Ligation-assisted endoscopic mucosal resection for esophageal granular cell tumors is safe and effective.

Given their malignant potential, resection of esophageal granular cell tumors (GCTs) is often undertaken, yet the optimal technique is unknown. We present a large series of dedicated endoscopic resection using band ligation (EMR-B) of esophageal GCTs. Patients diagnosed with esophageal GCTs between 2002 and 2019 were identified using a prospectively collected pathology database. Endoscopic reports were reviewed, and patients who underwent dedicated EMR-B of esophageal GCTs were included. Medical records were queried for demographics, findings, adverse events, and follow-up. We identified 21 patients who underwent dedicated EMR-B for previously identified esophageal GCT. Median age was 39 years; 16 (76%) were female. Eight (38%) had preceding signs or symptoms, potentially attributable to the GCT. Upon endoscopic evaluation, 12 (57%) were found in the distal esophagus. Endoscopic ultrasound was used in 15 cases (71%). Median lesion size was 7 mm, interquartile range 4 mm-8 mm. The largest lesion was 12 mm. A total of 20 (95%) had en bloc resection confirmed with pathologic examination. The only patient with tumor extending to the resection margin underwent surveillance endoscopy that showed no residual tumor. No patients experienced bleeding, perforation, or stricturing in our series. No patients have had known recurrence of their esophageal GCT. EMR-B of esophageal GCT achieves complete histopathologic resection with minimal adverse events. EMR-B is safe and effective and seems prudent compared with observation for what could be an aggressive and malignant tumor. EMR-B should be considered first-line therapy when resecting esophageal GCT up to 12 mm in diameter.

Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.

Endoscopic Therapy is Effective for Recurrent Anastomotic Biliary Strictures after Orthotopic Liver Transplantation.

INTRODUCTION: Orthotopic liver transplantation anastomotic biliary strictures (OLT ABS) are managed with endoscopic biliary stent therapy but the recurrence rate is substantial. Our aims were to retrospectively determine the recurrence rates of OLT ABS after initial successful stent therapy, characterize the management of recurrences and identify associated variables. MATERIALS AND METHODS: Clinical data from 943 patients receiving non-living donor OLT at our institution from 2005-2012 were reviewed, and 123 OLT ABS patients receiving stent therapy were identified. Features of their endoscopic stent therapy and other pertinent clinical information were evaluated. RESULTS: ABS recurred in 25.5% of patients (24/94) after an initial successful course of stent therapy. Recurrences were received a second course of endoscopic stent therapy and 67% of patients (16/24) achieved long-term remediation of ABS. Six patients underwent a third course of endoscopic stent therapy with 4 patients achieving remediation. Overall remediation rate among ABS recurrences was 83.3% (20/24). A bivariate comparison demonstrated HCV infection, age, median months of maximal stenting and a lower maximum cumulative stent diameter were risk factors for ABS recurrence. Using a Cox regression model, only HCV status proved to be a risk factor for recurrence. DISCUSSION: In conclusion repeat stent therapy achieved high stricture remediation rates. Recurrence after the first or even second course of stenting should not imply failure of endoscopic therapy. A positive HCV status may be associated with higher stricture recurrence rates and this association should be further investigated.

Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.

OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. RESULTS: At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. CONCLUSIONS: The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Therapeutic Endoscopy for the Control of Nonvariceal Upper Gastrointestinal Bleeding in Children: A Case Series.

OBJECTIVES: Gastrointestinal bleeding is one of the most common indications for urgent endoscopy in the pediatric setting. The majority of these procedures are performed for control of variceal bleeding, with few performed for nonvariceal upper gastrointestinal (NVUGI) bleeding. The data on therapeutic endoscopy for NVUGI are sparse. The aims of our study were to review our experience with NVUGI bleeding, describe technical aspects and outcomes of therapeutic endoscopy, and determine gastroenterology fellows' training opportunities according to the national training guidelines. METHODS: We performed a retrospective review of endoscopy database (Endoworks, Olympus Inc, Center Valley, PA) from January 2009 to December 2014. The search used the following keywords: bleeding, hematemesis, melena, injection, epinephrine, cautery, clip, and argon plasma coagulation. The collected data included demographics, description of bleeding lesion and medical/endoscopic therapy, rate of rebleeding, relevant laboratories, physical examination, and need for transfusion and surgery. The study was approved by the institutional review board. RESULTS: During the study period 12,737 upper endoscopies (esophagogastroduodenoscopies) were performed. A total of 15 patients underwent 17 esophagogastroduodenoscopies that required therapeutic intervention to control bleeding (1:750 procedures). The mean ±â€Šstandard deviation (median) age of patients who required endoscopic intervention was 11.6 ±â€Š6.0 years (14.0 years). Seven out of 17 patients received dual therapy to control the bleeding lesions. All but 3 patients received medical therapy with intravenous proton pump inhibitor, and 3 received octreotide infusions. Six of the patients experienced rebleeding (40%), with 4 out of 6 initially only receiving single modality therapy. Two of these patients eventually required surgical intervention to control bleeding and both patients presented with bleeding duodenal ulcers. There were no cases of aspiration, perforation, or deaths. There were a total of 24 fellows trained in our program during the study period. Less than 1 therapeutic endoscopy per fellow for NVUGI bleeding was performed. CONCLUSIONS: NVUGI bleeding requiring therapeutic endoscopic intervention is rare in pediatrics. A high rate (40%) of rebleeding was noted with a large proportion (66%) of patients receiving single modality therapy. Two patients required surgical intervention to control bleeding and both presented with bleeding duodenal ulcers. An insufficient number of therapeutic procedures is available for adequate fellow training requiring supplemental simulator and hands-on animal model, or adult endoscopy unit training.

Endoscopic retrograde cholangiopancreatography in the pediatric population is safe and efficacious.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is increasingly being used in the evaluation and management of biliary and pancreatic disorders in children. The aim of this study was to review the pediatric ERCP experience of a large academic referral center affiliated with a tertiary care children's hospital. METHODS: This is a retrospective review of medical records, endoscopic and operative reports, and radiography of those patients ages 0 to 21 years who underwent ERCP for any indication between 1993 and 2011 at a tertiary referral center affiliated with a large urban pediatric hospital. ERCP technical success was defined as cannulation of the desired duct. Serious adverse events included bleeding, perforation, pancreatitis, or death. RESULTS: Four hundred twenty-nine ERCPs were performed on 296 patients. The mean age was 14.9 ± 4.8 years (3 months-21 years); 51.1% were boys. Patients with a history of previous liver transplant comprised 13.1% (56) of all ERCPs. Abnormal liver chemistries or suspected choledocholithiasis accounted for half of the indications. A therapeutic intervention was performed in 64.1%. Technical success was achieved in 95.2% of ERCPs. Serious adverse events occurred in 7.7%. CONCLUSIONS: Pediatric ERCP is highly efficacious in the pediatric population, with the rates of technical success and use of therapeutic interventions mirroring those in adults. There is a low overall rate of serious adverse events. The overall efficacy and safety support the performance of pediatric ERCP by experienced endoscopists at high-volume centers.

Poor discriminatory function for endoscopic skills on a computer-based simulator.

BACKGROUND: Computer-based endoscopy simulators may enable trainees to learn and develop technical skills before performing on patients. Simulators require validation as adequate models of live endoscopy before being used for training or assessment purposes. OBJECTIVE: To evaluate content and criterion validity of the CAE EndoscopyVR Simulator colonoscopy and EGD modules as predictors of clinical endoscopic skills. DESIGN: Prospective, observational, non-randomized, parallel cohort study. SETTING: Single academic center with accredited gastroenterology training program. PARTICIPANTS: Five novice first-year gastroenterology fellows and 6 expert gastroenterology attending physicians. INTERVENTION: Participants performed 18 simulated colonoscopies and 6 simulated EGDs. The simulator recorded objective performance parameters. Participants then completed feedback surveys. MAIN OUTCOME MEASUREMENTS: The 57 objective performance parameters measured by the endoscopy simulator were compared between the two study groups. Novice and expert survey responses were analyzed. RESULTS: Significant differences between novice and expert performance were detected in only 19 of 57 (33%) performance metrics. Eight of these 19 (42%) were time-related metrics, such as total procedure time, time to anatomic landmarks, and time spent in contact with GI mucosa. Of 49 non-time related measures, the few additional statistically significant differences between novices and experts involved air insufflation, sedation management, endoscope force, and patient comfort. These findings are of uncertain clinical significance. Survey data found multiple aspects of the simulation to be unrealistic compared with human endoscopy. LIMITATIONS: Small sample size. CONCLUSION: The CAE EndoscopyVR Simulator displays poor content and criterion validity and is thereby incapable of predicting skill during in vivo endoscopy.

Lack of a discriminatory function for endoscopy skills on a computer-based simulator.

BACKGROUND: Computer-based endoscopy simulators have been developed to enable trainees to learn and gain technical endoscopic skills before operating on patients. However, these simulators have not been validated as models of patient-based endoscopy. This study aimed to determine whether a computer-based simulator can accurately represent an actual esophagogastroduodenoscopy (EGD) and colonoscopy and to evaluate its ability to discriminate between varying levels of expertise in performing endoscopic procedures based on objective parameters. METHODS: In a prospective, observational trial, five first-year gastroenterology fellows and six gastroenterology attendings from a single academic center completed six endoscopy cases on the Simbionix GI Mentor II endoscopy simulator. The cases were selected to represent common clinical scenarios. The performance parameters were collected by the simulator. The 13 performance parameters measured by the endoscopy simulator were compared between the two study groups. After the simulator cases, the participants completed a survey evaluating the realism of the simulator. RESULTS: Novices and experts were able to complete the tasks in the simulated cases with no significant overall differences between the two groups. The computer-based simulator was able to discriminate levels of expertise only for parameters related to the time spent on the procedure (total time, time to reach the second duodenum, time to reach the cecum, and efficiency of screening). No statistically significant differences were found for the other nine performance parameters measured by the simulator. Based on the survey data, expert opinion concluded that the simulator does not offer a realistic simulation of human endoscopy. CONCLUSIONS: The computer-based endoscopy simulator displays a lack of ability to discriminate between novices and experts in terms of endoscopic skills based on measured objective performance parameters. The findings of this study suggest that the computer-based simulator lacks fidelity and that upgrades are necessary to increase the simulator's ability to reproduce human endoscopy more accurately.

Impact of capsule endoscopy findings on patient outcomes.

BACKGROUND AND AIMS: There is limited data on the impact of capsule endoscopy (CE) findings on patient outcomes. The aim of our study is to evaluate the impact of CE findings on further diagnostic work-up, treatment, and symptom resolution. METHODS: A retrospective chart review of patients who underwent CE at a single tertiary care center over a 3-year period was performed. CE findings were classified as positive, suspicious, or negative. Therapeutic interventions were medical, endoscopic, surgical, other, or none. Symptoms were considered resolved when the patient had cessation of symptoms for at least 6 months post-CE. RESULTS: A total of 193 patients were studied. The overall diagnostic yield of CE was 37%. There were 97 (50%) patients who had further diagnostic testing following CE; (40 with positive, 22 with suspicious, 35 with negative CE findings). There were 76% patients who received treatment post-CE (59% with positive, 43% with suspicious, 49% with negative CE findings). Overall symptom resolution was seen in 71% of patients (59% with positive, 68% with suspicious, 70% with negative CE findings). There was no statistically significant difference in diagnostic work-up, treatment, and symptom resolution between patients with positive, suspicious, and negative findings. Patients with obscure overt GI bleeding were less likely to have further diagnostic work-up (P = 0.001), and had the highest rate of symptom resolution as compared to other indications (P < 0.001). CONCLUSIONS: There is no significant difference in outcomes amongst patients with positive, suspicious, and negative CE findings. Patients with obscure overt GI bleeding had more favorable outcomes as compared to other indications.

Minimizing complications in endoscopic retrograde cholangiopancreatography and sphincterotomy.

Endoscopic retrograde cholangiopancreatography (ERCP) is a major tool in the diagnosis and management of numerous biliary and pancreatic conditions, including choledocholithiasis as well as benign and malignant pancreatic diseases, especially those causing biliary obstruction. Since the procedure's inception, the techniques and indications have evolved along with advances in technology and an improved understanding of risks associated with ERCP. The trend has been away from purely diagnostic procedures; most ERCPs are now therapeutic in intent. ERCP remains among the more invasive of endoscopic procedures, with significant rates of complications that can be major. As advances are made in less invasive technology, it is important to understand the complications of ERCP and how best to avoid them.

Predictive validity of driving-simulator assessments following traumatic brain injury: a preliminary study.

OBJECTIVE: To evaluate whether driving simulator and road test evaluations can predict long-term driving performance, we conducted a prospective study on 11 patients with moderate to severe traumatic brain injury. Sixteen healthy subjects were also tested to provide normative values on the simulator at baseline. METHOD: At their initial evaluation (time-1), subjects' driving skills were measured during a 30-minute simulator trial using an automated 12-measure Simulator Performance Index (SPI), while a trained observer also rated their performance using a Driving Performance Inventory (DPI). In addition, patients were evaluated on the road by a certified driving evaluator. Ten months later (time-2), family members observed patients driving for at least 3 hours over 4 weeks and rated their driving performance using the DPI. RESULTS: At time-1, patients were significantly impaired on automated SPI measures of driving skill, including: speed and steering control, accidents, and vigilance to a divided-attention task. These simulator indices significantly predicted the following aspects of observed driving performance at time-2: handling of automobile controls, regulation of vehicle speed and direction, higher-order judgment and self-control, as well as a trend-level association with car accidents. Automated measures of simulator skill (SPI) were more sensitive and accurate than observational measures of simulator skill (DPI) in predicting actual driving performance. To our surprise, the road test results at time-1 showed no significant relation to driving performance at time-2. CONCLUSION: Simulator-based assessment of patients with brain injuries can provide ecologically valid measures that, in some cases, may be more sensitive than a traditional road test as predictors of long-term driving performance in the community.

Stepping over obstacles to improve walking in individuals with poststroke hemiplegia.

For this study, we evaluated two training interventions for improving gait parameters in individuals with poststroke hemiplegia using a training methodology that required them to step over objects. Gait velocity, step length, ability to step over obstacles, and walking endurance were compared before and after 2 weeks of training and 2 weeks after cessation of training. Twenty subjects with poststroke hemiplegia completed six intervention sessions in which they were asked to step over either virtual objects while walking on a motorized treadmill or real foam objects on a 10 m walkway. With the virtual object training, if either foot collided with the virtual object, a tone sounded and a vibrotactile stimulus was applied to the colliding foot. All subjects tolerated the training sessions well, and no incidences of falling or undue cardiovascular responses occurred. The virtual obstacle training generated greater improvements in gait velocity compared with real training (20.5% vs. 12.2% improvement) during the fast walk test (p < 0.01). Improvements in gait velocity for both training methods were similar in the self-selected walk test (33.3% vs. 34.7% improvement). Overall, subjects showed clinically meaningful changes in gait velocity, stride length, walking endurance, and obstacle clearance capacity as a result of either training method. These changes persisted for 2 weeks posttraining. The inclusion of enhanced safety and visual augmentation may be responsible for the effectiveness of the virtual object intervention. These results demonstrate preliminary evidence for clinical effectiveness of obstacle training for improving gait velocity poststroke. In addition, these results provide evidence for enhanced clinical performance with virtual obstacle training.

Endoscopic diagnosis of bleeding Meckel's diverticulum in a multivisceral transplant recipient.

Small bowel transplantation has become a life-saving procedure for patients with intestinal failure who fail conventional therapy. Meckel's diverticulum is a rare cause of occult gastrointestinal bleeding that has not been reported in patients receiving intestinal allografts. We report a case in which transplantation of an asymptomatic Meckel's diverticulum as part of a multivisceral allograft led to intestinal bleeding requiring surgical intervention. Endoscopy identified the actual bleeding diverticulum. Diverticulectomy at the time of transplant was not performed due to the difficult operative course, and the need for frequent surveillance ileoscopy, which would be performed across a fresh intestinal anastomosis. The patient underwent resection of the diverticulum, along with 40 cm of ileum, and did not experience further bleeding.