Reporting Quality of Endoscopic Colorectal Cancer Screening Randomized Controlled Trials: Adherence to Recommendations and Interventions.

Background and Aims: In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) steering group published recommendations to standardize reporting quality in randomized controlled trials (RCTs). We aim to assess adherence to SPIRIT reporting guidelines in RCTs on endoscopic colorectal cancer (CRC) screening and participants' adherence to trial protocols. Methods: We searched databases for RCTs evaluating flexible sigmoidoscopy or colonoscopy for CRC screening published in English language through September 2023. Each eligible study was evaluated using the 8 core SPIRIT statement areas, totaling 51 points. Each item received 1 point if it met the criteria and 0 points if it did not. Adherence to SPIRIT items was calculated, and participant adherence to RCT protocols was assessed as the proportion of participants screened compared to those invited. Results: Five RCTs, including 4 on flexible sigmoidoscopy and 1 on colonoscopy, were analyzed. Adherence to SPIRIT guidance ranged from 82.4% to 92.2%. The most missed recommendation was item 2b (trial registrations), scored 0 across all studies. Additionally, item 32 (informed consent materials) scored 20%, and items 17a & b (blinding) scored 40% each. In total, 587,572 participants were randomized across the 5 RCTs. Of these, 37% (200,610) underwent CRC screening, with 69.8% (139,983/200,610) adhering to the protocol. The Nordic-European Initiative on Colorectal Cancer (NordICC) trial, employing a unique invitation method, had a lower adherence rate of 42%. Excluding this trial would raise the adherence rate to 74.3% (128,050/172,390). Conclusion: The published CRC screening trials have acceptable adherence to the SPIRIT reporting guidelines. However, reporting appended consent form materials and disclosing all WHO trial registration data can be improved.

Adenomas and Sessile Serrated Lesions in 45- to 49-Year-Old Individuals Undergoing Colonoscopy: A Systematic Review and Meta-Analysis.

INTRODUCTION: Colorectal cancer (CRC) screening is now recommended at the age of 45 years in the United States. However, information regarding the adenomas detection rate (ADR) and sessile serrated lesions (SSLs) in 45- to 49-year-old individuals is limited. In addition, the impact of lowering the screening age to 45 years on the ADR and the detection rate of SSLs is not well elucidated. This systematic review and meta-analysis aims to report the overall ADR and SSL detection rate in 45- to 49-year-old individuals undergoing colonoscopy. METHODS: We searched MEDLINE, EMBASE, SCOPUS, Web of Science, ClinicalTrials.gov , and the Cochrane database from inception through October 2022 to identify studies reporting on ADR and SSL detection rates in 45- to 49-year-old individuals undergoing colonoscopies for all indications. This approach acknowledges the possibility of including individuals undergoing diagnostic colonoscopies or those with increased risk factors for CRC. We also conducted a separate analysis examining ADR in average-risk individuals undergoing screening colonoscopy. The pooled rates with their corresponding 95% confidence intervals (CIs) were generated using the fixed-effects model. I2 was used to adjudicate heterogeneity. RESULTS: Sixteen studies met the inclusion criteria. All studies were retrospective except one; 3 had data from national/local registries. There were 41,709 adenomas detected across 150,436 colonoscopies. The pooled overall ADR was 23.1% (95% CI 19.7%-27.0%, I2 = 98.6%). The pooled ADR in individuals with average risk of CRC from 7 studies was 28.2% (95% CI 24.6%-32.0%, I2 = 96.5%). The pooled overall SSL detection rate from 6 studies was 6.3% (95% CI 3.8%-10.5%, I2 = 97%). The included studies were heterogeneous because of differences in the inclusion and exclusion criteria and patient population. DISCUSSION: In 45- to 49-year-old individuals undergoing a colonoscopy for any indication, the ADR and SSL detection rates were 23.1% and 6.3%, respectively. We conclude that these outcomes in 45- to 49-year-olds are comparable with individuals aged 50-54 years.

Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

BACKGROUND: Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. METHODS: We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. RESULTS: Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). CONCLUSION: Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Efficacy and Safety of Cold Snare Endoscopic Mucosal Resection (CS-EMR) for Nonampullary Duodenal Polyps: Systematic Review and Meta-Analysis.

INTRODUCTION: There is an increasing interest in cold snare endoscopic mucosal resection (CS-EMR), and studies have shown its safety and efficacy for colonic polyps. This meta-analysis aims to assess the safety and efficacy of CS-EMR for the removal of duodenal adenomas. METHODS: We conducted a comprehensive literature search of several databases, from inception through February 2023, for studies that addressed outcomes of CS-EMR for nonampullary duodenal adenomas. We used the random-effects model for the statistical analysis. The weighted pooled rates were used to summarize the technical success, polyp recurrence, bleeding, and perforation events. Cochran Q test and I2 statistics adjudicated heterogeneity. RESULTS: Six studies were included in the analysis. In all, 178 duodenal polyps were resected using CS-EMR. The pooled rates were 95.8% (95% CI 89.1-98.5%, I2=21.5%) for technical success and 21.2% (95% CI 8.5-43.6%, I2=78%) for polyp recurrence. With regards to CS-EMR safety, the pooled rates were 4.2% (95% CI 1.6-10.5%, I2=12%) for immediate bleeding, 3.4% (95% CI 1.5-7.6%, I2=0%) for delayed bleeding, 2.8% (95% CI 1.1-6.7%, I2=0%) for perforation, and 2% (95% CL 0.5-7.5%, I2=0%) for post-polypectomy syndrome. Rates were not significantly different for large adenomas. Three studies reported data on CS-EMR and conventional EMR. Compared with conventional EMR, CS-EMR had lower odds of delayed bleeding, OR 0.11 (CI 0.02-0.62, P value 0.012, I2=0%). CONCLUSION: Our findings suggest that CS-EMR is a safe and effective strategy for the resection of nonampullary duodenal adenomas, with an acceptable recurrence rate. Data from larger randomized controlled studies are needed to validate our findings.

High prevalence of chronic viral hepatitis B and C in Minnesota Somalis contributes to rising hepatocellular carcinoma incidence.

BACKGROUND: Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are known risk factors for liver disease, cirrhosis and hepatocellular carcinoma (HCC). There is substantial global variation in HBV and HCV prevalence resulting in variations in cirrhosis and HCC. We previously reported high prevalence of HBV and HCV infections in Somali immigrants seen at an academic medical center in Minnesota. AIM: To determine the prevalence of chronic viral hepatitis in Somali immigrants in Minnesota through a community-based screening program. METHODS: We conducted a prospective community-based participatory research study in the Somali community in Minnesota in partnership with community advisory boards, community clinics and local mosques between November 2010 and December 2015 (data was analyzed in 2020). Serum was tested for hepatitis B surface antigen, hepatitis B core antibody, hepatitis B surface antibody and anti-HCV antibody. RESULTS: Of 779 participants, 15.4% tested positive for chronic HBV infection, 50.2% for prior exposure to HBV and 7.6% for chronic HCV infection. Calculated age-adjusted frequencies in males and females for chronic HBV were 12.5% and 11.6%; for prior exposure to HBV were 44.8% and 41.3%; and for chronic HCV were 6.7% and 5.7%, respectively. Seven participants developed incident HCC during follow up. CONCLUSION: Chronic HBV and HCV are major risk factors for liver disease and HCC among Somali immigrants, with prevalence of both infections substantially higher than in the general United States population. Community-based screening is essential for identifying and providing health education and linkage to care for diagnosed patients.

Endoscopic Ultrasound Guided Fine-Needle Aspiration for Solid Lesions in Chronic Pancreatitis: A Systematic Review and Meta-Analysis.

BACKGROUND: Patients with chronic pancreatitis (CP) are at a higher risk of developing pancreatic adenocarcinoma compared the general population with an estimated 5% risk of developing pancreatic cancer in 20 years. Endoscopic ultrasound fine needle aspiration (EUS-FNA) of solid pancreatic lesions (SPL) has an excellent sensitivity (85-90%) and specificity (98-100%) for diagnosing pancreatic malignancy. However, data on the performance characteristics of EUS-FNA in CP are mixed. AIMS: In this systematic review and meta-analysis, we aim to examine data from published studies on the diagnostic performance of EUS-FNA in detecting pancreatic malignancy in CP. METHODS: We conducted a comprehensive search of MEDLINE, Cochrane, EMBASE, Scopus databases for studies published in English language that reported performance characteristics of EUS-FNA for SPL up to November 2020. Two reviewers independently conducted screening, full text review and data extraction according to the PRISMA guidelines. Quality of included studies was assessed using the risk of bias in non-randomized studies of interventions (ROBINS-I) tool. The parameters of interest were sensitivity, specificity, negative, and positive likelihood ratios. Cochran Q test and I statistics were used to determine the between-study heterogeneity. Funnel plots were used to describe publication bias. RESULTS: A total of 6753 studies were identified on initial search. Studies that reported EUS-FNA of cystic pancreas lesions were excluded. Eight studies met the inclusion criteria. Seven studies were retrospective, and one was prospective. A total of 593 patients with CP underwent EUS-FNA for SPL. The pooled sensitivity of EUS-FNA was 65% (95% CI 52.6-75.6%, I2 = 44%), specificity was 96.8% (75-99.7%, I2 = 89%), negative likelihood ratio (NLR) 41.4 (11.1-149.6, I2 = 70%), positive likelihood ratio (PLR) 24.1 (2.8-208, I2 = 90%). The pooled data from seven studies that compared 901 non-CP vs. 127 CP showed that the sensitivity of EUS-FNA in diagnosing pancreatic malignancy was 91.5 vs. 65.3% [OR (95% CI) 5.5 (2.9-10.2), I2: 31.8%]. The specificity pooled from six studies [333 non-CP vs. 357 CP] was 95.9% vs. 82.4%, [OR (95% CI) 1.3 (0.2-9.8), I2 = 73%]. The risk of bias was serious in one study, low in four studies and moderate in three studies. CONCLUSION: This pooled meta-analysis shows a low sensitivity of EUS-FNA in diagnosing malignancy in CP patients with SPL in comparison to patients without CP. Modalities such as EUS-fine needle biopsy have high sensitivity and specificity for diagnosing pancreatic cancer and should be considered in patients with CP and suspected pancreatic malignancy.

Outcomes of Clostridioides difficile Infection in Patients With Liver Cirrhosis: A Nationwide Study.

BACKGROUND: Clostridioides difficile infection (CDI) is a major health problem that has been on the rise for the last couple of decades. It has significant mortality and morbidity in hospitalized patients. We looked at the outcomes of CDI in patients with liver cirrhosis compared to those without liver cirrhosis. METHODS: We conducted a retrospective study from a large inpatient database. The National Inpatient Sample (NIS) was queried for CDI admissions between January 2012 and September 2015. Patients admitted with CDI were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. The outcomes included overall mortality, length of hospitalization, and healthcare expenditure related to hospitalization. RESULTS: Out of all patients, 53,765 (3.97%) had concurrent CDI and liver cirrhosis. Diabetes mellitus, alcohol abuse, and acquired immunodeficiency were observed more in patients with liver cirrhosis. Overall mortality (adjusted odds ratio (aOR) 1.65, 95% confidence interval (CI) 1.53 - 1.77, P < 0.001), cost of hospitalization and length of hospital stay (11.0 vs. 10.4 days, P < 0.001) were significantly higher in patients with cirrhosis. CONCLUSIONS: Patients with CDI and liver cirrhosis have significantly higher mortality, prolonged hospitalization and healthcare expenditure. Further studies are recommended to look at reversible risk factors for CDI in patients with liver cirrhosis to guide quality measures that would ultimately improve outcomes.

The outcomes of Clostridioides difficile infection in patients with diverticular disease: a nationwide analysis.

Background: Clostridioides difficile infection (CDI) is one of the most common healthcare-associated infections. It contributes to significant morbidity and mortality among hospitalized patients in the United States. Prior studies suggest worse outcomes of CDI in patients with diverticulitis and increased risk for recurrent CDI. We conducted this study to evaluate the outcomes of CDI in patients with diverticular disease from a nationwide data sample (2012-2015).Methods: The National Inpatient Sample (NIS) database between January 2012 and September 2015 was queried for CDI admissions using the International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] codes 008.45, 562.11, 562.10, 562.12, and 562.13 for diagnoses of CDI and diverticular disease.Results: The study included 1,327,595 patients who were admitted between 2012 and 2105 for CDI. Out of all of the patients, 84,170 (6.34%) had a concurrent diagnosis of diverticular disease. After adjusting for confounding variables, the in-hospital mortality was lower [odd ratio (OR): 0.48, 95% CI: 0.44-0.52, p < .001] for patients with diverticular disease. The length of stay (LOS) was longer [10.5 versus 9.3 days, p < .001] and mean cost of hospitalization was significantly higher in patients without a history of diverticular disease.Discussion: In a nationwide population study, admissions with CDI, patients with a concurrent diagnosis of diverticular disease had lower in-hospital mortality. The observed results are different from prior studies and might be attributed to a higher burden of normal flora in those patients and increased use of antibiotic stewardship program across many hospitals nationwide.

Successful Treatment of a Case of Ectopic Jejunal Varices with Portal Venous Stenting.

BACKGROUND Management of patients with ectopic variceal bleeding can be challenging and requires a multidisciplinary approach. Ectopic bleeding from jejunal varices at the anastomotic site of choledochojejunostomy is rare and difficult to treat. CASE REPORT We report a case of ectopic jejunal variceal bleeding secondary to portal vein stenosis at the anastomotic site of a prior choledochojejunostomy for pancreatic cancer. The patient was successfully treated with portal vein metallic stent placement that remained patent for 7 months. CONCLUSIONS The management of ectopic of variceal bleeding remains difficult and controversial. Portal vein stenting has been reported as a successful method of treatment that is minimally invasive especially in patients who had prior major surgeries.

A Case of Cerebral Venous Sinus Thrombosis Presenting During Relapse of Ulcerative Colitis.

BACKGROUND Extra-intestinal manifestations of inflammatory bowel disease (IBD) include thromboembolic events that can present as deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis. Cerebral venous sinus thrombosis is a rare complication of IBD that can be associated with high morbidity and mortality. This report is of a case of cerebral venous sinus thrombosis presenting in a young man during a relapse of ulcerative colitis (UC). CASE REPORT A 27-year-old man presented with seizures and focal neurological deficit during a relapse of chronic UC. He was found to have left cerebral venous sinus thrombosis complicated by left frontotemporal infarction that was treated with anticoagulation therapy. CONCLUSIONS Thromboembolic events are well documented extra-intestinal manifestation of IBD. Cerebral venous sinus thrombosis is a rare but serious complication that can be fatal. The correct diagnosis and timely management require a high degree of suspicion in patients with IBD who present with a new-onset headache, focal neurological symptoms, seizure, or altered mental status.

'Acute leukemia in congenital methehemoglobinemia - an enigma to explore'.

Congenital methemoglobinemia is a rare disease, resulting in increased oxygen affinity and impaired oxygen delivery to the tissues. While there have been studies that have linked acquired methemoglobinemia in almost 79% of leukemia patients, to the best of our knowledge, this is the first case of leukemia development in a patient with congenital methemoglobinemia. Chronic deprivation of oxygen to metabolically active bone marrow can theoretically lead to hematopoietic disorders. It would be interesting to further investigate if presence of congenital methemoglobinemia is a risk factor for developing acute leukemia.

A fatal case of diffuse alveolar hemorrhage as the initial presentation of systemic lupus erythematosus: A case report and literature review.

Diffuse alveolar hemorrhage (DAH) is a rare fatal pulmonary complication of systemic lupus erythematosus (SLE). The clinical syndrome is characterized by hemoptysis, acute fall in hematocrit, hypoxemic respiratory failure, and diffuses pulmonary infiltrates. We describe a case of 23-year-old female who presented with Ludwig's angina that was complicated by diffuse alveolar hemorrhage as the initial presentation of undiagnosed systemic lupus erythematosus. A high index of suspicion is need for prompt diagnosis and treatment in order to avoid the high mortality associated with such cases.

A Fatal Case of Non-Uremic Calciphylaxis: A Case Report and Literature Review.

BACKGROUND Calciphylaxis is a rare cutaneous disease, also known as calcific uremic arteriolopathy, that occurs most frequently in patients with advanced chronic kidney disease and on long-term hemodialysis. CASE REPORT We describe the case of a 61-year-old female patient with worsening chronic kidney disease not on dialysis therapy, who presented with severe progressive calciphylaxis on both lower limbs. CONCLUSIONS Calcific uremic arteriolopathy is a rare fatal condition that requires prompt diagnosis and treatment. It is classically described in patients with end-stage kidney disease on long-term renal replacement therapy but can present in patients with an earlier stage of kidney disease. Non-uremic calciphylaxis should be suspected in patients with earlier stages of kidney disease, especially in those with other concurrent risk factors or co-morbid conditions, to avoid the high risk of morbidity and mortality associated with such cases.

Recurrent Unilateral Transudative Pleural Effusion Due to Low Flow, Low Gradient Severe Aortic Stenosis.

BACKGROUND In symptomatic severe aortic stenosis (AS), the majority of patients have high gradient AS. However, some patients have an AS gradient less than 40 with a valve area under 1.0 cm². For patients with a low gradient, severe AS is difficult to detect and requires a high index of suspicion. Transcatheter aortic valve replacement (TAVR) is currently recommended for patients with moderate to high risk AS according to the Society of Thoracic Surgery (STS) risk score. CASE REPORT Here we present the case of an 86-year-old female with recurrent pleural effusion over the course of 2-year; she had multiple thoracentesis procedures and was being considered for a pleurodesis. Later the patient was found to have severe AS; an echocardiogram showed an aortic valve (AV) area of 0.67 cm², AV mean gradient of 34 mmHg, and ejection fraction of 75%. The patient underwent a diagnostic cardiac catheterization and was treated with TAVR. CONCLUSIONS The diagnosis was made after exclusion of all other causes of unilateral pleural effusion and was confirmed by improvement of effusion following the TAVR procedure.

Coronary Artery-Left Ventricular Fistula and Takotsubo Cardiomyopathy - An Association or an Incidental Finding? A Case Report.

BACKGROUND A coronary artery-left ventricular fistula is an anomalous communication between the coronary arteries and the cardiac chambers and is a rare congenital coronary anomaly that is often small and asymptomatic. Takotsubo cardiomyopathy, on the other hand, is a syndrome characterized by transient regional systolic dysfunction of the left ventricle, mimicking myocardial infarction, but in the absence of angiographic evidence of obstructive coronary artery disease or acute plaque rupture. We present the case of an elderly woman who presented with Takotsubo cardiomyopathy and who was incidentally discovered to have an associated coronary artery-left ventricular fistula. CASE REPORT We report the case of a 68-years-old woman with a family history of premature cardiac diseases who presented with ischemic chest pain and elevated troponin levels. Her EKG and troponins were suggestive of non-ST-elevation myocardial infarction (NSTEMI), for which she was initially treated medically and later underwent coronary angiography. Unexpectedly, the angiography revealed patent coronary arteries, and we discovered evidence of coronary artery to left ventricular fistula in the addition to angiographic evidence of Takotsubo cardiomyopathy. A working diagnosis of Takotsubo was made, for which she was treated medically with resulting improvement of her symptoms and later in the imaging findings. CONCLUSIONS This described case illustrates a rare association between coronary artery fistulas and Takotsubo cardiomyopathy. It is unclear if this association has played a role in the pathogenesis or perhaps is just an incidental finding. More similar cases are needed to expand the clinical presentation of both conditions and add to the literature.