Single-incision needle-knife biopsy for the diagnosis of GI subepithelial tumors: a systematic review and meta-analysis.

BACKGROUND AND AIMS: A histologic diagnosis of GI subepithelial tumors (SETs) is important because of the malignant potential of these lesions. The current modalities of choice, including EUS-guided FNA and biopsy (EUS-FNA/FNB) have demonstrated suboptimal diagnostic success. Single-incision with needle-knife (SINK) biopsy has emerged as an alternative diagnostic approach to increase tissue acquisition and diagnostic success. The aim of this study was to perform a systematic review and meta-analysis to evaluate the technical success, diagnostic success, and adverse events of SINK biopsy. METHODS: We searched multiple databases including PubMed, EMBASE, CINAHL, Cochrane, Web of Science, and Google Scholar from inception to July 2022. The primary outcomes assessed were the technical success and diagnostic success of SINK in GI SETs. The secondary outcomes assessed were adverse events and whether immunohistochemical analysis could be successfully performed on tissue samples obtained via SINK. RESULTS: Seven studies with a total of 219 SINK biopsy procedures were included in this meta-analysis. The technical success rate was 98.1% (95% CI, 94.9%-99.3%; P = .000; I2 = .0%), and the diagnostic success rate was 87.9% (95% CI, 82.6%-91.7%; P = .000; I2 = .0%). The immunohistochemical success rate was 88.3% (95% CI, 78.7%-93.9%; P = .000; I2 = 3.5%). The rate of adverse events was 7.5% (95% CI, 4.3%-12.7%; P = .00; I2 = 7.2%), and bleeding was the most common adverse event. CONCLUSION: SINK biopsy is a safe diagnostic procedure with a high technical and diagnostic success in patients with GI SET. Further randomized controlled trials and direct comparison studies are needed to validate these findings.

A Systematic Review and Meta-Analysis: A Prior Appendectomy Does Not Increase the Risk of Severe Clostridioides difficile Infection or Recurrence.

BACKGROUND AND OBJECTIVES: There is conflicting evidence regarding the association between a prior appendectomy and severity of Clostridioides difficile infection. The aim of this study was to perform a systematic review and meta-analysis to evaluate this association. PATIENTS AND METHODS: Comprehensive review of multiple databases was performed up to May 2022. The primary outcome assessed was the rate of severe Clostridioides difficile infection in patients with a prior appendectomy compared to patients with an appendix. The secondary outcomes assessed were recurrence, mortality, and colectomy rates associated with Clostridioides difficile infection in patients with a prior appendectomy compared to patients with an appendix. RESULTS: Eight studies with 666 patients with a prior appendectomy and 3580 patients without an appendectomy were included. The odds ratio of severe Clostridioides difficile infection in patients who underwent prior appendectomy was 1.03 (95% CI 0.6-1.78, p = 0.92). The odds ratio of recurrence in patients who underwent prior appendectomy was 1.29 (95% CI 0.82-2.02, p = 0.28). The odds ratio of colectomy due to Clostridioides difficile infection in patients who underwent prior appendectomy was 2.16 (95% CI 1.27-3.67, p = 0.004). The odds ratio of mortality due to Clostridioides difficile infection in patients with a prior appendectomy was 0.92 (95% CI 0.62-1.37, p = 0.68). CONCLUSION: Patients with appendectomy are not at increased risk for developing severe Clostridioides difficile infection or recurrence. Further prospective studies are needed to establish these associations.

New Alternative? Self-Assembling Peptide in Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND: Gastrointestinal bleeding (GIB) is a common and potentially fatal condition with all-cause mortality ranging from 3 to 10%. Endoscopic therapy traditionally involves mechanical, thermal, and injection therapies. Recently, self-assembling peptide (SAP) has become increasingly available in the United States. When applied to an affected area, this gel forms an extracellular matrix-type structure allowing for hemostasis. This is the first systematic review and meta-analysis to assess the safety and efficacy of this modality in GIB. METHODS: We performed a comprehensive literature search of major databases from inception to Nov 2022. The primary outcomes assessed were the success of hemostasis, rebleeding rates, and adverse events. The secondary outcomes assessed were successful hemostasis with monotherapy with SAP and combined therapy, which may include mechanical, injection, and thermal therapies. Pooled estimates were calculated using random-effects models with a 95% confidence interval (CI). RESULTS: The analysis included 7 studies with 427 patients. 34% of the patients were on anticoagulation or antiplatelet agents. SAP application was technically successful in all patients. The calculated pooled rate of successful hemostasis was 93.1% (95% confidence interval (CI) 84.7-97.0, I2 = 73.6), and rebleeding rates were 8.9% (95% CI 5.3-14.4, I2 = 55.8). The pooled rates of hemostasis with SAP monotherapy and combined therapy were similar. No adverse events were noted related to SAP. CONCLUSION: SAP appears to be a safe and effective treatment modality for patients with GIB. This modality provides an added advantage of improved visualization over the novel spray-based modalities. Further, prospective, or randomized controlled trials are needed to validate our findings.

Early- and late-onset pancreatic adenocarcinoma: A population-based comparative study.

BACKGROUND: Pancreatic cancer is projected to become the second leading cause of cancer related death in the US. We aim to investigate the demographics, clinical outcomes and survival outcomes of patients diagnosed with early-onset (<40 years) and late-onset (>40 years) pancreatic adenocarcinoma (PAC). METHODS: Data on PAC between 1975 and 2016 were extracted from the Surveillance, Epidemiology, and End Results Registry. RESULTS: Within the study period, 136,100 patients were identified which included 1181 patients with early-onset PAC and 134,919 patients with late-onset PAC. Both cohorts tend to present with distant metastasis (70.3% vs 57.9%). Both groups also showed an exponential rise in incidence (early-onset 3.69% annual change vs late-onset 6.25% annual change). When stratified by anatomical location, there was a trend of increasing cancer in the head of the pancreas for patients <40 years (3.63% annual change). While late PAC showed increasing cancer in all anatomical locations, the largest increase was observed in the tail of the pancreas (8.62% annual change). Overall, there was a mild difference in survival for early- and late-onset PAC (7 months vs 6 months, respectively, log rank p = 0.004). Both age groups showed the worse prognosis when cancer occurred in the tail of the pancreas (6 months vs 4 months, respectively). On cox proportion analysis, patients with late-onset PAC had twice the risk of mortality compared to early-onset PAC (HR 2.06, CI: 1.788-2.370, P = 0.001). CONCLUSIONS: Our study showed that both early- and late-onset PAC are increasing and while prognosis remains poor. Tumor anatomy showed a growing incidence of early-onset PAC in the head of the pancreas while late-onset PAC showed a rising incidence in the body and tail of the pancreas.

Incidence Rates, Treatment, and Survival of Rectal Cancer Among Young Patients: A Nationwide Cohort Study.

BACKGROUND: The incidence of colorectal cancer is increasing among young adults in the United States. We aim to investigate the incidence rate, the effect of multimodal therapy, and survival outcomes of rectal cancer in patients under 45 years of age. PATIENTS AND METHODS: Data on young-onset (under 45 y) rectal cancer between 2000 and 2016 was extracted from the Surveillance, Epidemiology, and End Results Registry (SEER). RESULTS: A total of 10,375 patients with young-onset rectal cancer were identified where 54.7% were male. The median age at diagnosis was 40±5.7 years. The overall age-adjusted incidence of rectal cancer between 2000 and 2016 was 1.24 per 100,000 per year. Incidence increased with age, with the highest incidence occurring in the 40- to 44-year age group. Over the 16-year study period, rectal cancer increased by ∼2.29%. Most tumors on presentation were moderately differentiated (30.8%) while the most common stage at presentation was stage 4 (48.3%). One- and 5-year cause-specific survival for rectal cancer was 93% and 72%, respectively. According to Cox proportional hazard models, chemotherapy was associated with increased mortality in patients with localized cancer [hazard ratio (HR)=2.88, 95% confidence interval (CI): 2.04-4.08, P<0.001], did not significantly improve mortality outcomes in patients with regional cancer (HR=0.89, 95% CI: 0.70-1.04, P=0.116), but reduced mortality in patients with distant cancer (HR=0.62, 95% CI: 0.56-0.70, P<0.001), though this effect was largely seen in patients 35 years and older. Surgery was associated with improved survival across all cancer stages. CONCLUSIONS: The incidence of regional and distant rectal cancer is increasing in young patients. While patient age is an important prognostic indicator of survival, chemotherapy does not appear to improve survival in younger patients with localized and regional disease.

Influence of the Elipse Intragastric Balloon on Obesity and Metabolic Profile: A Systematic Review and Meta-Analysis.

BACKGROUND: Intragastric balloons (IGBs) have been used to bridge the obesity treatment gap with the benefits of being minimally invasive but still required endoscopy. The Elipse IGB is a swallowable balloon that is spontaneously excreted at ∼16 weeks. However, studies are limited by small sample sizes. The authors aim to assess clinically relevant endpoints, namely weight loss outcomes, metabolic profile, balloon tolerability, and adverse events. METHODS: A literature search was performed from several databases from inception to July 2020. The pooled means and proportions of our data were analyzed using a random effects model. RESULTS: Seven studies involving 2152 patients met our eligibility criteria and were included. The mean baseline body mass index ranged from 32.1 to 38.6. The pooled mean difference (MD) in body mass index was 0.88 [confidence interval (CI): 0.58-1.18, I2=98%]. Total body weight loss was 12% (CI: 10.1-14.3, I2=94%) and excess body weight loss was 49.1% (CI: 30.6-67.5, I2=97%). The MD in waist circumference was 0.89 (CI: 0.72-1.05, I2=53%). MD in triglyceride level was 0.66 (CI: 0.21-1.1, I2=96%). Pooled early deflation rate was 1.8% (CI: 0.6-5.1, I2=74%). Our study also showed that the Elipse balloon was associated with less adverse events when compared with other IGBs. CONCLUSIONS: This meta-analysis demonstrates that the Elipse intragastric balloon is a safe, effective, and tolerable device for weight loss and obesity with a minimal side effect profile.

The Efficacy and Safety of Hemospray for the Management of Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

GOALS/BACKGROUND: Hemospray is a new hemostatic powder recently approved for endoscopic hemostasis in gastrointestinal (GI) bleeding. Data are limited in terms of its clinical outcomes, and its role in the treatment algorithm of GI bleeds. We conducted a systematic review and meta-analysis to study the clinical performance of Hemospray in the management of GI bleeding. STUDY: We searched multiple databases from inception through March 2019 to identify studies that reported on the clinical outcomes of Hemospray in GI bleeding. The primary outcome was pooled rates of clinical success after the application of Hemospray in GI bleeding. The secondary outcomes were pooled rebleeding rates and adverse events after use of Hemospray. RESULTS: A total of 19 studies, 814 patients, of which 212 patients were treated with Hemospray as monotherapy, and 602 patients were treated with Hemospray with conventional hemostatic techniques. Overall pooled clinical success after the application of Hemospray was 92% [95% confidence interval (95% CI), 87%-96%; I2=70.4%]. Overall pooled early rebleeding rates after application of Hemospray was 20% (95% CI, 16%-26%; I2=54%). Overall pooled delayed rebleeding rates after the application of Hemospray was 23% (95% CI, 16%-31%; I2=34.9%). There was no statistical difference in clinical success (RR, 1.02; 95% CI, 0.96-1.08; P=0.34) and early rebleeding (RR, 0.89; 95% CI, 0.75-1.07; P=0.214) in studies that compared the use of Hemospray as monotherapy versus combination therapy with conventional therapy. CONCLUSIONS: Hemospray is highly effective in achieving immediate hemostasis in gastrointestinal bleeding. However, due to significantly high rebleeding rates, Hemospray is not suited for definitive long-term therapy.

Gender and racial disparities in colorectal cancer incidence and mortality: a national cancer registry study.

INTRODUCTION: The incidence of CRC is higher in minority racial and ethnic groups. However, studies assessing trends among sex and racial groups on the incidence and mortality of CRC are lacking. We aim to investigate disparities in CRC by reviewing a large national cancer registry. METHODS: This is a retrospective cross-sectional study of the Surveillance, Epidemiology, and End Results Registry (SEER) of individuals aged 45-79 years from 2000-2017. RESULTS: During the study period, the incidence of CRC decreased for both males and females, respectively (APC -2.14 vs -1.81). Among all racial groups, African American showed the least decline in incidence of CRC. African American females showed the highest risk for CRC (IRR 1.34; 95% CI 1.32-1.36, p< 0.001) compared to other females or males from different racial groups. Subgroup analysis using Kaplan-Meier estimations showed that African American females had the poorest 5-year survival rate (56%) compared to other female racial groups. Among males, American Indian/Alaska Natives had the poorest 5-year survival (54%) compared to male of other racial groups. CONCLUSION: Overall, the incidence of colorectal cancer is declining. However, the incidence of CRC remains highest in African Americans females who are also burden with poor survival rates.

Fecal Microbiota Transplantation (FMT) with Colonoscopy Is Superior to Enema and Nasogastric Tube While Comparable to Capsule for the Treatment of Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-Analysis.

BACKGROUND: Several routes of fecal microbiota transplantation (FMT) administration are available for treating recurrent Clostridioides difficile infections (CDI), the most recent of which are capsules. AIM: To assess the efficacy of colonoscopy, capsule, enema, and nasogastric tube (NGT) FMT for the treatment of recurrent CDI. METHODS: We reported clinical outcomes of colonoscopy, capsule, enema, and NGT FMT for the treatment of recurrent CDI according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. During January 2000 to January 2018, three databases were searched: PubMed, EMBASE, and CINAHL. Primary outcome was overall cure rate which was assessed using a random effects model; secondary outcomes included adverse effects as well as subgroup analyses comparing donor relationship, sample preparation, and study design. RESULTS: Twenty-six studies (1309 patients) were included in the study. FMT was administered using colonoscopy in 16 studies (483 patients), NGT in five studies (149 patients), enema in four studies (360 patients), and capsules in four studies (301 patients). The random effects of pooled FMT cure rates were colonoscopy 94.8% (CI 92.4-96.8%; I2 15.6%), capsule 92.1% (CI 88.6-95.0%; I2 7.1%), enema 87.2% (CI 83.4-90.5%; I2 0%), and NGT/NDT 78.1% (CI 71.6-84.1%; I2 0%). On subgroup analysis of colonoscopy FMT, sample preparation methods had comparable cure rates: fresh 94.9% compared to 94.5%. Similarly, cure rates were unaffected by donor relationship: mixed 94.5% compared to unrelated donor 95.7%. CONCLUSION: CDI cure rates with FMT performed with colonoscopy are superior to enema and NGT FMT, while those with FMT with colonoscopy and capsule are comparable.

Clostridioides difficile infection in US hospitals: a national inpatient sample study.

BACKGROUND: Hypervirulent strains of Clostridioides difficile have altered the landscape of hospital and community outbreaks. We aim to examine and compare spatiotemporal trends, incidence, hospital teaching status, mortality, and cost associated with hospital-acquired Clostridioides difficile infection (HCDI) and community-acquired Clostridioides difficile infection (CCDI). METHODS: Retrospective cohorts were studied using data from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) from 2006 to 2015. RESULTS: A total of 76,124 cases of HCDI and 190,641 cases of CCDI were identified within the study period. The incidence of HCDI decreased from 8555 in 2006 to 7191 in 2015. Mortality also decreased during the same period (5.9% in 2006 to 1.4% 2015, p < 0.0001). Conversely, CCDI cases increased from 13,823 in 2006 to 20,637 in 2015. CCDI mortality decreased during the same period (4.3% in 2006 to 1.9% 2015, p < 0.0001). Rural hospital centers experienced the sharpest decline in HCDI mortality compared to urban and urban teaching centers (3.8%, p < 0.0001 vs 2.8%, p < 0.0001 vs 2.1%, p < 0.0001). Multivariate logistic regression indicated that increasing age (p = 0.0001), increasing hospital length of stay (p = 0.0001), and Medicare insurance (p = 0.002) were significant predictors of mortality for CDI mortality. Geospatial mapping of CCDI and HCDI revealed that the Eastern and Southern US experienced the largest incidence of CDI over 10 years. CONCLUSION: The incidence of HCDI has decreased in the past decade while the incidence of CCDI hospitalization is sharply on the rise. While hospital length of stay and mortality has decreased over time, the cost of treating CDI remains high.

Awareness of Nonalcoholic Fatty Liver Disease Is Increasing but Remains Very Low in a Representative US Cohort.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) has become the most common form of chronic liver disease in the USA. Interestingly, most patients with NAFLD are unaware of having any liver disease (LD). We aimed to assess the awareness of suspected NAFLD and factors associated with being aware of LD. METHODS: Adult subjects with suspected NAFLD (BMI > 25) with elevated ALT in the absence of secondary causes of LD who participated in the continuous national health and nutrition examination survey (NHANES) during 2001-2016 were identified and analyzed. Trends of NAFLD awareness were then assessed in periods of 4 years each. Multivariable logistic regression analysis was performed to assess factors associated with LD awareness. RESULTS: A total of 7033 subjects were included in the final analysis (1731, 1757, 1711, and 1834 subjects for the periods of 2001-2004, 2005-2008, 2009-2012, and 2013-2016, respectively). Over the study duration, an increase in BMI, waist circumference, diabetes, and HbA1c; and a decrease in the number of smokers, platelets count, bilirubin, total cholesterol, and LDL level were noticed (p < 0.001). Awareness of having LD across study periods has increased over time from 1.5% in the 2001-2004 periods to 3.1% in the 2013-2016 periods. Multivariable logistic regression analysis showed that older age, ethnicity (non-black), having fewer drinks/week, metabolic syndrome, higher ALT, ALP, and GGT were associated with being aware of having LD. CONCLUSIONS: Awareness of having LD among subjects with suspected NAFLD has increased over the last two decades, but more than 95% of these patients are still unaware of having LD. Educational programs to increase awareness of LD and risk factors for NAFLD should be implemented on a large scale. CLINICAL TRIAL REGISTRATION NUMBER: Not required, as we used de-identified NHANES data.

Endoscopic ultrasound-guided portal pressure gradient measurement: a systematic review and meta-analysis.

Background: Endoscopic ultrasound-guided portal pressure gradient measurement (EUS-PPG) is a new modality where the portal pressure is measured by directly introducing a needle into the hepatic vein and portal vein. This is the first systematic review and meta-analysis to evaluate the efficacy and safety of EUS-PPG. Methods: A comprehensive literature search was performed to identify pertinent studies. The primary outcomes assessed were the technical and clinical success of EUS-PPG. Technical success was defined as successful introduction of the needle into the desired vessel, while clinical success was defined as the correlation of the stage of fibrosis on the liver biopsy to EUS-PPG, or concordance of HVPG and EUS-PPG. The secondary outcomes were pooled rates for total and individual adverse events related to EUS-PPG. Pooled estimates were calculated using random-effects models with a 95% confidence interval (CI). Results: Eight cohort studies with a total of 178 patients were included in our analysis. The calculated pooled rates of technical success and clinical success were 94.6% (95%CI 88.5-97.6%; P=<0.001; I2=0) and 85.4% (95%CI 51.5-97.0%; P=0.042; I2=70), respectively. The rate of total adverse events was 10.9% (95%CI 6.5-17.7%; P=<0.001; I2=4), and 93.7% of them were mild, as defined by the American Society for Gastrointestinal Endoscopy. Abdominal pain (11%) was the most common adverse event, followed by bleeding (3.6%). There were no cases of perforation or death reported in our study. Conclusions: EUS-PPG is a safe and effective modality for diagnosing portal hypertension. Further randomized controlled trials are needed to validate our findings.

Safety of endoscopic pancreatic necrosectomy compared with percutaneous and surgical necrosectomy: a nationwide inpatient study.

Background and study aims Pancreatic necrosis is an independent predictor of morbidity and mortality among patients with acute pancreatitis. We compared the safety and outcomes of three techniques including endoscopic necrosectomy, fluoroscopy-guided percutaneous necrosectomy by an interventional radiologist, and surgical necrosectomy. Patients and methods Using the Nationwide Readmissions Database, we identified hospitalized patients who underwent pancreatic necrosectomy from 2016 to 2019. They were identified using the International Classification of Diseases, 10th Revision, Procedure Coding System. Results: Of the 2,281 patients meeting the selection criteria, the method of pancreatic necrosectomy was as follows: endoscopy (n = 672), percutaneous (n = 1,338), and surgery (n = 271). Compared to surgery, the rate of mortality was lowest for endoscopy (hazard ratio (HR) 0.27; 95 % CI 0.08-0.90; P  = 0.033) followed by percutaneous (HR 0.44; 95 % CI, 0.20-0.98; P  = 0.045). Endoscopy was associated with less post-procedure bleeding compared to percutaneous and surgical necrosectomy ( P  < 0.001), as well as lower rates of post-procedure renal failure ( P  < 0.001) and respiratory failure ( P  = 0.002). Endoscopy was associated with average shorter lengths of stay and total hospital costs when compared with percutaneous and surgical approaches, respectively (20.1 vs 25.8 vs 38.3 days; P  < 0.001) and ($ 57K vs $ 76K vs $ 123K; P  < 0.001). Conclusions Endoscopic necrosectomy is associated with significantly lower risk of inpatient mortality, adverse events, length of stay, and cost when compared to percutaneous and surgical approaches.

Impact of utilization of hepatitis C positive organs in liver transplant: Analysis of united network for organ sharing database.

BACKGROUND: The utility of hepatitis C virus (HCV) organs has increased after the Food and Drug Administration approval of direct acting anti-viral (DAA) medications for the HCV treatment. The efficacy of DAA in treating HCV is nearly 100%. AIM: To analyze the United Network for Organ Sharing (UNOS) database to compare the survival rates between the hepatitis C positive donors and negative recipients and hepatitis C negative donors and recipients. METHODS: We analyzed the adult patients in UNOS database who underwent deceased donor liver transplant from January 2014 to December 2017. The primary endpoint was to compare the survival rates among the four groups with different hepatitis C donor and recipient status: (Group 1) Both donor and recipient negative for HCV (Group 2) Negative donor and positive recipient for HCV (Group 3) Positive donor and negative recipient for HCV (Group 4) Both positive donor and recipient for HCV. SAS 9.4 software was used for the data analysis. Kaplan Meier log rank test was used to analyze the estimated survival rates among the four groups. RESULTS: A total of 24512 patients were included: Group 1: 16436, Group 2: 6174, Group 3: 253 and Group 4: 1649. The 1-year (Group 1: 91.8%, Group 2: 92.12%, Group 3: 87%, Group 4: 92.8%), 2-year (Group 1: 88.4%, Group 2: 88.1%, Group 3: 84.3%, Group 4: 87.5%), 3-year (Group 1: 84.9%, Group 2: 84.3%, Group 3: 75.9%, Group 4: 83.2%) survival rates showed no statistical significance among the four groups. Kaplan Meier log rank test did not show any statistical significance difference in the estimated survival rates between Group 3 vs all the other groups. CONCLUSION: The survival rates in hepatitis C positive donors and negative recipients are similar as compared to both hepatitis C negative donors and recipients. This could be due to the use of DAA therapy with cure rates of nearly 100%. This study supports the use of hepatitis C positive organs in the selected group of recipients with and without HCV infection. Further long-term studies are needed to further validate these findings.

Medications and the risk of perforated appendicitis: an adverse event report system (FAERS) database analysis.

OBJECTIVE: Different classes of medication have been reported in the literature to be associated with an increased risk of gastrointestinal perforation. However, little is known about the risk of drug-induced perforated appendicitis. METHODS: We analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS), a large national database of reported adverse events associated with post-market FDA-approved medications from January 2011 to October 2021. Patients of any age group with appendiceal perforation were included. Duplicated reports and other anatomical areas of gastrointestinal tract perforation outside the appendix were excluded. RESULTS: During the study period, 474 event cases met inclusion criteria, of which 284 were females. Most reports of perforation occurred in patients 40-49 years (n = 110) and 50-59 years (n = 144). Cases of perforated appendicitis occurred in patients being treated for multiple sclerosis (31.5%) and rheumatoid arthritis (17.1%). Perforation occurred in patients receiving interferon beta 1a (23.6%), adalimumab (17.9%), etanercept (14.1%), natalizumab (12.2%), clozapine (10.1%), infliximab (9.9%), bevacizumab (7.2%), and calcium chloride (4.9%). Sixteen fatal outcomes were reported. CONCLUSION: Findings from the FAERS database highlight the risk of appendiceal perforation in the context of different classes of drugs. Larger pharmacovigilance studies are needed to confirm these observations.

A comparison of balloon- versus stent-based approach for dominant strictures in primary sclerosing cholangitis: a meta-analysis.

Background: Approximately 10-62% of patients with primary sclerosing cholangitis (PSC) will develop dominant strictures at some point during their disease. Because of the paucity of available data, optimal endoscopic therapeutic strategies remain unclear. We performed a systematic review and meta-analysis of endoscopic balloon dilation vs. balloon dilation plus stenting of dominant strictures in PSC. Methods: A comprehensive literature search from inception to November 2020 was performed. Primary outcomes were clinical and technical success. Secondary outcomes reported were adverse events (AE). Clinical success was defined in most studies as improvement in symptoms such as fever, abdominal pain, pruritus, fatigue and/or liver enzymes. The statistical analysis was done using comprehensive meta-analysis (CMA Version 3). Results: The technical success rates for balloon and balloon plus stent were 96.8% and 91.9%, respectively. The clinical success rates for balloon and balloon plus stent were 86.5% and 70.8%, respectively. The overall AE rates for balloon and balloon plus stent were 11.2% and 26.9%, respectively. Other AE rates in balloon and balloon plus stent were cholangitis (4.8% vs. 11.4%), bile duct perforation (1.3% vs. 1.6%), post-procedural pancreatitis (2.2% vs. 9.8%), and bleeding (1.5% vs. 1.2%), respectively. Low to considerable heterogeneity was noted in our meta-analysis. Conclusions: Balloon dilation appears to be superior in terms of clinical and technical successes, with overall lower rates of AE compared to balloon dilation plus stenting for the management of PSC dominant strictures. Further trials are needed to validate our findings.

Endoscopic cryotherapy: Indications, techniques, and outcomes involving the gastrointestinal tract.

Endoscopic cryotherapy is a technique utilized for the ablation of target tissue within the gastrointestinal tract. A cryotherapy system utilizes the endoscopic application of cryogen such as liquid nitrogen, carbon dioxide or liquid nitrous oxide. This leads to disruption of cell membranes, apoptosis, and thrombosis of local blood vessels within the target tissue. Several trials utilizing cryotherapy for Barrett's esophagus (BE) with variable dysplasia, gastric antral vascular ectasia (GAVE), esophageal carcinoma, radiation proctitis, and metastatic esophageal carcinomas have shown safety and efficacy. More recently, liquid nitrogen cryotherapy (cryodilation) was shown to be safe and effective for the treatment of a benign esophageal stricture which was refractory to dilations, steroid injections, and stenting. Moreover, liquid nitrogen cryotherapy is associated with less post procedure pain as compared to radiofrequency ablation in BE with comparable ablation rates. In patients with GAVE, cryotherapy was found to be less tedious as compared to argon plasma coagulation. Adverse events from cryotherapy most commonly include chest pain, esophageal strictures, and bleeding. Gastric perforations did occur as well, but less often. In summary, endoscopic cryotherapy is a promising and growing field, which was first demonstrated in BE, but the use now spans for several other disease processes. Larger randomized controlled trials are needed before its role can be established for these different diseases.

Safety and efficacy of EUS-guided ablation of pancreatic lesions with ethanol versus ethanol with paclitaxel: A systematic review and meta-analysis.

Background and Objectives: EUS-guided ethanol ablation has emerged as an alternative method for pancreatic lesions. Recently, paclitaxel was added to ethanol to assess ablative effects in pancreatic lesions. We performed a systematic review and meta-analysis on EUS-guided ethanol ablation (EUS E) versus EUS-guided ethanol with paclitaxel (EUS EP) ablation for the management of pancreatic lesions. Methods: Comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, Google Scholar, and Web of Science databases (from inception to May 2020). The primary outcome evaluated complete ablation of the lesions radiologically and the secondary outcome evaluated adverse events (AEs). Results: Fifteen studies on 524 patients were included in our analysis. The pooled complete ablation rate was 58.89% (95% confidence interval (CI) = 38.72-77.80, I2 = 91.76%) and 55.99% (95% CI = 44.66-67.05, I2 = 0) in the EUS E and EUS EP groups (P = 0.796), respectively. The pooled AE rates were 13.92% (95% CI = 4.71-26.01, I2 = 83.43%) and 31.62% (95% CI = 3.36-68.95, I2 = 87.9%) in the EUS E and EUS EP groups (P = 0.299), respectively. The most common AE was abdominal pain at 7.27% (95% CI = 1.97-14.6, I2 = 68.2%) and 12.44% (95% CI = 0.00-39.24, I2 = 81.1%) in the EUS E and EUS EP groups (P = 0.583), respectively. Correlation coefficient (r) was ‒0.719 (P = 0.008) between complete ablation and lesion size. Conclusion: Complete ablation rates were comparable among both groups. AE rates were higher in the EUS EP group. Further randomized controlled trials are needed to validate our findings.

Efficacy of EUS-guided needle-based confocal laser endomicroscopy in the diagnosis of pancreatic lesions: A systematic review and meta-analysis.

Background and Objectives: Needle-based confocal laser endomicroscopy (nCLE) is a procedure in which an AQ-Flex nCLE mini-probe is passed through an EUS-FNA needle into a pancreatic lesion to enable subsurface in vivo tissue analysis. In this study, we conducted a systematic review and meta-analysis of nCLE for the diagnosis of pancreatic lesions. Materials and Methods: We conducted a comprehensive search of several databases and conference proceedings, including PubMed, EMBASE, Google-Scholar, MEDLINE, SCOPUS, and Web of Science databases (earliest inception to March 2020). The primary outcomes assessed the pooled rate of diagnostic accuracy for nCLE and the secondary outcomes assessed the pooled rate of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and adverse events (AE) of nCLE to diagnose premalignant/malignant pancreatic lesions. Results: Eleven studies on 443 patients were included in our analysis. The pooled rate of diagnostic accuracy of EUS nCLE was 83% (95 confidence interval [CI] = 79-87; I 2 = 0). The pooled rate of sensitivity, specificity, PPV and NPV of EUS nCLE was 85.29% (95% CI = 76.9-93.68; I 2 = 85%), 90.49% (95% CI = 82.24-98.74; I 2 = 64%), 94.15% (95% CI = 88.55-99.76; I 2 = 68%), and 73.44% (95% CI = 60.16-86.72; I 2 = 93%), respectively. The total AE rate was 5.41% (±5.92) with postprocedure pancreatitis being the most common AE at 2.28% (±3.73). Conclusion: In summary, this study highlights the rate of diagnostic accuracy, sensitivity, specificity, and PPV for distinguishing premalignant/malignant lesions. Pancreatic lesions need to be further defined with more validation studies to characterize CLE diagnosis criteria and to evaluate its use as an adjunct to EUS-FNA.