Citations

Objective: An endoscopically placed duodenal-jejunal bypass liner (DJBL) may provide a safe adjunctive therapy for those with poorly controlled type 2 diabetes mellitus (T2DM) and obesity. Background: Although some endoscopic therapies have been shown to improve glycemic indices secondary to weight loss, small bowel interventions may have direct metabolic effects. A meta-analysis of observational studies demonstrated reduction in HbA1c by 1.3% at 1 year after DJBL in patients with T2DM and obesity. Methods: This was a multicenter, double-blind, randomized, sham-controlled trial comparing DJBL to sham procedure with medical management and lifestyle modification. Primary endpoints included mean difference in changes in HbA1c at 12 months between arms, and device-related serious adverse events (SAEs). Secondary endpoints included percent total weight loss (%TWL) and subjects achieving HbA1c≤7% and TWL≥5% at 12 months. Results: Three hundred twenty subjects were randomized to DJBL (n=212) and sham (n=108). Baseline HbA1c and BMI were 8.79±0.92% and 38.45±5.75 kg/m 2 . On modified intent-to-treat analysis, change in HbA1c at 12 months was −1.10±1.45% and −0.28±1.54% for DJBL and sham groups, respectively ( P =0.0004). Rate of device-related SAEs was 9.4% including intolerance (3.7%), hemorrhage (2.8%), and hepatic abscess (2.3% stopping study early). At 12 months, DJBL group experienced greater weight loss compared with sham (7.7±9.6% TWL and 2.1±5.4% TWL, respectively; P <0.0001), with significantly more patients achieving HbA1c ≤ 7% (28.3% vs. 9.4%; P <0.0003) and TWL ≥ 5% (60.4% vs. 21.3%; P <0.0001). Conclusions: DJBL met primary glycemic control efficacy and primary safety endpoints, while providing clinically significant weight loss, and comorbidity improvement.

Abstract eSource – particularly EHR-to-EDC – is an emerging paradigm in clinical research that enables automated transfer of electronic health record (EHR) data into electronic data capture (EDC) systems, with the potential to reduce site burden, improve data quality and accelerate oncology clinical trial workflows. However, widespread implementation remains limited due to technical, regulatory and operational barriers. To address these challenges, the European Institute for Innovation through Health Data (i~HD) launched the eSource Scale-Up Task Force in 2024. This multi-stakeholder initiative brings together leading oncology centres and pharmaceutical sponsors to establish a consensus-driven roadmap for eSource adoption. Central to this effort are three foundational resources: readiness criteria for early adopters, a performance indicator framework for monitoring success and an operational playbook to guide implementation. This article provides a structured overview of the Task Force’s objectives, collaborative model and outputs, with specific attention to its focus on interoperability, regulatory alignment and real-world validation. While initially developed for oncology, the Task Force’s framework is applicable across therapeutic areas characterized by data-intensive workflows.

Abstract Introduction Pathogenic mutations in POLE/POLD1 lead to decreased fidelity of DNA replication, resulting in a high tumor mutational burden (TMB-H), defined as TMB ≥ 10 mut/Mb, independent of deficient mismatch repair (dMMR) and microsatellite instability high (MSI-H) status. Methods De-identified records of patients with colorectal cancer (CRC) profiled with the Tempus xT assay (DNA-seq of 595-648 genes at 500×) were identified from the Tempus Database. Results Among 9136 CRC samples profiled, the frequency of POLE/POLD1 genomic alterations was 2.4% (n = 217). Copy number loss was the most common genomic alteration (64%, n = 138) of POLE/POLD1, followed by copy number amplifications (18%, n = 40) and short variant mutations (18%, n = 39). The POLE/POLD1 mutated group presented with a higher frequency of TMB-H phenotype relative to wild type (WT; 22% vs. 9%, P &lt; .001), with a median TMB of 127 mut/Mb in the TMB-H POLE/POLD1 subset. The TMB showed a dramatic contrast between POLE/POLD1 short variant mutations as compared to the group with copy number alterations, with a TMB of 159 mut/Mb vs 15 mut/Mb, respectively. Thus, the short variant mutations represented the so-called ultra-hypermutated phenotype. The POLE/POLD1 mutated group, as compared to WT, exhibited a higher rate of coexisting mutations, including APC, ALK, ATM, BRCA2, and RET mutations. Conclusion Patients with POLE/POLD1 mutations exhibited significant differences across immunological markers (ie, TMB, MMR, and MSI-H) and molecular co-alterations. Those with short variant mutations represented 18% of the POLE/POLD1 cohort and 0.4% of the total cohort examined. This group of patients had a median TMB of 159 mut/Mb (range 34-488), representing the ultra-hypermutated phenotype. This group of patients is important to identify given the potential for exceptional response to immune checkpoint inhibitors.

AbstractThis joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0–29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Abstract Background and study aims A novel intragastric trocar placed using a percutaneous endoscopic gastrostomy technique enables the use of laparoscopic tools and procedures, including tissue stapling, cutting, suturing, and retraction. The aim of this porcine study was to determine long-term success of crossing full-thickness sutures in closure of the tract upon trocar withdrawal. Methods 10 trocars were placed in 5 animals. Each animal underwent a standardized tissue resection using a 5-mm stapler under gastroscopic guidance, and two full-thickness, absorbable, crossing sutures were used to close the trocar tracts. The animals were monitored for 35 days and then euthanized for necropsy. Results All five animals survived without sign of infection or distress. Nine of the 10 trocar sites healed completely without any adverse findings. A single site developed a gastrocutaneous fistula. On necropsy, there was no evidence of intra-abdominal infection or abscess. Conclusions Full-thickness crossing sutures appeared to be effective in long-term closure of an intragastric trocar tract. Given the ease of placement and success of this simple closure method, this device may prove clinically useful to the endoscopist performing complex procedures in the endoscopy suite.

Background Despite initial successful weight loss, some patients may experience weight regain following Roux-en-Y gastric bypass (RYGB). Objective To assess the impact of weight regain on bariatric patients’ quality of life (QoL). Methods This was a prospective cross-sectional study. Fifty-six consecutive RYGB patients were recruited and divided into weight-regain and weight-stable cohorts. QoL was assessed using the Bariatric Quality of Life (BQL) questionnaire. The BQL Index scores of the weight-regain and weight-stable groups were compared using Student’s t -test. Additionally, the BQL Index score of the weight-regain group was compared with that of historical prebariatric patients. Predictors of BQL were assessed using univariate and multivariate linear regression analyses. Results Of 56 RYGB patients, 41 (73%) had weight regain. On average, patients had body mass index (BMI) of 37 ±7.5 kg/m 2 and gained 34 ±26% of maximal weight initially lost. Weight-regain patients had lower BQL Index scores than weight-stable patients (44.8±6 vs 53±7, p<0.001). Patients with weight regain had similar BQL Index scores as the prebariatric patients despite lower BMI (BMI of 39.7±6.8 vs 47.2±7.6, p<0.05; BQL Index of 44.8±6 vs 41.6±10.4, p=0.144, respectively). Years from RYGB, BMI and amount of weight regain were associated with BQL Index on a univariate analysis (β=−0.55,−0.52, −0.7; p<0.0001). Only weight regain was a significant predictor of BQL on a multivariate analysis (β =−0.56; p=0.001). Conclusion Weight regain had a negative impact on bariatric patients’ QoL. Patients who regained at least 15% of maximal weight lost appeared to have as low QoL as those who had not undergone bariatric surgery despite a lower BMI.