TSGE Research Grant UpdatesEffect of an Automated Clinical Pathway Utilizing Custom Risk Stratification on Rates of Overdue Follow Up and Outcomes in Patients with Inflammatory Bowel Disease David Fudman, MD This pragmatic randomized controlled trial compares a novel EMR-based tool to standard-of-care practice in improving clinical follow-up for patients with inflammatory bowel disease (IBD). The tool identifies patients overdue for follow-up based on dynamic risk status and time since last evaluation. Patients flagged as overdue are contacted to schedule follow-up appointments. Outcomes include the proportion of time spent overdue, clinical outcomes, and completion of objective measures of inflammation. The 15-month trial began in December 2025.
Comparison of the Performance of a Novel Bipolar RFA Knife to the Traditional Monopolar Knife in POEM (Per Oral Endoscopic Mytomy) Randomized Controlled Trial Randomized controlled trial comparing the clinical efficacy of a bipolar current knife versus monopolar current knife during esophageal peroral endoscopic myotomy: a multicenter noninferiority study (with video) Salmaan Jawaid, Mohan Ramchandani, Pradev Inavolu, Zaheer Nabi, Eduardo Albéniz Arbizu, Mai Khalaf, Michael Mercado, Zacharias Tsiamoulos, Fares Ayoub, Tara Keihanian, Haydee Cueto, Mohamed O Othman Affirmations Expand
Abstract Methods: A noninferiority RCT study evaluating BC versus MC knife during E-POEM at 3 centers. Primary outcome was technical success: ability to perform the entire procedure with the intended knife. Results: Technical (96% vs. 100%, P = .15) and clinical success (92.7% vs. 92.7%) was similar between the BC (n = 52) and MC knives (n = 52). Their tunneling speeds (0.65 vs. 0.85 cm/min, P = .24) were similar, but procedure times (62.9 vs. 53.2 minutes, P = .04, d = 0.41) were slightly shorter in the MC knife group. In addition, 77% of patients in the BC knife group completed the entire procedure with 1 instrument versus none in the MC knife group. Only 1 major adverse event occurred in the BC knife group (managed endoscopically) (1.9%). Conclusions: The 3-in-1 function of a novel bipolar radiofrequency knife can facilitate POEM with one device.
Assessment of Patients with Chronic Loose Stools Following Right-Sided Colectomy for Colon Cancer and the Association with Bile Acid Malabsorption (BAM) and Small Intestinal Bacterial Overgrowth (SIBO), Using a Novel Intestinal Fluid Sampling Device Background: Colorectal cancer survivors (CS) have increased significantly over the last decade. Around 10% report late gastrointestinal sequelae. Patients who have undergone sigmoid colectomy (SC) with colo-colonic or colorectal anastomosis suffer from obstructed defecation, while patients with right-sided colectomy (RC) and ileo-colonic anastomosis report frequent bowel movements. The underlying pathophysiology for this is unclear and presumably multifactorial. Aims: We plan to (1) assess symptoms of colonic dysfunction and impact on quality of life in patients with RC and SC and (2) examine the relationship of symptoms to gut microbial and bile acid profiles using a novel ingestible intestinal fluid sampling device (Capscan). Study design & Methods: CS (ages 20-85 years) presenting for routine colonoscopic surveillance will be categorized into Group one (RC, patients) and Group two (SC, patients). Patients with a history of Inflammatory bowel disease (IBD), long-term proton pump inhibitory therapy, recent (4 weeks) antibiotic exposure and symptoms of bowel obstruction will be excluded. Bowel symptoms will be assessed. Capscan will be provided to obtain samples from multiple regions of the intestinal tract. Microbiome patterns and bile acid profiles will be analyzed and compared among the two groups. Status: Total number of patients recruited: 9 Estimated time to complete the recruitment and enrollment: November 30, 2026
Discovering Novel Predictors of Therapy Response in Acute Severe Ulcerative Colitis This research project aims to apply a multi-omics approach to identify novel tissue- and blood-based biomarkers that predict response to intravenous corticosteroids and medical rescue therapy in patients with acute severe ulcerative colitis (ASUC). The project is progressing as planned. To date, a total of 51 patients with ASUC have been enrolled, and colon tissue and blood samples have been successfully collected. Colon tissue samples have been processed and submitted for single-cell RNA sequencing (scRNA-seq), with results anticipated in September 2026. Blood samples have undergone proteomic analysis, and data processing and interpretation are currently underway. We anticipate completing data analyses by October 2026. Preliminary findings generated from this work will support additional grant applications planned for submission in December 2026. Overall, the project remains on schedule, and we expect to complete all proposed aims within the anticipated timeline.
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