Cost-effective modified endoscopic vacuum therapy for the treatment of gastrointestinal transmural defects: step-by-step process of manufacturing and its advantages.

Video 1Cost-effective modified endoscopic vacuum therapy for GI transmural defects. Step-by-step process of manufacturing and potential advantages.1.Cut half gauze to the ideal size to cover only the fenestrated portion of the nasogastric tube (NGT).2.Wrap the gauze around the fenestrated portion of the NGT. The assistance of another person is important in this process.3.Cut the antimicrobial incise drape to match the size of the fenestrated portion of the NGT. Note that the incise drape is a very strong adhesive; therefore, 3 people are usually required to assemble it properly.4.Next, the suture is used to fix the gauze and drape to the NGT. Perform fixation of the modified sponge in 3 places. The first knot is in the proximal portion, just below the last fenestra of the NGT, as a marker of where the vacuum system starts. The second knot is at the distal end, to avoid migration of the modified sponge. The third knot is in the middle of the modified sponge, which is essential to serve as a guide during endoscopic placement. For example, in cases of defects without collection in which the sponge will be placed in an intraluminal position, it is ideal to place the vacuum system in the middle of the defect; in cases of intracavitary placement, it will work as a guide to how much of the modified sponge will be inside the collection.5.Finally, use a needle to make innumerable punctures in the modified sponge system to obtain adequate aspiration. An 18G needle is recommended because, in addition to having an adequate diameter, it is very sharp, which facilitates perforation of the modified sponge system.6.After creation of the modified endoscopic vacuum therapy, the functionality test is performed. Turn on the wall suction system, connect the distal end of the NGT to the tube of the canister connected on the wall, and place the NGT inside a bowl with a liquid solution. The aspiration of a large amount of liquid indicates proper functioning of the modified endoscopic vacuum therapy system.7.The device is then ready to be positioned endoscopically in the patient. After proper positioning, connect the NGT to the suction tube to avoid migration of the device upon removal of the scope.8.In addition to the cost-effective device as described, in our practice we also use wall suction to reduce costs associated with the use of the vacuum machine.9.Use the antimicrobial incise drape to seal the connection between the NGT and the suction tube to avoid leakage within the connection.10.Last, owing to instability of the negative wall pressure, a 20F intravenous catheter is connected to the tube to maintain a negative pressure between -75 and -150 mmHg, as confirmed by laboratory studies performed by our group.

Sutureless Duodeno-Ileal Anastomosis with Self-Assembling Magnets: Safety and Feasibility of a Novel Metabolic Procedure.

BACKGROUND: Less invasive and safer anastomotic techniques are desirable. We aimed to determine technical feasibility and safety of sutureless duodeno-ileal side-to-side anastomosis in obese patients using self-assembling magnets. METHODS: This was an open-label, prospective, and single-arm study including obese patients (BMI 30-50 kg/m2) with type II diabetes. The ileal magnet was deployed laparoscopically, and the duodenal magnet was deployed endoscopically. Both magnets were coupled under laparoscopic and fluoroscopic guidance. The primary endpoints were technical feasibility and safety. The secondary endpoints were patency of the anastomosis, HbA1c reduction, and weight loss 12 months after the procedure. RESULTS: A total of 8 patients were enrolled in the study; median age was 51.5 years (range: 34-65), and median BMI was 38.8 kg/m2 (range: 35-47.9). The mean procedural duration was 63.5 min (range: 41-95). No intraoperative complications were recorded, and no major postoperative morbidity related to the procedure occurred. Magnets were expelled at a median of 29.5 days after the procedure with no associated complications. Upper endoscopy at 12 months confirmed patent anastomoses with healthy-appearing mucosa in all patients. HbA1c reduced below 7.0% in 6 out of 8 (75%) patients, and greater than 5% of total body weight loss was observed in 7 out of 8 (87.5%) patients at 12 months. CONCLUSIONS: Sutureless duodeno-ileal side-to-side anastomosis using self-assembling magnets is feasible and safe in obese patients, and a dual-path enteral diversion with large-caliber and durable anastomosis can be achieved.

Endoscopic ultrasound fine needle aspiration vs fine needle biopsy in solid lesions: A multi-center analysis.

BACKGROUND: While endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is considered a preferred technique for tissue sampling for solid lesions, fine needle biopsy (FNB) has recently been developed. AIM: To compare the accuracy of FNB vs FNA in determining the diagnosis of solid lesions. METHODS: A retrospective, multi-center study of EUS-guided tissue sampling using FNA vs FNB needles. Measured outcomes included diagnostic test characteristics (i.e., sensitivity, specificity, accuracy), use of rapid on-site evaluation (ROSE), and adverse events. Subgroup analyses were performed by type of lesion and diagnostic yield with or without ROSE. A multivariable logistic regression was also performed. RESULTS: A total of 1168 patients with solid lesions (n = 468 FNA; n = 700 FNB) underwent EUS-guided sampling. Mean age was 65.02 ± 12.13 years. Overall, sensitivity, specificity and accuracy were superior for FNB vs FNA (84.70% vs 74.53%; 99.29% vs 96.62%; and 87.62% vs 81.55%, respectively; P < 0.001). On subgroup analyses, sensitivity, specificity, and accuracy of FNB alone were similar to FNA + ROSE [(81.66% vs 86.45%; P = 0.142), (100% vs 100%; P = 1.00) and (88.40% vs 85.43%; P = 0.320]. There were no difference in diagnostic yield of FNB alone vs FNB + ROSE (P > 0.05). Multivariate analysis showed no significant predictor for better accuracy. On subgroup analyses, FNB was superior to FNA for non-pancreatic lesions; however, there was no difference between the techniques among pancreatic lesions. One adverse event was reported in each group. CONCLUSION: FNB is superior to FNA with equivalent diagnostic test characteristics compared to FNA + ROSE in the diagnosis of non-pancreatic solid lesions. Our results suggest that EUS-FNB may eliminate the need of ROSE and should be employed as a first-line method in the diagnosis of solid lesions.

Risk factors for gastroesophageal reflux after POEM for achalasia: a systematic review and meta-analysis.

INTRODUCTION: Peroral endoscopic myotomy (POEM) demonstrated similar efficacy to surgical myotomy in the management of achalasia. However, gastroesophageal reflux disease (GERD) is common after POEM. The aim of this study is to identify factors associated with GERD after POEM. METHOD: After searching electronic databases, randomized trials and observational studies including patients with achalasia or other spastic esophageal disorders, treated by POEM, and providing GERD data were selected. GERD was evaluated by 3 methods: pH monitoring, endoscopic findings, and symptoms. For each method, an analysis was performed comparing the outcomes related to the following independent variables: full-thickness (FT) vs circular myotomy, anterior vs posterior, long myotomy vs short myotomy, naive vs previous treatment failure, previous Heller myotomy (HM) vs non-previous-HM, Type I vs II, Type I vs III, and Type II vs III. RESULTS: 2869 publications were identified, and 25 studies met criteria for inclusion in the qualitative analysis. Of these, 18 were included in the meta-analysis. According to the endoscopic findings, circular and anterior myotomy demonstrated a lower trend of GERD with borderline significance (p = 0.06; p = 0.07, respectively). In the pH monitoring and symptom analyses, circular myotomy, anterior myotomy, treatment naive, and non-HM patients were associated with a lower occurrence of GERD; however, no statistically significant difference was found. When comparing achalasia subtypes, no statistical difference was found in all analyses. CONCLUSION: This systematic review and meta-analysis suggest that a circular anterior approach may limit post-POEM GERD and should be considered in appropriate patients.

Gastrointestinal Manifestations and Associated Health Outcomes of COVID-19: A Brazilian Experience From the Largest South American Public Hospital.

OBJECTIVES: Brazil has rapidly developed the second-highest number of COVID-19 cases in the world. As such, proper symptom identification, including gastrointestinal manifestations, and relationship to health outcomes remains key. We aimed to assess the prevalence and impact of gastrointestinal symptoms associated with COVID-19 in a large quaternary referral center in South America. METHODS: This was a single-center cohort study in a COVID-19 specific hospital in São Paulo, Brazil. Consecutive adult patients with laboratory confirmed SARS-CoV-2 were included. Baseline patient history, presenting symptoms, laboratory results, and clinically relevant outcomes were recorded. Regression analyses were performed to determine significant predictors of the gastrointestinal manifestations of COVID-19 and hospitalization outcomes. RESULTS: Four-hundred patients with COVID-19 were included. Of these, 33.25% of patients reported ≥1 gastrointestinal symptom. Diarrhea was the most common gastrointestinal symptom (17.25%). Patients with gastrointestinal symptoms had higher rates of concomitant constitutional symptoms, notably fatigue and myalgia (p<0.05). Gastrointestinal symptoms were also more prevalent among patients on chronic immunosuppressants, ACE/ARB medications, and patient with chronic kidney disease (p<0.05). Laboratory results, length of hospitalization, ICU admission, ICU length of stay, need for mechanical ventilation, vasopressor support, and in-hospital mortality did not differ based upon gastrointestinal symptoms (p>0.05). Regression analyses showed older age [OR 1.04 (95% CI, 1.02-1.06)], male gender [OR 1.94 (95% CI, 1.12-3.36)], and immunosuppression [OR 2.60 (95% CI, 1.20-5.63)], were associated with increased mortality. CONCLUSION: Based upon this Brazilian study, gastrointestinal manifestations of COVID-19 are common but do not appear to impact clinically relevant hospitalization outcomes including the need for ICU admission, mechanical ventilation, or mortality.

Diagnostic Characteristics of Serological-Based COVID-19 Testing: A Systematic Review and Meta-Analysis.

Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promises to assist in assessing exposure to and confirming the diagnosis of coronavirus disease 2019 (COVID-19), and to provide a roadmap for reopening countries worldwide. Considering this, a proper understanding of serologic-based diagnostic testing characteristics is critical. The aim of this study was to perform a structured systematic review and meta-analysis to evaluate the diagnostic characteristics of serological-based COVID-19 testing. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. Full-text observational studies that reported IgG or IgM diagnostic yield and used nucleic acid amplification tests (NAATs) of respiratory tract specimens, as a the reference standard in English language were included. A bivariate model was used to compute pooled sensitivity, specificity, positive/negative likelihood ratio (LR), diagnostic odds ratio (OR), and summary receiver operating characteristic curve (SROC) with corresponding 95% confidence intervals (CIs). Five studies (n=1,166 individual tests) met inclusion criteria. The pooled sensitivity, specificity, and diagnostic accuracy for IgG was 81% [(95% CI, 61-92);I2=95.28], 97% [(95% CI, 78-100);I2=97.80], and 93% (95% CI, 91-95), respectively. The sensitivity, specificity, and accuracy for IgM antibodies was 80% [(95% CI, 57-92);I2=94.63], 96% [(95% CI, 81-99);I2=92.96] and 95% (95% CI, 92-96). This meta-analysis demonstrates suboptimal sensitivity and specificity of serologic-based diagnostic testing for SARS-CoV-2 and suggests that antibody testing alone, in its current form, is unlikely to be an adequate solution to the difficulties posed by COVID-19 and in guiding future policy decisions regarding social distancing and reopening of the economy worldwide.

Approach to Endoscopic Procedures: A Routine Protocol from a Quaternary University Referral Center Exclusively for Coronavirus Disease 2019 Patients.

OBJECTIVES: The present coronavirus disease (COVID-19) pandemic has ushered in an unprecedented era of quality control that has necessitated advanced safety precautions and the need to ensure the adequate protection of healthcare professionals (HCPs). Endoscopy units, endoscopists, and other HCP may be at a significant risk for transmission of the virus. Given the immense burden on the healthcare system and surge in the number of patients with COVID-19, well-designed protocols and recommendations are needed. We aimed to systematically characterize our approach to endoscopic procedures in a quaternary university hospital setting and provide summary protocol recommendations. METHOD: This descriptive study details a COVID-19-specific protocol designed to minimize infection risks to patients and healthcare workers in the endoscopy unit. RESULTS: Our institution, located in São Paulo, Brazil, includes a 900-bed hospital, with a 200-bed-specific intensive care unit exclusively designed for patients with moderate and severe COVID-19. We highlighted recommendations for infection prevention and control during endoscopic procedures, including appropriate triage and screening, outpatient management and procedural recommendations, role and usage of personal protective equipment (PPE), and role and procedural logistics involving COVID-19-positive patients. We also detailed hospital protocols for reprocessing endoscopes and cleaning rooms and also provided recommendations to minimize severe acute respiratory syndrome coronavirus 2 transmission. CONCLUSION: This COVID-19-specific administrative and clinical protocol can be replicated or adapted in multiple institutions and endoscopy units worldwide. Furthermore, the recommendations and summary protocol may improve patient and HCP safety in these trying times.

Novel Endoscopic Management of a Chronic Gastro-Gastric Fistula Using a Cardiac Septal Defect Occluder.

PURPOSE: Closure of GG fistulas after RYGB is challenging due to epithelialization of the tract. Common endoscopic therapies are less efficacious than surgical revision, which is unfortunately fraught with high morbidity and mortality. Cardiac septal defect occluders (CSDO) have been successfully used for the management of gastrointestinal fistulas, but use has never been reported in management of GG fistulas. Thus, we describe the first off-label use of CSDO for the treatment of a GG fistula. MATERIALS AND METHODS: Endoscopy and fluoroscopic examination determined the appropriate size of CSDO for closure. A guidewire was placed in the remnant stomach followed by placement of the delivery system. Then, under fluoroscopy, we deployed the first flange of the CSDO in the remnant stomach. Then, under fluoroscopy and endoscopic visualization, the second flange is deployed in the gastric pouch. RESULTS: A 51-year-old woman, status-post RYGB in 2008, presented with a 6-month history of weight regain and reflux. She had regained weight to 84 kg (BMI = 32 kg/m2) when she was found to have a GG fistula. She underwent successful CSDO placement and, 3 months later, had lost 10 kg with significant improvement in her reflux. Repeat evaluation confirmed successful fistula closure. CONCLUSION: The use of CSDO was technically feasible and appeared to be effective and safe. Future studies should continue to investigate the role of CSDO in management of this challenging condition.

Gallbladder perforation due to endoscopic sleeve gastroplasty: A case report and review of literature.

BACKGROUND: The healthcare impact of obesity is enormous, and there have been calls for new approaches to containing the epidemic worldwide. Minimally invasive procedures have become more popular, with one of the most widely used being endoscopic sleeve gastroplasty (ESG). Although major adverse events after ESG are rare, some can cause considerable mortality. To our knowledge, there has been no previous report of biliary ascites after ESG. CASE SUMMARY: A 48-year-old female with obesity refractory to lifestyle changes and prior gastric balloon placement underwent uncomplicated ESG and was discharged on the following day. On postoperative day 3, she developed abdominal pain, which led to an emergency department visit the following day. She was readmitted to the hospital, with poor general health status and signs of peritoneal irritation. Computed tomography imaging showed fluid in the abdominal cavity. Laparoscopy revealed biliary ascites and showed that the gallbladder was sutured to the gastric wall. The patient underwent cholecystectomy and lavage of the abdominal cavity and was admitted to the intensive care unit post-operatively. After 7 d of antibiotic therapy and 20 d of hospitalization, she was discharged. Fortunately, 6 mo later, she presented in excellent general condition and with a 20.2% weight loss. CONCLUSION: ESG is a safe procedure. However, adverse events can still occur, and precautions should be taken by the endoscopist. In general, patient position, depth of tissue acquisition, location of stitch placement, and endoscopist experience are all important factors to consider to mitigate procedural risk.

Endoscopic sleeve gastroplasty in the management of weight regain after sleeve gastrectomy.

BACKGROUND: Sleeve gastrectomy is a well-standardized surgical treatment for obesity. However, rates of weight regain after sleeve gastrectomy in long-term follow-up are relatively high. This multicenter study is the first to evaluate the use of an endoscopic sleeve gastroplasty (ESG) technique for the management of this population. METHODS: This was a multicenter retrospective study, including patients with weight regain following sleeve gastrectomy who underwent ESG for weight loss. Primary outcomes included absolute weight loss, percent total weight loss (%TWL), change in body mass index (BMI), percent excess weight loss (%EWL) at 6 and 12 months, and safety profile. Clinical success was defined as achieving ≥ 25 % EWL at 1 year, ≤ 5 % serious adverse event (SAE) rate following society-recommended thresholds, and %TWL ≥ 10 %. RESULTS: 34 patients underwent ESG after sleeve gastrectomy. Technical success was 100 %. At 1 year, 82.4 % and 100 % of patients achieved ≥ 10 %TWL and ≥ 25 % EWL, respectively. Mean (SD) %TWL was 13.2 % (3.9) and 18.3 % (5.5), and %EWL was 51.9 % (19.1) and 69.9 % (29.9) at 6 months and 1 year, respectively. Mean (SD) %TWL was 14.2 % (12.5), 19.3 % (5.3), 17.5 % (5.2), and 20.4 % (3.3), and %EWL was 88.5 % (52.8), 84.4 % (22.4), 55.4 % (14.8), and 47.8 % (11.2) for BMI categories of overweight and obesity class I, II, and III, respectively, at 1 year. No predictors of success were identified in the multivariable regression analysis. No SAEs were reported. CONCLUSION: ESG appears to be safe and effective in the management of weight regain following sleeve gastrectomy.

Gastrointestinal manifestations and associated health outcomes of COVID-19: a brazilian experience from the largest south american public hospital

OBJECTIVES: Brazil has rapidly developed the second-highest number of COVID-19 cases in the world. As such, proper symptom identification, including gastrointestinal manifestations, and relationship to health outcomes remains key. We aimed to assess the prevalence and impact of gastrointestinal symptoms associated with COVID-19 in a large quaternary referral center in South America. METHODS: This was a single-center cohort study in a COVID-19 specific hospital in São Paulo, Brazil. Consecutive adult patients with laboratory confirmed SARS-CoV-2 were included. Baseline patient history, presenting symptoms, laboratory results, and clinically relevant outcomes were recorded. Regression analyses were performed to determine significant predictors of the gastrointestinal manifestations of COVID-19 and hospitalization outcomes. RESULTS: Four-hundred patients with COVID-19 were included. Of these, 33.25% of patients reported ≥1 gastrointestinal symptom. Diarrhea was the most common gastrointestinal symptom (17.25%). Patients with gastrointestinal symptoms had higher rates of concomitant constitutional symptoms, notably fatigue and myalgia (p<0.05). Gastrointestinal symptoms were also more prevalent among patients on chronic immunosuppressants, ACE/ARB medications, and patient with chronic kidney disease (p<0.05). Laboratory results, length of hospitalization, ICU admission, ICU length of stay, need for mechanical ventilation, vasopressor support, and in-hospital mortality did not differ based upon gastrointestinal symptoms (p>0.05). Regression analyses showed older age [OR 1.04 (95% CI, 1.02-1.06)], male gender [OR 1.94 (95% CI, 1.12-3.36)], and immunosuppression [OR 2.60 (95% CI, 1.20-5.63)], were associated with increased mortality. CONCLUSION: Based upon this Brazilian study, gastrointestinal manifestations of COVID-19 are common but do not appear to impact clinically relevant hospitalization outcomes including the need for ICU admission, mechanical ventilation, or mortality.

Diagnostic characteristics of serological-based COVID-19 testing: a systematic review and meta-analysis

Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promises to assist in assessing exposure to and confirming the diagnosis of coronavirus disease 2019 (COVID-19), and to provide a roadmap for reopening countries worldwide. Considering this, a proper understanding of serologic-based diagnostic testing characteristics is critical. The aim of this study was to perform a structured systematic review and meta-analysis to evaluate the diagnostic characteristics of serological-based COVID-19 testing. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. Full-text observational studies that reported IgG or IgM diagnostic yield and used nucleic acid amplification tests (NAATs) of respiratory tract specimens, as a the reference standard in English language were included. A bivariate model was used to compute pooled sensitivity, specificity, positive/negative likelihood ratio (LR), diagnostic odds ratio (OR), and summary receiver operating characteristic curve (SROC) with corresponding 95% confidence intervals (CIs). Five studies (n=1,166 individual tests) met inclusion criteria. The pooled sensitivity, specificity, and diagnostic accuracy for IgG was 81% [(95% CI, 61-92);I2=95.28], 97% [(95% CI, 78-100);I2=97.80], and 93% (95% CI, 91-95), respectively. The sensitivity, specificity, and accuracy for IgM antibodies was 80% [(95% CI, 57-92);I2=94.63], 96% [(95% CI, 81-99);I2=92.96] and 95% (95% CI, 92-96). This meta-analysis demonstrates suboptimal sensitivity and specificity of serologic-based diagnostic testing for SARS-CoV-2 and suggests that antibody testing alone, in its current form, is unlikely to be an adequate solution to the difficulties posed by COVID-19 and in guiding future policy decisions regarding social distancing and reopening of the economy worldwide.

Approach to endoscopic procedures: a routine protocol from a quaternary university referral center exclusively for coronavirus disease 2019 patients

OBJECTIVES: The present coronavirus disease (COVID-19) pandemic has ushered in an unprecedented era of quality control that has necessitated advanced safety precautions and the need to ensure the adequate protection of healthcare professionals (HCPs). Endoscopy units, endoscopists, and other HCP may be at a significant risk for transmission of the virus. Given the immense burden on the healthcare system and surge in the number of patients with COVID-19, well-designed protocols and recommendations are needed. We aimed to systematically characterize our approach to endoscopic procedures in a quaternary university hospital setting and provide summary protocol recommendations. METHOD: This descriptive study details a COVID-19-specific protocol designed to minimize infection risks to patients and healthcare workers in the endoscopy unit. RESULTS: Our institution, located in São Paulo, Brazil, includes a 900-bed hospital, with a 200-bed-specific intensive care unit exclusively designed for patients with moderate and severe COVID-19. We highlighted recommendations for infection prevention and control during endoscopic procedures, including appropriate triage and screening, outpatient management and procedural recommendations, role and usage of personal protective equipment (PPE), and role and procedural logistics involving COVID-19-positive patients. We also detailed hospital protocols for reprocessing endoscopes and cleaning rooms and also provided recommendations to minimize severe acute respiratory syndrome coronavirus 2 transmission. CONCLUSION: This COVID-19-specific administrative and clinical protocol can be replicated or adapted in multiple institutions and endoscopy units worldwide. Furthermore, the recommendations and summary protocol may improve patient and HCP safety in these trying times.