communication between patients and health-care professionals. To analyze the most used sources of medical information and requested media for patient information, a questionnaire study was initiated. Methods A single-center questionnaire study at an outpatient clinic at a tertiary care hospital. Two hundred participating patients, average age 54.4 years (1:1.5 m:f). Results were displayed in total and as count per participant (i. e., how often is a medium mentioned per participant). Results As a source for general information, printed media are mentioned 112 times (0.56 counts per participant), the Internet 125 (0.62), and television 124 (0.62). As a source for medical information, printed media were mentioned 84 times (0.42) and the Internet 133 (0.67). As the most requested source for additional patient information, printed media were mentioned 105 times (0.53) and medical apps 63 (0.32). Conclusion A majority of our patients regularly use the Internet for medical information. Paper-print media are still highly requested by patients. New media are more often requested in younger patients but still reach the ages for screening programs and therefore offer big opportunities towards patient-doctor communication. By a good mixture of media provided a higher patient satisfaction and adherence could be ensured by the health-care professionals.

[The revised version of standard terminology in gastroenterological endoscopy - result of a consensus project of the german society for gastroenterology, digestive and metabolic diseases]. / Neufassung der Standard-Terminologie in der gastroenterologischen Endoskopie ­ Ergebnis eines Konsensusprojekts der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten.

A uniform and comprehensive terminology is essential in the correct documentation of diagnostic or therapeutic endoscopic procedure. In the German-speaking world, the standard terminology available so far is based on a previous version published in 1999. Therefore, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has undergone a comprehensive revision and re-structuring of the terminology. This appeared mandatory due to various changes, new diagnoses and new endoscopic procedures. The suggestions drawn up by individual working groups were approved by consensus and are now available as an online document (https://doi.org/10.1055/s-0043-121167) for modifying current software systems. In order to ensure an up-to-date documentation in the future, it was decided that annual updates will be performed by the DGVS to check respective software packages for modifications and new contents.

Narrow-band imaging vs. high definition white light for optical diagnosis of small colorectal polyps: a randomized multicenter trial.

BACKGROUND AND STUDY AIM: The aim of the study was to compare the latest narrow-band imaging (NBI) device with high-definition white light (HDWL) endoscopy for accuracy of real-time optical diagnosis of small colorectal polyps. PATIENTS AND METHODS: We conducted a randomized, prospective, multicenter trial at three study sites in Germany. In the NBI arm, endoscopists used NBI for the prediction of polyp pathology on the basis of the NBI International Colorectal Endoscopic classification. In the HDWL arm, NBI was not used for optical classification of polyp histology. The primary outcome was accuracy of optical diagnoses (neoplastic vs. non-neoplastic) in small polyps measuring < 10 mm. Secondary end points included sensitivity and negative predictive value (NPV). RESULTS: A total of 380 patients were randomized 1:1 to either the NBI or HDWL arm. A total of 421 polyps measuring < 10 mm were detected (55.8 % neoplastic, 44.2 % non-neoplastic). Accuracy, sensitivity, and NPV were 73.7 %, 82.4 %, and 75.5 %, respectively, in the NBI arm and 79.2 %, 79.8 %, and 73.4 %, respectively, in the HDWL arm (P = 0.225, P = 0.667, P = 0.765). More polyps were assessed with high confidence in the HDWL arm (82.6 %) than in the NBI arm (73.7 %; P = 0.038). The NPV of the prediction of neoplastic histology in diminutive polyps (≤ 5 mm) rated with high confidence was 90.3 % in the NBI arm. We detected significant differences between the participating study sites in the performance data of predictions. CONCLUSION: The levels of accuracy for real-time prediction of polyp histology (< 10 mm) did not differ between NBI and HDWL for optical diagnosis. Variation in the performance of optical diagnosis was apparent between study centers. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02009774).

Magnetic endoscope imaging for routine colonoscopy: impact on propofol dosage and patient safety - a randomized trial.

BACKGROUND AND STUDY AIM: The use of magnetic endoscope imaging (MEI) has been previously shown to facilitate colonoscopy procedures. We aimed to evaluate the benefits of MEI in terms of reduction in propofol dosage in patients undergoing routine colonoscopy. METHODS: We conducted a randomized prospective trial in a university hospital in Germany. Endoscopists were randomly assigned 1:1 to use MEI during colonoscopy (MEI arm) or to conduct colonoscopy without the use of MEI (standard arm). The desired level of sedation was conscious sedation as assessed using the Observer's Assessment of Alertness and Sedation scores. After complete recovery, patient satisfaction was assessed using a numeric rating scale (NRS) ranging from 1 to 10 points. The primary outcome was total propofol dosage. Secondary outcome measures were patient satisfaction, patients' cooperation, and complication rates, as well as cecal intubation time and adenoma detection. RESULTS: Among 334 randomized patients, no severe adverse events were observed. Median propofol dosage was significantly lower in the MEI arm compared with the standard arm (150 mg vs. 180 mg; P = 0.04). Deep sedation was observed in 7.8 % of patients in the MEI group and 3.6 % in the standard arm (P = 0.10). Patient satisfaction scores were higher in the MEI arm compared with standard procedures (9.0 vs. 8.5; P = 0.04). No significant differences in patients' cooperation, cecal intubation time, and adenoma detection were observed between the study arms. CONCLUSION: The use of MEI may be useful in reducing propofol dosage for colonoscopy and improving patient satisfaction.ClinicalTrials.gov identifier: NCT02121704.

Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study).

BACKGROUND AND STUDY AIMS: This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP). METHODS: Patients (American Society of Anesthesiologists [ASA] I ­â€ŠIV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction). RESULTS: 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups. CONCLUSION: Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.