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.

Long-term follow-up after dilation in symptomatic esophageal intramural pseudodiverticulosis: an observational study in 22 cases.

Endoscopic bougienage seems to be the most effective therapy for dysphagia in esophageal intramural pseudodiverticulosis (EIPD), but nothing is known about the long-term success of this treatment option. This report presents long-term results for 21 of 22 patients with EIPD who were treated with bougienage. A total of 103 sessions of bougienage up to a diameter of 18 mm were performed, without major complications and with 100 % clinical success. During follow-up, symptom recurrence with further bougienage occurred in 12 /21 patients (57 %), who had variable symptom-free intervals (range 1.5 - 96 months). Symptom recurrence was associated with concomitant reflux esophagitis. Although this series demonstrates that bougienage is an effective method for relieving dysphagia in EIPD, the long-term effectiveness is limited.

Idiopathic Frozen Shoulder in Individuals with Diabetes: Association with Metabolic Control, Obesity, Antidiabetic Treatment and Demographic Characteristics in Adults with Type 1 or 2 Diabetes from the DPV Registry.

AIMS: To examine the association of frozen shoulder (FS) with demographic and diabetes-related outcomes in individuals with type 1 (T1D) or type 2 (T2D) diabetes aged ≥30 years. MATERIALS AND METHODS: Multivariable logistic regression models, adjusted for demographics were used to calculate the proportion of FS in association with age, gender, diabetes duration, body mass index (BMI), haemoglobin A1C (HbA1c) and diabetes treatment. RESULTS: The unadjusted percentage of FS was higher in T1D compared to T2D (0.22% vs. 0.06%). In T1D, adjusted regression models revealed higher prevalence of FS in women than men (0.26 [0.20-0.34] % vs. 0.15 [0.11-0.21] %, p=0.010). No significant relationship of age and BMI with FS was found in both diabetes types. Longer diabetes duration was associated with a higher proportion of FS in T1D (p<0.001) and T2D (p=0.004). In T1D, HbA1c >7% was related to a higher proportion of FS compared to HbA1c ≤7% (0.25 [0.19-0.32] vs. 0.12 [0.08-0.20] %, p=0.007), while an inverse relationship was found in T2D (HbA1c ≤7%: 0.08 [0.07-0.10] vs. HbA1c >7%: 0.05 [0.04-0.06] %, p=0.001). CONCLUSIONS: Different associations of FS with gender and HbA1c were observed for T1D and T2D; however, longer diabetes duration increases the risk for FS independent of diabetes type. Musculoskeletal diseases are still underreported in individuals with diabetes and awareness should be raised for FS as a specific diabetes complication.

Determining scope position during colonoscopy without use of ionizing radiation or magnetic imaging: the enhanced mapping ability of the NeoGuide Endoscopy System.

BACKGROUND: Knowledge of the position and shape of the endoscope could overcome many challenges of performing colonoscopy, e.g., loop formation. A novel computer-assisted colonoscope (NeoGuide Endoscopy System) delivers a real-time, three-dimensional map of the tip position and insertion tube shape in addition to the video image of the colon lumen. The aim of this study is to evaluate the mapping capabilities of the NeoGuide Endoscopy System in terms of colonic looping, insertion depth, tip position, and tip angle formation. METHODS: Ten endoscopists with various levels of experience were each shown 70 map images generated by the NeoGuide endoscopy system in a benchtop anatomical colon model. First endoscopists were asked to determine the tip angle based on the map image and the system's corresponding tip positioning aid (20 images). In the second part they had to identify the scope-tip position in the colon model (40 images). In the third part ten images were presented for identification of colonic loops. RESULTS: The tip angle was correctly identified in 99% (198/200) of images. Using only the map images the scope position was accurately determined in 87.5% (350/400). Identification of colonic looping of the scope was appropriate in 99% (99/100). Overall accuracy was 92.4%, and overall positive predictive value was 94.9%. CONCLUSION: Three-dimensional map images generated by the NeoGuide endoscopy system provide accurate information regarding tip position, insertion tube position, and colonic looping.

[Abdominal Sonography in Medical Emergencies: do Complete Abdominal Scans offer Advantages over a Focused Strategy?] / Internistische Sonografie des Abdomens für Notaufnahmepatienten: Bietet eine vollständige Abdominalsonografie Vorteile?

PURPOSE: To determine, whether in case of abdominal emergencies, complete abdominal ultrasound scans offer advantages over a goal-directed strategy in regard to problem-solving and detection of relevant pathologies. MATERIAL AND METHODS: Retrospective analysis of consecutive emergency exams that were ordered by the ER in our gastroenterological sonography unit from 06/2012 to 06/2013. All patients got an ultrasound of the complete abdomen.We compared the findings of the complete abdomen study with the findings of a hypothetical focused sonography. The scope of the focused sonography depended on the presenting problem. An ultrasound finding was classified as relevant, if it triggered diagnostic or therapeutic consequences.Sensitivity and negative predictive value of the goal-directed strategy were calculated with the full abdominal scan as reference. RESULTS: 629 patients (53 % female), with an average age of 59 years (18-97) had emergency sonographies.Focused sonography detected relevant pathologies in 63 % (396/629) of patients. In 17 % of patients (106/629) complete abdominal ultrasound led to additional relevant findings. This translates into a number needed to scan for relevant pathologies of 6. Focused sonography had a sensitivity of 76 % and a negative predictive value of 64 % for relevant pathologies.The problem could be solved by 57 % of focused sonographies, whereas complete abdominal scans solved the problem in 63 % for a number needed to scan of 18. Sensitivity and negative predictive value of focused sonography were 87 % and 63 % respectively.The rate of problem-solving-scans depended on the indication (with jaundice having the highest (90 %) and left-upper-quadrant pain having the lowest (45 %) rate) and increased with age (37 % for the second decade up to 85 % for the 10th decade). CONCLUSION: In medical abdominal emergencies, ultrasound scans of the complete abdomen detect more relevant pathologies and solve more problems than focused sonography does.

Follow-up of patients with obscure gastrointestinal bleeding after capsule endoscopy and intraoperative enteroscopy.

BACKGROUND/AIMS: Capsule endoscopy (CE) is highly sensitive to detect the bleeding source in patients with obscure gastrointestinal bleeding compared with intraoperative enteroscopy (IOE). Long-term follow-up information of patients undergoing CE and IOE for investigation and treatment of chronic gastrointestinal bleeding is lacking. METHODOLOGY: 50 patients with obscure gastrointestinal bleeding underwent CE and IOE. Follow-up data of 47 patients (30 men, 17 women, mean age 60.9 +/- 16.8 years) were available (3 patients lost in follow-up). Clinical outcome was assessed with a standardized patient questionnaire and personal communication with referring physicians. RESULTS: Bleeding sources were detected and effective treated during intraoperative enteroscopy (argon plasma coagulation or surgical resection) in 34 patients [(angiodysplasias (n = 22), ulcers (n = 5), malignant tumors (n = 3), Meckel's diverticulum (n = 1), jejunal varices (n = 1), bleeding ileum diverticulosis (n = 1), hyperplastic polyp (n = 1)]. Mean follow-up was 346.3 days (range 253-814 days). Clinical signs of recurrent gastrointestinal bleeding occurred in 12 of 47 patients (25.5%) [positive fecal occult blood test (n = 2), anemia (n = 2), melena (n = 3), hematochezia (= 5)]. In 3 patients (6.4%) no further therapy was necessary, 9 patients (19.1%) needed blood transfusions (range 2-62 units), endoscopic or surgical interventions to control rebleeding. CONCLUSIONS: The results of the present study support the proposal that capsule endoscopy could be used as the first-choice investigation in patients with obscure gastrointestinal bleeding.

Risk factors for symptomatic stone recurrence after transpapillary laser lithotripsy for difficult bile duct stones using a laser with a stone recognition system.

BACKGROUND: Laser-induced shock-wave lithotripsy (LISL) is successfully used for the treatment of difficult bile duct stones. The aim of this study was to assess the long-term risk for a symptomatic bile duct stone recurrence after LISL and to detect risk factors predicting recurrence. METHODS: Between 1993 and 2001, 80 patients with difficult bile duct stones were successfully treated by intracorporeal LISL through the papilla of Vater. Seventy-one of these patients [median age, 65.8 years; 51 women (71.8%)] were followed for a median (range) period of 58 (1-114) months. RESULTS: Eleven patients (15.5%) had a symptomatic stone recurrence. The median (range) period between laser lithotripsy and recurrence was 40 (5-85) months. The presence of a bile duct stenosis (P=0.032) and a body-mass index below 25 (P=0.025) were significantly associated with an increased risk for stone recurrence. A gallbladder in situ, the presence of gallbladder stones, dilation of the bile duct, or a peripapillary diverticulum was not associated with stone recurrence. CONCLUSIONS: The presence of a bile duct stenosis is significantly related to bile duct stone recurrence after treatment with LISL. The impact of the body mass index on stone recurrence is interesting. The gallbladder status did not predict stone recurrence in our study.

Diagnosis of obscure gastrointestinal bleeding by intra-operative enteroscopy in 81 consecutive patients.

AIM: To analyze the results and complications of intra-operative enteroscopy (IOE) by investigating a series of selected patients with bleeding suspected to originate from the small intestine. METHODS: Eighty-one patients (mean age: 65 years) including 40 males (49.4%) and 41 females (50.6%) with obscure gastrointestinal bleeding underwent IOE between 1990 and 2004. The patients were identified from a database and data were selected from the patients' charts retrospectively. All the patients had undergone at least one non-diagnostic esophagogastroduodenoscopy, colonoscopy, standard enteroscopy and a negative abdominal ultrasound scan before IOE. RESULTS: The median minimal hemoglobin level in the patients was 59 + 15 g/L and 72.8% of the patients required transfusion of packed erythrocytes previously. A bleeding source was detected in 68 (84%) of the patients during IOE. Angiodysplasiae were found in 44 patients (54.3%) and 9 patients (11.1%) were affected by ulcers in the small intestine. A tumor in the small intestine was detected in another 6 patients. The treatment consisted of argon-plasma-coagulation, surgical suture or limited resection in most of the patients. CONCLUSION: Intra-operative enteroscopy is still used for the diagnosis of suspected small bowel bleeding. Recent developments such as wireless capsule endoscopy and double balloon enteroscopy, may lead to the replacement of IOE in the future.

The role of imaging and navigation for natural orifice translumenal endoscopic surgery.

BACKGROUND AND PURPOSE: One of the next frontiers of minimally invasive surgery is natural orifice translumenal endoscopic surgery (NOTES). This article focuses on the perspectives and limitations of imaging and navigation in NOTES soft-tissue surgery. MATERIALS AND METHODS: Based on our in-vitro and in-vivo studies, with the applicability of different systems for image-guided soft-tissue endoscopic surgery, early experience with NOTES, and long-term experience with advanced endoluminal, laparoscopic robot-assisted endoscopic surgery, we performed a review of the literature. The aim was a critical analysis of the current role of imaging during NOTES. RESULTS: There are several steps/problems with NOTES that might be significantly alleviated by use of imaging and soft-tissue navigation. One has to distinguish between preoperative planning and intraoperative imaging or navigation. NOTES represents a hybrid technique of laparoscopy and endoscopy with similar limitations in perception and two-dimensional imaging; however, the use of flexible instruments increases the complexity with respect to the spatial orientation. This applies not only for the surgeon, but also for tracking devices for surgical navigation systems. Unlike optical navigation systems, electromagnetic and endoscopic (inside-out) tracking devices might be best suited to NOTES. CONCLUSION: The safe realization and standardization of NOTES represents a real challenge that necessitates close and effective interdisciplinary collaboration of surgeon, technicians, informatics, and endoscopic and applied industries. Image-guided soft-tissue navigation may be very helpful to minimize the hazards of the technically challenging procedure.

Computer-assisted colonoscopy (the NeoGuide Endoscopy System): results of the first human clinical trial ("PACE study").

OBJECTIVES: Unsedated colonoscopy is an uncomfortable procedure for most patients. Discomfort during colonoscopy is largely related to looping of the colonoscope, which displaces the colon from its native configuration and stretches attachments to the mesentery. A novel computer-assisted colonoscope utilizes a fully articulated, computer-controlled insertion tube. On manual insertion of the colonoscope, the position and angle of the scope's tip are encoded into a computer algorithm. As the colonoscope is advanced, the computer directs each successive segment to take the same shape that the tip had at a given insertion depth. The insertion tube thus changes its shape at different insertion depths in a "follow-the-leader" manner. METHODS: This initial clinical trial with this novel colonoscopy system was designed as a prospective, nonrandomized, unblinded, feasibility study. Three physicians of varying levels of experience participated in the study. RESULTS: Eleven consecutive patients (seven men, four women, age range 19-80) meeting inclusion criteria for screening or diagnostic colonoscopy were enrolled in the study. The cecum was reached in 10 consecutive patients (100%). Findings included diverticular disease in two cases and multiple colonic polyps in two cases. Postprocedure assessment at discharge, 48 h, and 30 days revealed no complications or adverse effects. Physician satisfaction and patient acceptance of this new technique were high. CONCLUSIONS: In this limited, first of its kind feasibility study, the computer-assisted colonoscope was shown to perform colonoscopy safely and effectively. The colonoscope's unique design limited loop formation during colonoscopy. Large-scale clinical trials are indicated.

Bacteremia after diagnostic conventional laparoscopy and minilaparoscopy: a prospective study in 100 patients.

BACKGROUND/GOALS: Diagnostic laparoscopy under sedoanalgesia is a valuable tool in the work-up of liver diseases and is helpful as a staging procedure. The rate of bacteremia caused by this procedure is unknown, in particular when performed as minilaparoscopy. STUDY: A 100 consecutive patients having undergone diagnostic laparoscopy carried out either conventionally (group I, n=50) or as minilaparoscopy (group II, n=50) were prospectively enrolled in this study. Blood cultures were drawn before and within 5 minutes after the procedure. Risk factors for bacteremia were evaluated. RESULTS: Bacterial growth occurred in 4 blood cultures drawn immediately after laparoscopy. No patient developed fever or other signs of infection in the follow-up. Risk factors predisposing to bacteremia could not be identified. CONCLUSIONS: Conventional diagnostic laparoscopy under sedoanalgesia and minilaparoscopy are associated with a low rate of bacteremia as in diagnostic upper endoscopy.

Accuracy of high-resolution chromoendoscopy in prediction of histologic findings in diminutive lesions of the rectosigmoid.

BACKGROUND: The ability to differentiate adenomatous from nonadenomatous colonic polyps by using chromoendoscopy would obviate the need to remove hyperplastic lesions. The aim of this study was to define the accuracy of high-resolution chromoendoscopy for the determination of colonic polyp histology. METHODS: In 158 patients, 273 polyps (<5 mm) in the rectosigmoid were estimated for their histology. The endoscopists, in two steps, predicted the histopathology of each lesion on the basis of its surface characteristics by using high-resolution colonoscope without any staining and after indigo carmine dye according to the Kudo classification. RESULTS: The resected polyps included 48 adenomatous and 225 nonadenomatous polyps. When histologically confirmed hyperplastic polyps were compared with adenomatous polyps, the prediction of hyperplastic polyps based on endoscopic findings had a sensitivity of 93%, a specificity of 60%, and an overall accuracy of 81%. The corresponding sensitivity, specificity, and overall accuracy after indigo carmine dye were 94%, 64%, and 83%, respectively. CONCLUSIONS: The results suggest that the chromoendoscopy only marginally improves the determination between hyperplastic and adenomatous polyps when using high-resolution colonoscopes. The overall accuracy rate increased after dyeing, from 81% to 83%. The omission of histopathologic analysis cannot yet be achieved by chromoendoscopy.

Improved preoperative tumor staging by 5-aminolevulinic acid induced fluorescence laparoscopy.

BACKGROUND: We report our data in 35 patients who underwent preoperative conventional and fluorescence-based staging laparoscopy. We use the data to address the questions of whether fluorescence examination increases the yield of metastatic lesions and alters treatment intervention. METHODS: Fluorescence laparoscopy was successfully performed in 30 patients with GI malignancies. After sensitization with 5-aminolevulinic acid, conventional white-light mode and fluorescence-light laparoscopies were sequentially performed. A suspected malignancy was biopsied. OBSERVATIONS: In 5 patients, examinations were incomplete because of adhesions. In 9 of 10 patients, hepatic or peritoneal metastases were detected by white-light examination. In 4 of these 9, blue-light examination yielded more metastatic lesions. In one patient with no lesions by white- or blue-light examination, surgery revealed hepatic metastasis in a location not accessible to laparoscopic examination. In 18 patients, surgery confirmed the absence of metastatic lesions. CONCLUSIONS: A fluorescence, blue-light examination yielded more lesions than the conventional white-light examination but did not alter treatment intervention and did not enhance yield when metastatic lesion is in an inaccessible location. Continued research should focus on whether treatment intervention will be altered by the fluorescence examination.

Diagnosis of liver cirrhosis: a comparison of modified ultrasound and laparoscopy in 100 consecutive patients.

BACKGROUND/GOALS: Liver cirrhosis, the final stage of chronic liver disease, is characterized by an unfavorable prognosis and an increased risk of hepatocellular carcinoma and also requires an appropriate management. Laparoscopy, the gold standard in the diagnosis of cirrhosis, is hampered by its invasiveness. Therefore, a noninvasive method for diagnosing liver cirrhosis would be of great benefit. STUDY: A consecutive series of 100 patients, sent to our gastroenterological unit for diagnostic laparoscopy, underwent a standardized ultrasonographic examination prior to laparoscopy. RESULTS: Conventional ultrasonographic examination revealed a sensitivity of 55% and a specificity of 86% in the diagnosis of cirrhosis. Considering the assessment of the transmission of heart pulsation on the liver surface, the corresponding values improved by increasing to 85% and 93%. CONCLUSION: Evaluating the transmission of heart pulsation on the liver surface improves the ability of ultrasound to diagnose liver cirrhosis; therefore, it should be an integral part of routine sonographic examination of the liver.

Self-expanding metal stents versus plastic prostheses in the palliation of malignant dysphagia: long-term outcome of 153 consecutive patients.

BACKGROUND: Malignant dysphagia due to esophagogastric cancer is associated with poor overall prognosis. Placements of self-expandable metal stents or plastic tubes are established methods as palliative treatment options. As an alternative and/or complementary therapy, radiologic techniques (external beam radiation/brachytherapy) and locally endoscopic techniques (laser, APC-beamer, PDT) are often used. STUDY AND GOALS: Retrospective trial of 153 patients treated in our department between 1993 and 2001. Forty-five patients received a plastic tube (Group A) and 108 patients were treated with metal stents (Group B). Both groups were compared for improvement of dysphagia score, survival, recurrent dysphagia and complications. RESULTS: Stent placement was successful in 41 of 45 (93%) patients of Group A and 107 of 108 (99%) of Group B. The median dysphagia score improved significantly in Group A (from 3.03 to 1.55, P = 0.010) and Group B (from 2.77 to 1.44, P = 0.009). Recurrent dysphagia was noted in 12 of 45 (27%) patients of Group A and 27 of 108 (25%) patients of Group B. Median survival time after stent insertion was 78 days (Group A) and 113 days (Group B). Overall complications occurred in 15 of 45 (33%) patients of Group A and 28 of 108 (26%) patients of Group B. However, significantly (P = 0.05) more major complications were seen in Group A than in Group B (22% vs. 9%). CONCLUSIONS: Our results indicate a marginal clinical benefit for metal stents versus plastic tubes in malignant dysphagia in the long run. However, metal stents seem to be safer and associated with a prolonged improvement of dysphagia score.

A prospective two-center study comparing wireless capsule endoscopy with intraoperative enteroscopy in patients with obscure GI bleeding.

BACKGROUND: Capsule endoscopy enables noninvasive diagnostic examination of the entire small intestine. However, sensitivity and specificity of capsule endoscopy have not been adequately defined. We, therefore, compared capsule endoscopy by using intraoperative enteroscopy as a criterion standard in patients with obscure GI bleeding. METHODS: Forty-seven consecutive patients with obscure GI bleeding (11 with ongoing overt bleeding, 24 with previous overt bleeding, and 12 with obscure-occult bleeding) from two German gastroenterologic centers were included. All patients who had a prior nondiagnostic evaluation, including upper endoscopy, colonoscopy with a retrograde examination of the distal ileum, and push enteroscopy, underwent capsule endoscopy followed by intraoperative enteroscopy. RESULTS: Capsule endoscopy identified lesions in 100% of the patients with ongoing overt bleeding, 67% of the patients with previous overt bleeding, and 67% of the patients with obscure-occult bleeding. Angiectasias were the most common source of bleeding (n = 22). Capsule endoscopy showed the source of bleeding in 74.4% of all patients. The method was more effective in patients with ongoing bleeding. Compared with intraoperative enteroscopy sensitivity, specificity, and positive and negative predictive values of capsule endoscopy were 95%, 75%, 95%, and 86%, respectively. CONCLUSIONS: Capsule endoscopy has high sensitivity and specificity to detect a bleeding source in patients with obscure GI bleeding. Thus, wireless capsule endoscopy can be recommended as part of the routine work-up in patients with obscure GI bleeding.