Endoscopic vacuum assisted wound closure (EVAC) device to treat esophageal and gastric leaks: assessing time to proficiency and cost.

BACKGROUND: Endoluminal vacuum therapy (EVAC) is an emerging procedure used to treat anastomotic leaks and/or perforations that would otherwise require surgery. The aim of this study was to determine time to proficiency in EVAC and the cost effectiveness of the procedure. METHODS: We retrospectively reviewed a prospectively maintained IRB approved database for all patients undergoing EVAC after esophageal and gastric complications between October 2013 and December 2017. Proficiency was determined by obtaining predicted estimates and analyzing the point at which average procedure time plateaued based on case volume. Total cost was calculated based on supplies and location where the procedure was performed. RESULTS: There were 50 patients (17 males, 33 female), with a mean age of 52.1 years. EVAC was placed in 23 (46%) patients with esophageal injuries and 28 (56%) with gastric injuries. Two advanced endoscopists performed all EVAC procedures in this study (1 surgeon, 1 gastroenterologist). The average procedure time for all patients was 43.5 min and the average wheel in/wheel out time for all patients was 75.6 min. Analysis of the trend based on average procedure times for EVAC revealed that proficiency was obtained after 10 cases. Total cost of the procedure is significantly lower in the GI lab compared to the operating room ($4528 vs. $11889). The majority of EVAC were performed in the GI lab (62%) compared to the operating room (38%). CONCLUSION: Successful outcomes in managing anastomotic leaks or intestinal perforations non-operatively has led to an increased interest in EVAC. For advanced endoscopists, time to proficiency is approximately 10 cases. Performing the procedure in the GI lab has a 2.5 reduction in total cost compared to the operating room.

Endolumenal Vacuum Therapy and Fistulojejunostomy in the Management of Sleeve Gastrectomy Staple Line Leaks.

Laparoscopic sleeve gastrectomy (LSG) is the most common bariatric surgery performed for morbid obesity. Leaks of the vertical staple line can occur in up to 7% of cases and are difficult to manage. Endolumenal vacuum (EVAC) therapy and fistulojejunostomy (FJ) have separate documented uses to heal these complicated leaks. We aim to show the benefit of using EVAC with FJ in the treatment of LSG staple line leaks. The patient presented with an LSG chronic leak. EVAC therapy was initiated but failed to close the fistula after 101 days. EVAC therapy was abandoned, and FJ was performed to resolve the leak. Postoperatively, no leak was encountered requiring any additional procedures. Based on our findings, we conclude that EVAC therapy facilitates in resolving leaks that restore gastrointestinal continuity and maintain source control. It promotes healing and causes reperfusion of ischemic tissue and fistula cavity debridement.

Use of a novel technique to manage gastrointestinal leaks with endoluminal negative pressure: a single institution experience.

BACKGROUND: Perforations and anastomotic leaks of the gastrointestinal tract are severe complications, which carry high morbidity and mortality and management of these is a multi-disciplinary challenge. The use of endoluminal vacuum (EVAC) therapy has recently proven to be a useful technique to manage these complications. We report our institution's experience with this novel technique in the chest, abdomen, and pelvis. METHODS: This is a retrospective review of an IRB approved registry of all EVAC therapy patients from July 2013 to December 2016. A total of 55 patients were examined and 49 patients were eligible for inclusion: 15 esophageal, 21 gastric, 3 small bowel, and 10 colorectal defects. The primary endpoint was closure rate of the GI tract defect with EVAC therapy. RESULTS: Fifteen (100%) esophageal defects closed with EVAC therapy. Mean duration of therapy was 27 days consisting of an average of 6 endosponge changes every 4.8 days. Eighteen (86%) gastric defects closed with EVAC therapy. Mean duration of therapy was 38 days with a mean of 9 endosponge changes every 5.3 days. Three (100%) small bowel defects closed with EVAC therapy. Mean duration of therapy was 13.7 days with a mean of 2.7 endosponge changes every 4.4 days. Six (60%) colorectal defects closed with EVAC therapy. Mean duration of therapy was 23.2 days, consisting of a mean of 6 endosponge changes every 4.0 days. There were two deaths, which were not directly related to EVAC therapy and occurred outside the measured 30-day mortality. CONCLUSION: Our experience demonstrates that EVAC therapy is feasible and effective for the management of gastrointestinal perforations/leaks throughout the GI tract and can be considered as a safe alternative to surgical intervention in select cases.

A study of the clinical utility of a 20-minute secretin-stimulated endoscopic pancreas function test and performance according to clinical variables.

BACKGROUND AND AIMS: Direct pancreas juice testing of bicarbonate, lipase, or trypsin after stimulation by secretin or cholecystokinin is used to determine exocrine function, a surrogate for diagnosing chronic pancreatitis (CP). Endoscopic pancreas function tests (ePFTs), where a peak bicarbonate concentration (PBC) ≥80 mEq/L in pancreas juice is considered normal, are now used more frequently. In this ePFT, aspirates start 35 minutes after secretin administration because pancreas output peaks 30 minutes after secretagogue administration. The performance of ePFT in a cohort of patients with a presumptive diagnosis of CP referred to a pancreas clinic for consideration of an intervention including total pancreatectomy and islet autotransplantation was studied, compared with EUS, ERCP, histology, and consensus diagnosis. The effect of sedation, narcotic use, aspirate volume, body mass index, age, and proton pump inhibitors (PPIs) on test performance is reported. METHODS: After a test dose, synthetic human secretin was administered intravenously, and 30 minutes later sedation was achieved with midazolam and fentanyl or propofol. A gastroscope was advanced to the major papilla where 4 continuous aspiration samples were performed at 5-minute intervals in sealed bottles. PBC ≥80 mEq/L was normal. RESULTS: Eighty-one patients had ePFTs from August 2010 through October 2015. Twenty-seven patients (33%) were diagnosed with CP. Eighteen of the 27 patients with CP and 1 of the 54 patients without CP had an abnormal ePFT, producing a sensitivity of 66% (95% CI, 46.0-83.5), specificity 98% (95% CI, 90.1-99.9), positive predictive value 94.7% (95% CI, 74-99.9), and negative predictive value 85.5% (95% CI, 74.2-93.1). ERCP and PBC concordance was generally poor, but none of the patients without CP had major EUS changes, and only 3 patients with a PBC <80 mEq/L had a normal EUS. The PBC was affected by narcotics and PPI use. CONCLUSION: A 20-minute ePFT after secretin administration had a marginal sensitivity for diagnosis of CP. The diagnosis of CP should not rely on a single study and certainly not a PFT. The duodenal aspirate volume did not correlate with the PBC, which contrasts with current secretin-enhanced MRCP knowledge; therefore, further studies on this subject are warranted. Neither type of sedation, BMI, nor age affected test performance. Narcotics and PPIs may affect the PBC, so borderline results should be interpreted with caution in these groups.

Management of gastric leaks after sleeve gastrectomy with endoluminal vacuum (E-Vac) therapy.

BACKGROUND: Sleeve gastrectomy has become a popular weight loss procedure, but it is associated with staple line leak resulting in high morbidity and mortality. Current management options range from endoscopic techniques (predominantly stent placement) to surgical intervention. OBJECTIVE: The purpose of this study was to recognize endoluminal vacuum (E-Vac) therapy as a viable option for use in anastomotic leaks of sleeve gastrectomies. SETTING: This study took place at Baylor University Medical Center at Dallas, Texas. METHODS: Retrospective and prospectively gathered registries for use of E-Vac therapy were queried to identify 35 patients. Using upper gastrointestinal series (UGI) and esophagogastroduodenoscopy, 9 of these patients were identified with a staple line leak from laparoscopic sleeve gastrectomy (LSG). E-Vac therapy was used to resolve the leak. RESULTS: Nine patients were treated with E-Vac therapy. Eight of 9 patients were admitted from outside hospitals with a mean of 61 days (5-233) after LSG. During treatment, an average of 10.3 procedures per patient was done to place and exchange the Endo-SPONGE. All 9 patients had resolution of leaks confirmed by upper gastrointestinal series, after undergoing E-Vac therapy for an average of 50 days. Six of 9 patients had laparoscopic procedures before their admission. During admission, 5 of the 9 patients had self-expanding metal stents placed with failure of leak resolution. Discharge disposition included 2 patients sent to rehabilitation facilities, 1 death not attributable to E-Vac, and 6 patients went home. CONCLUSION: E-Vac therapy is a viable option for patients with staple line leak after LSG.

Effect of the Duration of Chronic Pancreatitis on Pancreas Islet Yield and Metabolic Outcome Following Islet Autotransplantation.

BACKGROUND: Total pancreatectomy (TP) with islet autotransplantation (IAT) is a highly selected treatment for severe pain associated with chronic pancreatitis (CP) after exhausting medical and endoscopic therapies. The effect of duration of CP on TP-IAT has not been clarified. METHODS: Retrospective review of a consecutive cohort undergoing TP-IAT was performed. Patients were classified according to islet dose of <2500 IEQ/kg, 2500 to 5000 IEQ/kg, and >5000 IEQ/kg. Islet yield and metabolic outcomes were compared to disease duration of CP. RESULTS: A total of 76 CP patients underwent TP-IAT. Longer disease duration was associated with lower islet yield transplanted (Spearman's correlation = -0.24; p = 0.04) for total cohort. Highest absolute value of the coefficient was found in patients with hereditary CP when study subjects were classified by the etiology of CP (correlation = -0.72; p = 0.02). Higher islet yields were significantly associated with better metabolic outcomes (7.6 ± 1.1 vs 6.6 ± 1.1% of HbA1c post-TPIAT in patients with <2500 and >5000 IEQ/kg transplanted, respectively; p = 0.04). CONCLUSIONS: The duration of CP could affect islet yield and metabolic outcomes. The time since the diagnosis of CP should be considered when selecting patients for islet autotransplantation.

Cationic poly(2-aminoethylmethacrylate) and poly(N-(2-aminoethylmethacrylamide) modified cellulose nanocrystals: synthesis, characterization, and cytotoxicity.

Cellulose nanocrystals (CNCs) continue to gain increasing attention in the materials community as sustainable nanoparticles with unique chemical and mechanical properties. Their nanoscale dimensions, biocompatibility, biodegradability, large surface area, and low toxicity make them promising materials for biomedical applications. Here, we disclose a facile synthesis of poly(2-aminoethylmethacrylate) (poly(AEM)) and poly(N-(2-aminoethylmethacrylamide) (poly(AEMA)) CNC brushes via the surface-initiated single-electron-transfer living radical polymerization technique. The resulting modified CNCs were characterized for their chemical and morphological features using a combination of analytical, spectroscopic, and microscopic techniques. Zeta potential measurements indicated a positive surface charge, and further proof of the cationic nature was confirmed by gold deposition as evidenced by electron microscopy. The cytotoxicity of these cationic modified CNCs was evaluated utilizing a 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay in two different cell lines, J774A1 (mouse monocyte cells) and MCF-7 (human breast adenocarcinoma cells). The results indicated that none of the cationic modified CNCs decreased cell viability at low concentrations, which could be suitable for biomedical applications.