Organ Package Research Articles

Learning curve for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic lesions in a novel ex-vivo simulation model

Background: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is essential in the management of digestive cancers. However, teaching and learning this technique remain challenging due to the lack of cost-effective models. Material and methods: This was a prospective experimental study using a complete porcine upper gastrointestinal ex-vivo organ package, placed in an Erlangen Active Simulator for Interventional Endoscopy (EASIE-R), and prepared with one cyst and two solid masses (2 cm). Five fellows inexperienced in EUS-FNA were enrolled, performing 10 procedures on each lesion, alternatively. The total time, number of attempts for success, of needle view losses, and of scope handling were recorded, associated with an independent skills rating by procedure. We compared the first 15 procedures with the last 15 for each fellow. Results: The fellows successfully performed all procedures in 2 to 40 minutes, requiring 1 to 6 attempts. All (5/5) improved their total time taken (P < 0.001), number of times when the EUS view of the needle was lost (P < 0.05), scope handling (P < 0.005), and skills rating (P < 0.001), whereas 4/5 (80 %) improved their number of attempts. The overall evaluation showed a significant decrease (P < 0.001) in the total time taken (11.2 ± 7.8 vs 4.3 ± 2.2 minutes), number of attempts (2.6 ± 1.2 vs 1.2 ± 0.7), number of times when the EUS view of the needle was lost (2.3 ± 2 vs 0.5 ± 0.7), and need for scope handling (1.1 ± 1.7 vs 0.1 ± 0.2). We also observed an improvement in skills rating (5 ± 1.9 vs. 7.7 ± 1.1). Conclusion: This newly designed ex-vivo model seems to be an effective way to improve the initial learning of EUS-FNA, by performing 30 procedures.

Robotic Sorting of Ovine Offal: Discussion of a Soft Peristaltic Approach

At present, animal offal is either processed manually or left unprocessed if sufficient labor is not available. In lamb meat processing, robotic solutions have been developed for removing the pelt, the internal organs, and the bones. Traditional robotic sensing and manipulation is, however, not applicable to handling the soft, slippery, and unordered organ package. We hypothesize that the problem of automatically sorting animal offal can be solved by a soft actuation technique and industrial robotics in conjunction with machine vision. In this article, we structure the technical approach, discuss its viability based on the available literature, and point out where its challenges lie. To this end, we conceptualize a robotic sorting system in which a peristaltic table is used to order the organ package. The ordering process is controlled using visual feedback from the automatic recognition of the organs. When an organ is in optimal position, it is picked up and lifted by a soft vacuum gripper. The exposed tissue connections to the organ package are cut and the organ is removed from the table. Gripper and cutter are mounted on a bi-arm robot. The peristaltic table has a soft silicone surface with a matrix of independently inflatable cells. By controlling inflation, moving wave shapes are produced that drive the organ package on the surface. Organs are recognized from sets of neighboring local features in color-depth images. Constellations of organs will be recognized by partitioning the feature space of a spatially sensitive multiorgan descriptor. A graphical model relates peristaltic movement patterns to organ configurations.

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

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. To evaluate the hemodynamic efficacy of the OTSC in an established bleeding model. Prospective experimental trial with historical comparison. 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. Mean and maximum reduction in vessel diameter. 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. Small sample size. We could demonstrate the efficacy of the OTSC with increased hemodynamic efficiency compared with other endoscopic clip devices tested previously.

ELITE -The ex vivo training unit for NOTES: Development and Validation

Skill training is an essential part of surgical education. Every physician has to get familiar with the various operation techniques and needs to handle the different instruments. However, mechanical and computer-based VR-simulators offer only one specific procedure, either laparoscopic or endoscopic. We designed the universal training system ELITE (endoscopic-laparoscopic interdisciplinary training entity) which is a new full synthetic ex vivo surgical training model for laparoscopic surgery, combined endoluminal/endocavitary procedures (“hybrid surgery”) and NOTES. The aim of the current investigation was to integrate respiration and electro dissection into the model, and the evaluation of both innovations. The ELITE is a full-size replica of a human female torso including a gas-tight abdominal wall and offering various accesses to the abdomen. A complete organ package including liver, gallbladder, spleen, gastrointestinal tract, including the mesentery and omentum is available for this system. Cholecystectomy and appendectomy can be simulated realistically with this new training system. For more realistic conditions during operations breathing-induced organ motion could be integrated into this system. Two latex balloons were inserted into the system to imitate the function of the diaphragm. They are inflated and deflated according to the respiration cycle and move the artificial organs in a natural way. Physicians, including endoscopic/laparoscopic novices and experts, were asked to train different NOTES procedures on the model. Performance of their training and subjective appraisal of the model itself were evaluated. The opportunity of electrodissection of the gallbladder and appendix and simulation of breath excursion of the diaphragm could successfully be implemented into the training system. One recently published study showed that ELITE is a suitable tool to train different surgical procedures. All subjects (novices and endoscopic/laparoscopic experts) showed a significant learning curve during the assessment. Experts could be reliably differentiated from novices. The actual evaluation of the model showed that 97% of the subjects considered the ELITE as a useful simulator for NOTES. ELITE was validated to be a suitable tool to train different NOTES procedures. As a step by step training of NOTES is highly recommended, this training system offers the opportunity by degrees that animal experiments can be replaced, especially, for learning of basic techniques and thus costs can be significantly reduced.

Improved ex vivo training model for percutaneous renal surgery

Percutaneous endourological procedures require an advanced level of skills. To facilitate the training of the proper technique, some years ago we developed a porcine ex vivo model for training percutaneous endourological procedures. When dilating the percutaneous tract silicone and gelatine were frequently damaged thus inhibiting proper working with the endoscopes. To circumvent these problems we improved our ex vivo model in order to be as close to the clinical situation as possible. The kidney with the ureter was dissected off the retroperitoneal organ package of the freshly slaughtered pigs. The kidneys were put into bags cut into parts of the thoracic/abdominal wall of these pigs. The renal pelvis can be filled with saline to simulate hydronephrosis; stones can be implanted for PCNL. Our new model allows for even better training of all percutaneous endourological procedures (e.g. percutaneous nephrostomy, PCNL, endopyelotomy). Especially puncturing is extremely close to the situation in humans as the porcine thoracic/abdominal wall in principal has the same anatomy as the human one. The new model has been already used with great success in hands-on courses. Concerning "tissue feeling", the anatomic relations and the great variety of procedures that can be trained, it is superior to non-biological models. Nevertheless, it is easily available and inexpensive.

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

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. 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. 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. 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.

Hemodynamic efficacy of the new resolution clip device in comparison with high-volume injection therapy in spurting bleeding: a prospective experimental trial using the compactEASIE simulator

Peptic ulcers are the most frequent cause of gastrointestinal bleeding. The use of hemoclips has become established as an effective form of treatment in addition to injection therapy. However, hemoclips have not previously been compared with injection therapy in an experimental setting using objective parameters. In a prospective, randomized, and controlled trial, the disposable Resolution hemoclip device (Boston Scientific, n = 40) was compared with conventional injection therapy (n = 40) in an experimental setting, using the compactEASIE simulator equipped with an upper gastrointestinal organ package to simulate bleeding. Four investigators with different levels of endoscopic experience participated in the study. On a randomized basis, each investigator treated 20 bleeding sites either by applying one clip (n = 10) or by carrying out high-volume four-quadrant injection (4 x 10 ml saline) of a spurting vessel. The efficacy of the hemostasis was assessed by continuous measurement of pressure within the afferent vessel before and after clip application or injection therapy and calculating the relative reduction in the vessel's diameter with each treatment method. The system pressure was recorded 1 min before and 1 min after treatment. The ease of application of each method was rated by the endoscopist and by the assisting nurse using a visual analogue scale (0 - 100, with 100 being best). All of the 40 hemoclipping and injection treatments were carried out successfully. Both methods led to a significant increase in peak pressure (Resolution clip 71.8 +/- 66.8 mm Hg, P < 0.001; injection 71.9 +/- 53.8 mm Hg, P < 0.001), representing a significant relative reduction in the vessel diameter. There were no significant differences in peak pressure between the two treatments ( P = 0.995). The mean increase in pressure during the first minute after the intervention (clip 49.3 +/- 67.0 mm Hg vs. injection 19.9 +/- 41.6 mm Hg) was significantly greater with the hemoclipping procedure ( P = 0.021). More experienced investigators achieved a greater increase in system pressure, but the difference was not significant. The assessments of the ease of application by the assistants (84 +/- 13) and endoscopists (86 +/- 16) did not show any significant differences ( P = 0.402) for the clipping device. No significant differences between the two treatment methods were detected with regard to the immediate efficacy of hemostasis. However, long-term hemostasis was better with hemoclipping. The endoscopist's level of experience also appears to play a role, particularly when hemoclips are used.

EX VIVO TRAINING MODEL FOR PERCUTANEOUS RENAL SURGERY

Percutaneous endourological procedures require an advanced level of skills. To facilitate training in the proper technique, simulators are helpful. Non-biological models, useful for learning the basic steps, do not represent the clinical situation in an ideal way. Recently, we developed a porcine urinary tract model for ureteroscopy. Proceeding from this experience, we developed a further ex vivo model for training percutaneous endourological procedures. The kidney with the ureter is dissected off of the retroperitoneal organ package of freshly slaughtered pigs. It is embedded in silicon. The renal pelvis can be filled with saline to simulate hydronephrosis, stones can be implanted for percutaneous nephrolithotomy. This ex vivo model allows training of all percutaneous endourological procedures (e.g. percutaneous nephrostomy, percutaneous lithotomy, endopyelotomy). It is an ideal way to train these techniques, being superior to non-biological models in terms of “tissue feeling” for anatomic relations, and the great variety of procedures that can be trained. Nevertheless, it is readily available and inexpensive.

Objective Benefit of a 1-day Training Course in Endoscopic Hemostasis Using the “compactEASIE” Endoscopy Simulator

The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 as a training model for interventional endoscopy. Objective evidence of the benefits of training with this model has not previously been published. As part of two long-term projects, the benefits of a 1-day training course with the "compactEASIE" simulator were evaluated. Fourteen American and 18 French gastroenterology fellows were enrolled. These fellows were participants in the intensive groups performing training in endoscopic hemostasis, with a total number of 28 fellows in New York and 36 in France. Gastrointestinal endoscopy faculty members in New York and France evaluated and timed the fellows in four disciplines to establish baseline skills (manual skills; injection and coagulation; Hemoclip application; and variceal ligation) with the compactEASIE simulator. The trainees were reevaluated after an intensive 1-day course (with two or three fellows and one instructor per station), also including preparation and assistance for each procedure. The assessment (overall and parts) was done by expert tutors using an ordinal scale ranging from 1 to 10 (1 = poorest, 10 = best), recording also mistakes and performance time. The compactEASIE simulator, equipped with an upper gastrointestinal organ package and an artificial blood perfusion system, was used as the training tool. A highly significant improvement ( P < or = 0.001) was observed in the performance of all endoscopic techniques. A significant reduction in performance time was also observed with three of the four endoscopic techniques. Successful hemostasis was significantly improved in two out of three techniques. A 1-day training course on endoscopic hemostasis using the compactEASIE simulator is capable of improving the performance of hemostasis procedures. Long-term effects of repeated training sessions are currently subject of collaborative studies in New York and France.

Ex vivo training model for percutaneous renal surgery

Percutaneous endourological procedures require an advanced level of skills. To facilitate training in the proper technique, simulators are helpful. Non-biological models, useful for learning the basic steps, do not represent the clinical situation in an ideal way. Recently, we developed a porcine urinary tract model for ureteroscopy. Proceeding from this experience, we developed a further ex vivo model for training percutaneous endourological procedures. The kidney with the ureter is dissected off of the retroperitoneal organ package of freshly slaughtered pigs. It is embedded in silicon. The renal pelvis can be filled with saline to simulate hydronephrosis, stones can be implanted for percutaneous nephrolithotomy. This ex vivo model allows training of all percutaneous endourological procedures (e.g. percutaneous nephrostomy, percutaneous lithotomy, endopyelotomy). It is an ideal way to train these techniques, being superior to non-biological models in terms of "tissue feeling" for anatomic relations, and the great variety of procedures that can be trained. Nevertheless, it is readily available and inexpensive.

Porcine Urinary Tract as a Training Model for Ureteroscopy

Objectives: Endourological procedures as ureteroscopy require an advanced level of skills. To facilitate the training of the proper technique, simulators are helpful. Nonbiological models, useful to learn the basic steps, do not represent the clinical situation in an ideal way. We therefore looked for a biological but nevertheless easily available model. Methods: The complete urinary tract is dissected off the retroperitoneal organ package of freshly slaughtered pigs. Results: The porcine urinary tract model allows for training all aspects of diagnostic and therapeutic ureteroscopy including lithotripsy and stenting in a way which is almost identical to the clinical situation in humans. Conclusions: The porcine urinary tract model is an ideal ex vivo model. Concerning ‘tissue feeling’ and anatomic relations, it is superior to nonbiological simulators. Nevertheless, it is quite easily available and inexpensive. In training courses, we have used it with great success.

3367 A prospective evaluation of 10 easie team-training workshops on endoscopic hemostasis.

Introduction:The Erlangen Active Simulator for Interventional Endoscopy (EASIE®) is a new close to life training model permitting for the first time the creation of artierial spurting ulcer bleedings, varices and polyps in a specially prepared pig stomach. Overall about 25 different interventional techniques in the upper GI-tract and hepatobiliary system can be trained. Methods:10 systematically structured EASIE team-training courses (21.3.98-8.5.99) on endoscopic hemostasis were evaluated prospectively by the participants according to a questionnaire at the end of one day training. The courses were designed as a team-training for groups of 3 doctors and 3 nurses per simulator. 207 of 283 participants (73.1%) filled in the questionnaire (133 doctors, 65 nurses). As training models 4x EASIE®, 3x miniEASIE®, 3x compactEASIE® were used all equipped with the same, specially prepared pig esophago-gastro-duodenal organ package. For the training of ulcer hemostasis, vessels, polyps and submucosal varices were created. Perfusion was achieved by a roller-pump with the addition of an on demand bypass regulating the pressure of the blood surrogate. Workshop structure: 30 min. theoretical introduction on treatment of ulcer bleeding, 2 hours practical training of injection techniques (epinephrine, fibrin glue) and hemoclip application, 30 min. theoretical introduction of variceal therapy, 2 hours practical training of sclerotherapy (including cyanoacrylat) and banding techniques. Results: Most trainees rated themselves as advanced (39%) or experienced (35%) endoscopists. 19% were endoscopic novices, 7% no statement. Previous experience in endoscopic hemostasis was distributed as follows: No experience 19%, <1 year 9%, 1- 3 years 22%, 3-6 years 21%, >6 years 20%, 9% no statement. Nearly all trainees assessed the training as excellent or good (83% excellent (++), 14% good (+), 0% unsatisfactory(-), 3% no statement Φ). Single techniques were evaluated as follows: Injection therapy:73% (++), 18% (+), 0% (-), 9% Φ; Clip application:83% (++), 9% (+), 1% (-), 7% Φ; Sclerotherapy:60% (++), 18%(+), 1%(-), 21%Φ; Multiband ligation: 77%(++), 17% (+), 0% (-),. 6% Φ; Closeness to realitywas assessed as good, specifically: 72% (++), 22% (+), 0% (-), 6% Φ. Conclusion: EASIE team-training endoscopic hemostasis has a high acceptance by the trainees. A prospective comparison between conventional endoscopic education and practical education in interventional endoscopy using EASIE will be done soon. Introduction:The Erlangen Active Simulator for Interventional Endoscopy (EASIE®) is a new close to life training model permitting for the first time the creation of artierial spurting ulcer bleedings, varices and polyps in a specially prepared pig stomach. Overall about 25 different interventional techniques in the upper GI-tract and hepatobiliary system can be trained. Methods:10 systematically structured EASIE team-training courses (21.3.98-8.5.99) on endoscopic hemostasis were evaluated prospectively by the participants according to a questionnaire at the end of one day training. The courses were designed as a team-training for groups of 3 doctors and 3 nurses per simulator. 207 of 283 participants (73.1%) filled in the questionnaire (133 doctors, 65 nurses). As training models 4x EASIE®, 3x miniEASIE®, 3x compactEASIE® were used all equipped with the same, specially prepared pig esophago-gastro-duodenal organ package. For the training of ulcer hemostasis, vessels, polyps and submucosal varices were created. Perfusion was achieved by a roller-pump with the addition of an on demand bypass regulating the pressure of the blood surrogate. Workshop structure: 30 min. theoretical introduction on treatment of ulcer bleeding, 2 hours practical training of injection techniques (epinephrine, fibrin glue) and hemoclip application, 30 min. theoretical introduction of variceal therapy, 2 hours practical training of sclerotherapy (including cyanoacrylat) and banding techniques. Results: Most trainees rated themselves as advanced (39%) or experienced (35%) endoscopists. 19% were endoscopic novices, 7% no statement. Previous experience in endoscopic hemostasis was distributed as follows: No experience 19%, <1 year 9%, 1- 3 years 22%, 3-6 years 21%, >6 years 20%, 9% no statement. Nearly all trainees assessed the training as excellent or good (83% excellent (++), 14% good (+), 0% unsatisfactory(-), 3% no statement Φ). Single techniques were evaluated as follows: Injection therapy:73% (++), 18% (+), 0% (-), 9% Φ; Clip application:83% (++), 9% (+), 1% (-), 7% Φ; Sclerotherapy:60% (++), 18%(+), 1%(-), 21%Φ; Multiband ligation: 77%(++), 17% (+), 0% (-),. 6% Φ; Closeness to realitywas assessed as good, specifically: 72% (++), 22% (+), 0% (-), 6% Φ. Conclusion: EASIE team-training endoscopic hemostasis has a high acceptance by the trainees. A prospective comparison between conventional endoscopic education and practical education in interventional endoscopy using EASIE will be done soon.