Device malfunctions with use of EUS-guided fine-needle biopsy devices: Analysis of the MAUDE database.

Background: The safety of endoscopic ultrasound-guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods: The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results: There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]).The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion: The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.

Representation and reporting of diverse groups in randomised controlled trials of pharmacological agents in inflammatory bowel disease: a systematic review.

Inflammatory bowel disease (IBD) is now recognised as a global disease, with incidence rapidly increasing in newly industrialised countries in South America, Asia, and Africa. Trials in IBD, therefore, should adequately represent diverse groups with respect to gender, age, place of residence, race, and ethnicity to ensure the global applicability and generalisability of their findings. In this systematic review, we searched PubMed and Embase for randomised controlled trials (RCTs) published in English from Jan 1, 1995, to Jan 13, 2023, evaluating the efficacy of any pharmacological intervention in patients with IBD. Of 7543 records yielded in the search, we included 617 records reporting data from 627 RCTs and 108 986 participants. The results show a paucity of adequate representation of diverse groups in these RCTs. This finding was true for various groups, including racially and ethnically diverse populations, older (aged >65 years) and younger (aged <18 years) populations, those who identify outside of the gender binary, and people from South America and Africa. Also, some regions had an apparent scarcity of funding sources for trials. Pharmaceutical companies and clinical trial organisations should aim to ensure adequate representation of such under-represented groups in future IBD trials.

Evidence-based approach to diagnosis and management of abdominal tuberculosis.

Abdominal tuberculosis is an ancient problem with modern nuances in diagnosis and management. The two major forms are tuberculous peritonitis and gastrointestinal tuberculosis (GITB), while the less frequent forms are esophageal, gastroduodenal, pancreatic, hepatic, gallbladder and biliary tuberculosis. The clinicians need to discriminate the disease from the close mimics: peritoneal carcinomatosis closely mimics peritoneal tuberculosis, while Crohn's disease closely mimics intestinal tuberculosis. Imaging modalities (ultrasound, computed tomography, magnetic resonance imaging and occasionally positron emission tomography) guide the line of evaluation. Research in diagnostics (imaging and endoscopy) has helped in the better acquisition of tissue for histological and microbiological tests. Although point-of-care polymerase chain reaction-based tests (e.g. Xpert Mtb/Rif) may provide a quick diagnosis, these have low sensitivity. In such situations, ancillary investigations such as ascitic adenosine deaminase and histological clues (granulomas, caseating necrosis, ulcers lined by histiocytes) may provide some specificity to the diagnosis. A diagnostic trial of antitubercular therapy (ATT) may be considered if all diagnostic armamentaria fail to clinch the diagnosis, especially in TB-endemic regions. Objective evaluation with clear endpoints of response is mandatory in such situations. Early mucosal response (healing of ulcers at two months) and resolution of ascites are objective criteria for early response assessment and should be sought at two months. Biomarkers, especially fecal calprotectin for intestinal tuberculosis, have also shown promise. For most forms of abdominal tuberculosis, six months of ATT is sufficient. Sequelae of GITB may require endoscopic balloon dilatation for intestinal strictures or surgical intervention for recurrent intestinal obstruction, perforation or massive bleeding.