Search

Background and Aims: Postoperative pancreatic leakage and fistulae (POPF) are a leading adverse event after partial pancreatic resection. Treatment algorithms are currently not standardized. Evidence regarding the role of endoscopy is scarce., Methods: One hundred ninety-six POPF patients with (n = 132) and without (n = 64) concomitant pancreatic fluid collections (PFCs) from centers in Berlin, Kiel, and Dresden were analyzed retrospectively. Clinical resolution was used as the primary endpoint of analysis., Results: Analysis was stratified by the presence or absence of a PFC because these patients differed in treatment pathway and the presence of systemic inflammation with a median C-reactive protein of 30.7 mg/dL in patients without a PFC versus 131.0 mg/dL in patients with a PFC (P = 3.4 × 10 -4 ). In patients with PFCs, EUS-guided intervention led to resolution in a median of 8 days as compared with 25 days for percutaneous drainage and 248 days for surgery (P = 3.75 × 10 -14 ). There was a trend toward a higher success rate of EUS-guided intervention as a primary treatment modality with 85% (P = .034), followed by percutaneous drainage (64%) and surgery (41%). When applied as a rescue intervention (n = 24), EUS led to clinical resolution in 96% of cases. In patients without PFCs, EUS-guided internalization in a novel endoscopic technique led to resolution after a median of 4 days as compared with 51 days for a remaining surgical drainage (P = 9.3 × 10 -9 )., Conclusions: In this retrospective analysis, EUS-guided drainage of POPF led to a more rapid resolution. EUS may be considered as a viable option in the management of PFCs and POPF and should be evaluated in prospective studies., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections., Objective: To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD)., Design: Randomized, prospective, controlled, ex vivo study., Setting: Academic medical center., Methods: A total of 80 standardized artificial lesions measuring 3 × 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope., Main Outcome Measurements: An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate., Results: For the ESD novice, the mean submucosal dissection time (10.5 ± 3.8 vs 14.9 ± 7.3 minutes; P = .024) and total procedure time (18.1 ± 5.2 vs 23.6 ± 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 ± 6.0 minutes, conventional group 14.2 ± 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups., Limitations: Ex vivo study., Conclusion: In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

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., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

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., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage., Objective: We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage., Design: Randomized, controlled, ex-vivo study., Setting: Academic medical center., Methods: Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum)., Main Outcome Measurements: Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment., Results: All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested., Limitations: Ex-vivo study., Conclusions: In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: A novel, over-the-scope clip (OTSC) system may be suitable for closure of various GI perforations. The strength and maximum diameter of closure for a single OTSC, however, are unknown., Objective: To determine the maximum closure capacity (diameter) and pressure threshold for a single OTSC., Design: Prospective ex-vivo study., Setting: Academic medical center., Method: Full-thickness, standardized defects of 5 mm, 10 mm, 15 mm, 20 mm, and 25 mm were created in porcine stomachs. Similarly, full-thickness defects of 10 mm, 20 mm, 25 mm, 30 mm, and 35 mm were created in porcine colons. A single OTSC was endoscopically deployed 5 times for each full-thickness defect size in an ex-vivo endoscopic simulator., Main Outcome Measurements: Each closure site was tested under water with compressed air for burst pressure., Results: We achieved successful closure in all stomach defects ranging from 5 to 20 mm by using 12-mm OTSCs with short teeth and colon defects ranging from 10 to 30 mm with 14-mm OTSCs with short teeth. Mean (± standard deviation [SD]) burst pressures for the gastric closure sites were 74.9 ± 17.5 mm Hg for 15-mm defects, 49.3 ± 21.6 mm Hg for 20-mm defects, and 15.2 ± 4.1 mm Hg for 25-mm defects. Mean (± SD) burst pressures for the colon closure sites were 117.9 ± 40.1 mm Hg for 20-mm defects, 57.4 ± 4.2 mm Hg for 30-mm defects, and 10.9 ± 7.6 mm Hg for 35-mm defects., Limitations: Ex-vivo study, does not reflect difficult locations., Conclusion: Full-thickness tissue defects ranging from 5 to 20 mm in the stomach and from 10 to 30 mm in the colon can be closed adequately with a single OTSC in an ex-vivo experimental setting. Tissue defects larger than 20 mm in the stomach and 30 mm in the colon may require more than one OTSC or supplemental endoclips to achieve adequate closure. Endoscopic inspection of the closure site does not assure adequate closure of larger perforations., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Optimizing the visualization of the cutting line of the submucosal layer is essential to performing an effective and safe endoscopic submucosal dissection (ESD)., Objective: To evaluate the prototype R-scope compared with a conventional, double-channel endoscope in time required for ESD of mucosal lesions in distinct anatomical locations of the stomach., Design: A prospective, comparative, ex vivo study., Intervention: ESD., Main Outcome Measurements: Procedure time (primary end point measure), specimen size, submucosal injection frequency, en bloc resection rate, and perforation rate (secondary end point measures)., Results: In the subgroup of resections in the greater and lesser curvature, the mean (+/- SD) procedure time was significantly less in the R-scope group compared with the conventional endoscope group (8.4 +/- 2.1 minutes vs 11.3 +/- 2.1 minutes, respectively; P = .006), and the mean (+/- SD) submucosal injection frequency was significantly less in the R-scope group compared with the conventional endoscope group (1.9 +/- 0.6 vs 2.5 +/- 0.5, respectively; P = .025). There were no significant differences in procedure time, specimen size, submucosal injection requirements, en bloc resection rate, and perforation rate between the two endoscopic groups of all combined anatomic lesions., Limitations: Small, ex vivo study., Conclusion: ESD by using the R-scope may provide an improved platform for quicker ESD, especially in greater and lesser curvature anatomical lesions of the stomach., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: EUS-guided photodynamic therapy (PDT) with the photosensitizing agent porfimer sodium has been shown to be effective in ablation of pancreatic tissue., Objective: The objective of this study was to determine the effectiveness and safety of EUS PDT with verteporfin, a photosensitizer associated with less photosensitivity., Design: Prospective investigation of 6 swine that received an IV injection of 6 mg/m2 of verteporfin before EUS., Setting: Hospital animal laboratory., Interventions: The tail of the pancreas was located with EUS and was used to guide the placement of a light catheter. The pancreatic tail was exposed to 10, 15, or 20 minutes of laser light (689 nm)., Main Outcome Measurements: Follow-up abdominal CT, liver and renal function tests, and serum pancreatic enzymes levels were performed. Histology of the pancreas was obtained 7 days after the procedure on necropsy., Results: Localized tissue necrosis within the pancreatic tail (range 6.6-30.5 mm in diameter) was seen in all animals. The diameter of the necrotic tissue was directly related to the dose of light. No post-procedural complications were observed., Limitations: Normal animal model (lack of malignant tissue)., Conclusions: EUS-guided PDT of porcine pancreas with verteporfin achieved localized pancreatic tissue ablation in a dose-related fashion.

Background: In contrast to laparoscopic tubal ligation, oophorectomy, and appendectomy, laparoscopic distal pancreatectomy is associated with a morbidity rate of more than 50% and a mortality rate of more than 3%., Objective: To develop a minimally invasive, transgastric endoscopic technique for distal pancreatectomy in a nonsurvival series in swine., Design: Experimental study., Setting: Animal trial at a tertiary-care academic hospital., Subjects: Six healthy Yorkshire swine under general anesthesia., Interventions: A double-channel gastroscope was introduced into the stomach, and a gastric incision was created by using a triple-lumen, 4-mm, cutting-wire needle knife. The peritoneal cavity was accessed. An Endoloop was placed endoscopically around the distal aspect of the pancreas, and the tail of the pancreas was transected by using a diathermic snare. One to 3 hemoclips were placed across the pancreatic duct. The pancreatic specimen was retrieved, and the gastrotomy was closed endoscopically with metal clips. The animals were euthanized after the procedure. The abdominal cavity was examined grossly, and the resected pancreas was examined histologically., Main Outcome and Measurements: Feasibility of endoscopic transgastric distal pancreatectomy and rate of complications., Results: The pancreatic tail was successfully resected via a transgastric endoscopic approach in all animals. The procedure took an average (standard deviation) of 77.3 +/- 18.9 minutes. There was 1 complication, an episode of bleeding from a splenic laceration, which resulted in the loss of 250 mL of blood., Limitations: Nonsurvival series, animal study., Conclusions: Transgastric endoscopic distal pancreatectomy is technically feasible and can be performed in the porcine animal model.

Background: OncoGel (ReGel/paclitaxel) is an intralesional injectable formulation of the chemotherapeutic drug, paclitaxel, for local tumor management., Objective: The aim of this study was to determine if a minimally invasive EUS-guided injection of paclitaxel, bound to a thermosensitive gel carrier, would lead to therapeutic tissue concentrations of the chemotherapeutic agent in the porcine pancreas., Design: Eight Yorkshire breed pigs were sedated by general anesthesia and OncoGel was injected, under EUS-guidance, with a 22-gauge needle into the tail of the pancreas., Main Outcome Measurements: During the 7-day (n = 4) or 14-day (n = 4) observational period, the animals were monitored by serum levels of amylase and lipase, and by a CT on day 4. The outcome was determined by gross and microscopic evidence of inflammation of the pancreas, clinical tolerance, and quantitation of tissue paclitaxel concentrations., Results: Eight pigs underwent injection of 1, 2, 3, or 4 mL OncoGel (6 mg paclitaxel per 1 mL OncoGel) (n = 2 per group). An intrapancreatic hyperechoic focus, with an average diameter of 2.1 +/- 0.8 cm, was visible by EUS, and a hypodense area in the tail of the pancreas was visible by contrast CT. Clinically, the animals appeared to tolerate the procedure without sequelae. Blood levels of amylase and lipase were normal. At euthanasia, a depot of OncoGel, with an average diameter of 14.7 +/- 5.0 mm), was located both grossly and histologically in the pancreatic tail. After 14 days, clinically significant tissue concentrations of paclitaxel were detected at a distance of 30 to 50 mm from the depot in the animals that underwent an injection of 3 and 4 mL of the agent (n = 2)., Conclusions: The EUS-guided injection of OncoGel into the pancreas of the pig provided high and sustained localized concentrations of paclitaxel. This technique is a potential minimally invasive local treatment option for unresectable pancreatic tumors.

Background: Ethanol is a commonly available agent and has been used to successfully and safely ablate cystic lesions of various organs., Objective: The aim of this study was to determine the short-term effects of an EUS-guided injection of ethanol into the pancreas of pigs by using 2 mL ethanol, in increasing concentration of 0% to 100%., Design: Six pigs were sedated by general anesthesia, and ethanol was injected, under EUS-guidance, with a 22-gauge needle into the pancreatic tail., Main Outcome Measurements: End points of this study were gross and microscopic evidence of pancreatitis and clinical tolerance. During the 7-day observational period, the animals were monitored by serum levels of amylase and lipase and by a CT on day 4., Results: At euthanasia, there was no pancreatic lesion in the animals that received normal saline solution or 20% ethanol. The injection of 40% to 100% ethanol led to a visible necrotic area in the pancreatic tail. By histology, the average maximal diameter of the lesions was 20.8 +/- 4.3 mm. The cross-sectional area of necrosis was proportional to the concentration of ethanol (r = 0.961). CT demonstrated a localized site of nonenhancing pancreatic tissue, with an average diameter of 19.4 +/- 10.5 mm; 40% to 100% ethanol. Clinically, the animals appeared to tolerate the procedure without sequelae. Serum levels of amylase and lipase were normal., Conclusions: The EUS-guided injection of ethanol into the pig pancreas resulted in a localized concentration-dependent tissue necrosis without complications.

Background: Electronic 270 degrees transverse-array EUS (TA-EUS) provides high-quality cross-sectional images but cannot guide FNA. Linear EUS (L-EUS) provides longitudinal images of malignancies and the ability to guide FNA., Objective: We conducted a prospective randomized comparison of TA-EUS and L-EUS for the staging of upper-GI (UGI) malignancies., Design: Forty-three patients underwent L-EUS immediately followed by TA-EUS (N = 27, 63%) or TA-EUS immediately followed by L-EUS (N = 16, 37%)., Patients: Forty-three subjects (mean age, 64 years; 37 men) with an UGI malignancy (4 stomach and 38 esophageal) were evaluated with both TA-EUS and L-EUS., Interventions: Abnormal lymph nodes were sampled by FNA for cytology., Results: There was agreement on the T stage by linear and radial techniques in 38 of 43 subjects (88%). Twenty-seven of 43 patients (63%) had abnormal lymph nodes by linear or transverse-array imaging. L-EUS demonstrated 66 abnormal lymph nodes in 27 subjects (average of 2.4 nodes/subject). TA-EUS demonstrated 90 abnormal lymph nodes in 27 subjects (average of 3.3 nodes/subject, P = .009, compared with L-EUS). In 16 of the 27 subjects, an FNA was performed, which was positive in 13 cases (81%) and negative in 3 cases (10%) for malignancy., Conclusions: TA-EUS and L-EUS provide similar results of T staging of UGI malignancies. However, the number of abnormal lymph nodes detected by TA-EUS was more than by L-EUS. These findings suggest that radial or transverse-array EUS imaging should be the primary method for staging of UGI malignancies.

Background: Computer simulators, live pigs, and ex vivo porcine simulators are used for training in ERCP. The location of the porcine biliary orifice in the proximal duodenum is dissimilar to human anatomy, making the endoscopy experience less realistic. In addition, in native porcine anatomy, the pancreatic duct enters the duodenum distal to the biliary orifice, limiting the teaching of pancreatic techniques and selective duct cannulation., Objective: To overcome these limitations, we aimed to construct a Neo-Papilla that could be incorporated into an ex vivo model., Design: We attached chicken heart tissue to the porcine duodenum, with integrated porcine arteries that resembled an artificial common bile duct and a pancreatic duct., Setting: The simulator was presented and evaluated at 2 major GI endoscopy conferences., Main Outcome Measurements: The feasibility and the realism of this prototype was tested by 9 recognized ERCP experts who rated this model in comparison to other teaching models for ERCP by recollection of prior experience., Results: The Neo-Papilla was more prominent and more distally located than the native porcine papilla. The experts rated this modification superior to existing models in its usefulness as an educational tool., Limitations: Pilot study., Conclusions: We demonstrated the technical feasibility of a real-tissue Neo-Papilla modification of porcine ex vivo simulators, more closely approximating the natural anatomy. This new model should facilitate ERCP training. Formal validation studies are warranted.

Background: The efficacy of an intensive hands-on training in endoscopic hemostasis on the compactEASIE simulator has been previously demonstrated in a randomized prospective trial. In the current study, we evaluated how quickly and effectively new tutors, without simulator training experience, are able to acquire teaching skills in endoscopic hemostasis., Methods: Five tutors with prior Erlangen Active Simulator for Interventional Endoscopy (EASIE) teaching experience instructed 7 endoscopists without prior EASIE experience on how to teach when using the model. These new tutors then independently conducted a workshop for 8 fellows in 4 hemostasis techniques. Results were compared with a historical control trained similarly by experienced tutors. Two one-day workshops in endoscopic hemostasis on the compactEASIE ex vivo endoscopy simulator were conducted in a category A hospital in New York City, New York. Skill scores at the end of training were compared with baseline skills assessments, and qualitative ratings of the new tutors were obtained from both the trainees and the experienced tutors., Results: Significant improvement was achieved by the fellows in all 4 skills areas. Both the expert tutors and the trainees consistently rated the teaching skill of the new tutors highly. Fellows' skill acquisition using new tutors was of similar magnitude to that achieved in the prior EASIE trial using experienced trainers teaching the fellows., Conclusions: It is feasible to conduct an effective EASIE train-the-trainer course in one day. Tutors trained in this manner are able to provide a similar educational experience with objective improvement in trainee skill to experts who have conducted many hands-on workshops.

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.