EMR + with the AWC improves endoscopic resection speed compared to ESD: a porcine ex-vivo pilot study.

INTRODUCTION: To improve resection speed and to reach higher en bloc resection rates in lesions ≥ 2 cm, a novel grasp and snare EMR technique termed "EMR+", accomplished by an additional working channel (AWC), was developed. Its use compared to endoscopic submucosal dissection (ESD) is evaluated for the first time. MATERIAL AND METHODS: We prospectively conducted a randomized pre-clinical ex-vivo pilot study in explanted porcine stomachs for the comparison of EMR + with classical ESD of mucosal-based lesions. Prior to intervention, we set flat lesions with a standardized size of 3 × 3 cm. RESULTS: The median time of procedure was significantly shorter in the EMR + group (median 10.5 min, range 4.4-24 min) than in the ESD group (median 32 min, range 14-61.6 min, p < .0001). The rate of en bloc resection was significantly lower in the EMR + group (38 % vs. 95 %) (p < .0001). Nevertheless, an improvement in the learning curve for EMR + was achieved after the first 12 procedures, with a subsequent en bloc resection rate of 100 %. CONCLUSIONS: EMR + could improve the efficiency of mucosal resection procedures. Initial experience demonstrates a higher and satisfactory en bloc resection rate after going through the learning curve of EMR+.

Long term follow up of through-the-scope balloon dilation as compared to strictureplasty and bowel resection of intestinal strictures in crohn's disease.

BACKGROUND & AIMS: Ileo-colonic strictures are common complication of Crohn's disease (CD), and may result in repeated endoscopic or surgical therapy with a risk of further complications, such as perforation or short bowel syndrome. Strictures develop as a consequence of tissue remodelling and fibrosis due to chronic inflammation. This study compares the outcome of CD patients undergoing primarily endoscopic treatment with those undergoing surgery at an university hospital. METHODS: In this study we retrospectively included 88 CD patients with intestinal strictures (37 males, 51 females, mean age 40 years, range 19-65 years) of both our medical and our surgical department, who underwent either surgical or endoscopic therapy between January 2002 and January 2006 with prospective, controlled follow-up, extended till January 2010 (mean follow-up period: 5 years; range 4-8 years). The primary end-point was operation- and symptom-free time. Patients were primarily divided into four groups: only surgical therapy, only endoscopic therapy, endoscopy with subsequent surgery, and initial surgical therapy followed by endoscopic dilations. RESULTS: 53% of all patients remained surgery-free with mean follow-up of 49 months; a single endoscopic dilation was sufficient enough in 9 patients to achieve a surgery-free time of 51 months, other patients required up to 5 dilations. The average interval between first and second dilation was 6.5 months, between second and third 10.5 months. In the group of patients with only endoscopic therapy, surgery- and symptom-free time was shorter, as compared to the group of only surgical therapy. We found that stenoses in the surgical group with an average length of 6.5 cm were as expected longer, as compared to the endoscopic group (3 cm, ranging from 2-4 cm). The surgery-free time was 49 months (42-71 months, P = 0.723) with a symptom-free time of 12 months (4.5-46 months, P = 0.921). In the group of only surgically treated patients, 68.4% of the patients had only one stenosis, 18.4% had 2-3 stenoses and 13.2% more than 3 stenoses. In all patients the surgery- and symptoms- free time was 69 months (57-83 months, P = 0.850 and 0.908). The other two groups showed similar results. We found no significant effect of characteristic of stenosis (length, inflammation, the number of stenoses), injection of prednisolone, disease activity at the time of dilation and medication at the time of dilation on the long-term outcome. Importantly, the success of symptom free time correlated with the diameter of the balloon. CONCLUSIONS: Endoscopic dilation should be considered as a first-line therapy for short, accessible, fibrotic strictures. Careful patient selection and proper diagnostic imaging pre-procedure are essential requirements for safe and successful treatment. The balloon diameter seems to correlate positively with the long term outcome of dilation. However, at ever shorter intervals between endoscopic interventions, surgery should be discussed as an option for further treatment.

Hemodynamic efficacy of the over-the-scope clip in an established porcine cadaveric model for spurting bleeding.

BACKGROUND: Clip application has been proven to be effective for endoscopic hemostasis. There are limited bench data on the efficacy of the over-the-scope clip (OTSC) for the treatment of spurting GI hemorrhage. We evaluated the hemodynamic efficacy of the OTSC in an established bleeding model. OBJECTIVE: To evaluate the hemodynamic efficacy of the OTSC in an established bleeding model. DESIGN: Prospective experimental trial with historical comparison. SETTING: We tested the OTSC prospectively in a validated bleeding model by using the compact Erlangen Active Simulator for Interventional Endoscopy equipped with an upper GI organ package. The artificial blood circulation system of the simulator was connected to an arterial pressure transducer. Two investigators with different endoscopic experience (4000 and 10,000 endoscopies performed) participated. Each investigator treated 16 bleeding sites in the simulator with the OTSC by using only suction (n = 8) and a novel retraction device to grasp tissue (n = 8). Systemic pressures were recorded 1 minute before, during, and 1 minute after clip application to objectify the effects of clipping on the vessel diameter. MAIN OUTCOME MEASUREMENTS: Mean and maximum reduction in vessel diameter. RESULTS: The application of the OTSC on the bleeding vessel led to a significant increase in systemic pressure (P < .001) and decreased vessel diameter (P < .001) independent of the endoscopic experience of the investigator. There was no difference in the decrease in vessel diameter based on the application technique (suction vs suction plus grasping). A historical comparison with our former trials demonstrated that the OTSC decreased the vessel diameter significantly more than other traditional endoclips. LIMITATIONS: Small sample size. CONCLUSIONS: We could demonstrate the efficacy of the OTSC with increased hemodynamic efficiency compared with other endoscopic clip devices tested previously.

Strategies for training in diagnostic upper endoscopy: a prospective, randomized trial.

BACKGROUND: Training simulators have been used for decades with success; however, a standardized educational strategy for diagnostic EGD is still lacking. OBJECTIVE: Development of a training strategy for diagnostic upper endoscopy. STUDY DESIGN: Prospective, randomized trial. SETTINGS: A total of 28 medical and surgical residents without endoscopic experience were enrolled. Basic skills evaluations were performed following a structured program involving theoretical lectures and a hands-on course in diagnostic EGD. Subsequently, stratified randomization to clinical plus simulator training (group 1, n = 10), clinical training only (group 2, n = 9), or simulator training only (group 3, n = 9) was performed. Ten sessions of simulator training were conducted for groups 1 and 3 during the 4-month program. Group 2 underwent standard training in endoscopy without supplemental simulator training. The final evaluation was performed on the simulator and by observation of 3 clinical cases. Skills and procedural times were recorded by blinded and unblinded evaluators. MAIN OUTCOME MEASUREMENTS: Time to reach the duodenum, pylorus, or esophagus. RESULTS: All trainees demonstrated a significant reduction in procedure time during a simple manual skills test (P < .05) and significantly better skills scores (P = .006, P = .042 and P = .017) in the simulator independent of the training strategy. Group 1 showed shorter times to intubate the esophagus (61 ± 26 seconds vs 85 ± 30 seconds and 95 ± 36 seconds) and the pylorus (183 ± 65 seconds vs 207 ± 61 seconds and 247 ± 66 seconds) during the clinical evaluation. Blinded assessment of EGD skills showed significantly better results for group 1 compared with group 3. Blinded and unblinded evaluations were not statistically different. LIMITATIONS: Small sample size. CONCLUSIONS: Structured simulator training supplementing clinical training in upper endoscopy appears to be superior to clinical training alone. Simulator training alone does not seem to be sufficient to improve endoscopic skills.

Double-balloon-enteroscopy-based endoscopic retrograde cholangiopancreatography in post-surgical patients.

AIM: To evaluate double balloon enteroscopy (DBE) in post-surgical patients to perform endoscopic retrograde cholangiopancreatography (ERCP) and interventions. METHODS: In 37 post-surgical patients, a stepwise approach was performed to reach normal papilla or enteral anastomoses of the biliary tract/pancreas. When conventional endoscopy failed, DBE-based ERCP was performed and standard parameters for DBE, ERCP and interventions were recorded. RESULTS: Push-enteroscopy (overall, 16 procedures) reached enteral anastomoses only in six out of 37 post-surgical patients (16.2%). DBE achieved a high rate of luminal access to the biliary tract in 23 of the remaining 31 patients (74.1%) and to the pancreatic duct (three patients). Among all DBE-based ERCPs (86 procedures), 21/23 patients (91.3%) were successfully treated. Interventions included ostium incision or papillotomy in 6/23 (26%) and 7/23 patients (30.4%), respectively. Biliary endoprosthesis insertion and regular exchange was achieved in 17/23 (73.9%) and 7/23 patients (30.4%), respectively. Furthermore, bile duct stone extraction as well as ostium and papillary dilation were performed in 5/23 (21.7%) and 3/23 patients (13.0%), respectively. Complications during DBE-based procedures were bleeding (1.1%), perforation (2.3%) and pancreatitis (2.3%), and minor complications occurred in up to 19.1%. CONCLUSION: The appropriate use of DBE yields a high rate of luminal access to papilla or enteral anastomoses in more than two-thirds of post-surgical patients, allowing important successful endoscopic therapeutic interventions.

Refinement of ERCP by using the Olympus V-scope system with a 0.025 in. compatible and complete fixable Visiglide(®) guidewire.

AIM: Prospective evaluation of the new 0.025 in. Visiglide(®) guidewire to facilitate endoscopic retrograde cholangiopancreaticography using the Olympus V-scope. MATERIALS AND METHODS: Interventional endoscopic retrograde cholangiopancreaticography was performed in 9 patients with the Olympus V-scope and the 0.025 in. Visiglide(®) guidewire (VS group), whilst 9 other patients underwent endoscopic retrograde cholangiopancreaticography with a conventional Olympus duodenoscope using 0.035 in. conventional guidewires (controls). Exchange time of accessories, X-ray time, dose and endoscopic retrograde cholangiopancreaticography examination time were investigated. RESULTS: The VS group showed a significantly lower exchange time of endoscopic retrograde cholangiopancreaticography accessories (9; 4-10s, p<0.0001) than controls (29; 19-44s). The Visiglide(®) guidewire was complete fixable by the elevator in 35/36 instrument exchanges (97%) compared to 16/31 exchanges (52%) using conventional guidewires. LIMITATIONS: Single-centre study, small patient numbers, two investigators. CONCLUSIONS: Endoscopic retrograde cholangiopancreaticography using the Olympus V-scope with the new 0.025 in. Visiglide(®) guidewire enables a 3-fold faster exchange of accessories due to a nearly complete fixation of the guidewire.

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.

Entrance barriers and integration obstacles of NOTES.

Natural orifice transluminal endoscopic surgery (NOTES) changes the paradigm of endoscopy and even surgery. The artificial perforation of abdominal hollow organs is now welcome and no longer avoided under all circumstances. Surgeons as well as gastroenterologists face a lot of problems, barriers and integration obstacles. The interdisciplinary approach for the introduction of a new technique appears promising and opens a lot of perspectives. This paper illustrates and discusses medical, technical, financial and professional barriers and integration obstacles for the introduction of NOTES into clinical practice.

The complementary Erlangen active simulator for interventional endoscopy training is superior to solely clinical education in endoscopic hemostasis--the French training project: a prospective trial.

BACKGROUND: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) using ex-vivo porcine organs was introduced in 1997. The present study should analyze whether repeated EASIE simulator training in endoscopic hemostasis led to superior performance compared with a traditionally educated group. The results were compared with a similar project in New York. METHODS: Thirty-five French GI fellows were enrolled. Baseline skills evaluation was performed in four disciplines (manual skills, injection/coagulation, clip application and variceal ligation) using the compactEASIE-simulator equipped with an upper gastrointestinal organ package for bleeding simulation. The same, translated evaluation forms (from the prior New York project) were used. Subsequently, fellows were randomized into group A (n=17, only clinical education) and group B (n=18, additional three simulator trainings). Group B was trained the next day and after 4 and 7 months by experts of the French Society of Gastrointestinal Endoscopy. Both groups performed routine and emergency endoscopies at their home hospitals during the study period. Both groups were re-evaluated blindly after 9 months. RESULTS: The learning curve for group B showed a significant improvement in all disciplines (P<0.004) whereas group A improved significantly in only two of four disciplines at blinded final evaluation (manual skills P=0.02, injection/coagulation P=0.013). The direct comparison of groups B and A at blinded final evaluation showed significantly superior ratings for group B in all disciplines (P<0.006) and significantly shorter performance times in two disciplines (P=0.016 each). The comparison with the similar 'New York project' revealed that preexisting differences in skills were adjusted by the training. CONCLUSION: Complementary trainings (three workshops in 7 months) in endoscopic hemostasis using the compactEASIE improved skills compared with a solely clinical education. The results of the 'New York project' were confirmed and benefits were independent from the medical educational system.

Currently available simulators: ex vivo models.

The introduction of the ex vivo tissue endoscopy simulators represents a major advance in endoscopic training, particularly in therapeutic endoscopy. The simulators have been popular teaching tools from the start, and the data supporting their benefit are accruing, especially in hemostasis training. Simulators like the compact EASIE may prove most beneficial as training tools for interventional skills that require repetitive practice and a larger volume of procedures than may occur naturally during the course of standard endoscopy practice. More data are needed to confirm that hands-on simulator training improves outcomes in clinical endoscopic performance and to characterize better the influence of such simulator work on subsequent endoscopic practice. As ex vivo simulators become more available, it is likely that these models will enhance initial training and also allow practicing gastroenterologists to acquire new techniques, maintain their skills, and demonstrate proficiency for credentialing purposes.

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.

Training with the compactEASIE biologic endoscopy simulator significantly improves hemostatic technical skill of gastroenterology fellows: a randomized controlled comparison with clinical endoscopy training alone.

BACKGROUND: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 for interventional endoscopy training. compactEASIE developed in 1998 is a modified, light-weight version of the original model. Objective evidence of the benefits of training with these models is limited. A randomized controlled study, therefore, was conducted to compare the effects of intensive 7-month, hands-on training in hemostatic techniques by using the compactEASIE model (in addition to clinical endoscopic training) vs. pure clinical training in endoscopic hemostatic methods. METHODS: Thirty-seven fellows in gastroenterology in New York City area training programs were enrolled. Baseline skills were assessed on the simulator for the following techniques: manual skills, injection and electrocoagulation, hemoclip application, and variceal ligation. Twenty-eight fellows were then randomized into two comparable groups. Those randomized to Group A received purely clinical training in endoscopic hemostatic techniques at their hospitals. Those in Group B, in addition, were trained by experienced tutors in 3 full-day hemostasis workshops over 7 months. Both groups underwent a final evaluation on the compactEASIE simulator conducted by their tutors and additional evaluators who were blinded to the method of training. Initial and final evaluation scores were compared for each group and between groups. Outcomes of actual clinical hemostatic procedures performed during the study period also were analyzed. RESULTS: Ten of 14 fellows randomized to Group A (standard training) and 13 of 14 in Group B (intensive training) returned for the final evaluation. For Group B, scores for all techniques were significantly improved. In Group A, a significant improvement was noted for variceal ligation alone. CONCLUSIONS: compactEASIE simulator training (3 sessions over 7 months), together with clinical endoscopic training resulted in objective improvement in the performance by fellows of all 4 endoscopic hemostatic techniques, whereas significant improvement was noted for variceal ligation alone for fellows who had standard clinical training. In clinical practice, fellows who had intensive simulator/clinical training had a significantly higher success rate and a nonsignificant reduction in the frequency of occurrence of complications.