Introduction

Endoscopic submucosal dissection (ESD) is one of the effective treatments for superficial non-ampullary duodenal epithelial tumors (SNADETs). To avoid postoperative perforation and bleeding, our hospital had introduced D-LECS with ESD for SNADETs. From 2021, D-LECS was divided into D-LECS with FTR, which is a full-thickness resection, and D-LECS with ESD, which is intended for post-ESD reinforcement (1). D-LECS with ESD is considered to be a therapeutic procedure that not only ensures safety but also contributes to the improvement of endoscopic skills.

Aims & Methods

The aim of this study is to evaluate the impact of D-LECS with ESD on the skill development of endoscopists. The subjects were 17 cases in which D-LECS was performed among 79cases diagnosed with SNADA by biopsy at our hospital between January 2000 and October 2023. 5 cases in which D-LECS with ESD was performed. The ESD assessment score was defined using a ladder chart based on muscle layer exposure, perforation, ESD time, and pathological examination results. The scoring for points each item is as follows. (Exposure of muscle layer none: 0, <3mm: 1pt, 3~10mm: 2pt, 10mm<: 3pt, Perforation of the muscle none: 0, <3mm: 1pt, 3~10mm: 5pt, 10mm<: 10pt, ESD time <60min.: 0pt, 60~120min.: 5pt, 120min.<: 10pt, Pathological examination result pR0: 0pt, cR0+pRX: 5pt, pR1:10pt) Images and videos were used in combination to evaluate the muscle layer.

Results

ESD assessment scores of cases undergoing D-LECS with ESD were presented. The state of exposure of the muscle layer had a median of 5 (1-7), a mean of 4.8, and a standard deviation (SD) of 2.3. The state of perforation of the muscle layer had a median of 0 (0-10), a mean of 2.6, and a SD of 4.3. The median ESD time was 170 minutes, the mean was 146 minutes (41-198). The state of pathological examination had a median of 0 (0-10), a mean of 2.0, and a SD of 4.5. The ESD assessment scores are presented as follows: (Exposure of muscle layer, Perforation of muscles layer, ESD, Pathological examination result). The results of each score are as shown on the right, Case1: (7, 0,10, 0), Case2: (5,10, 10, 0), Case3: (5, 0, 10, 0), Case4: (6, 3, 10, 10), Case5: (1, 0, 1, 0). Although the number of cases was small, the time required for ESD was shortened and the degree of perforation tended to improve with experience. 2 examples revealed some important points. Case 1: This case had many blood vessels, and the ST hood was needed because it is difficult to perform ESD. When the endoscope was extended, perforation occurred. Once the perforation was made, it was difficult to move the patient to other bed, so the muscle layer was sutured with OTSC, and a PGA sheet. Case 2: The endoscopic strategy and device were improved, and the lesion could be dissected within 1 hour. ESD was performed with Dual Knife J 1.5. Pulling the lesion with an S-O clip. The RDI function was used during hemostasis to avoid the burn effect on the muscle layer.

Conclusion

D-LECS with ESD will lead to improvements of duodenal ESD techniques. But to ensure safety, laparoscopic closure is preferable until reliable suturing via endoscope becomes possible.

References

(1) Souya Nunobe, Motonari Ri, Naoki Hiki et al: Safety and Feasibility of laparoscopic and endoscopic cooperative surgery for duodenal neoplasm: a retrospective multicenter study. Endoscopy 53: 1065-1068, 2021

Introduction

Intragastric balloon (IGB) is a minimally invasive intervention used for obese patients who do not achieve adequate weight loss with standard medical therapy (SMT), which includes lifestyle interventions with or without pharmacological treatment. It is also an option for individuals who do not meet the criteria for bariatric surgery or choose not to undergo it. Despite its growing use, there is little data on the short and long-term effectiveness of IGB compared to SMT in randomized controlled trials (RCTs).

Aims & Methods

This systematic review and meta-analysis aimed to compare the efficacy of IGB therapy for at least six months versus SMT in the treatment of obesity, assessing outcomes at 6, 9, and 12 months. A comprehensive literature search was conducted in the MEDLINE, EMBASE, and Cochrane Library databases. The primary outcome was the percentage of excess weight loss (%EWL), while secondary outcomes included absolute weight loss (AWL), percentage of total weight loss (%TWL), and body mass index reduction (BMIR). We calculated mean differences (MD) with 95% confidence intervals (CI) for continuous outcomes. Meta-regression was performed using baseline body mass index (BMI) as a covariate, and subgroup analyses were conducted based on IGB type, baseline BMI, and pharmacological therapy in the SMT group.

Results

A total of 15 RCTs, including 1,961 patients, were included. Compared to SMT, IGB therapy resulted in significantly greater %EWL at 6 months (MD 16.80%; 95% CI [9.22%; 24.38%]), 9 months (MD 14.36%; 95% CI [7.67%; 21.04%]), and 12 months (MD 13.10%; 95% CI [10.43%; 15.77%]). IGB was also superior in AWL, %TWL, and BMIR across all time points (Table 1). Subgroup analyses revealed that results remained consistent regardless of pharmacological therapy use in the SMT group (p=0.77). The Orbera balloon showed superior %TWL at 6 months (p<0.01) and AWL at 6 months (test for subgroup differences with p=0.01), while the Spatz3 balloon demonstrated better %TWL at 9 months (p<0.01). Studies with a baseline BMI >40 kg/m² had significantly greater %TWL at 6 months (p=0.04) and AWL at 6 months (p<0.01) than those with BMI ≤40 kg/m². Meta-regression analysis indicated that higher baseline BMI was associated with greater AWL and BMIR at 6 months.

Conclusion

IGB therapy was significantly more effective than SMT, even when pharmacological therapy was included, leading to superior weight loss outcomes at 6, 9, and 12 months.

Table 1. Summary of findings.

References

1- Abu Dayyeh, Barham K, et al. Lancet. 2021.

2- Chan, Daniel L., et al. Obesity Surgery. 2021.

3- Coffin, B, et al. Obes Surg. 2017.

4- Courcoulas, et al. Int Journal of Obesity. 2017.

5- Farina, Maria Grazia, et al. Obes Surg. 2012.

6- Fuller, et al. Obes Bio and Int Physiology. 2013.

7- Gómez, V, et al. Obesity. 2016.

8- Hollenbach, M, et al. Digestion. 2024.

9- Kashani, et al. SN Comp Clinical Med. 2022.

10- Konopko-Zubrzycka, et al. J Clin Endoc Metab. 2009.

11- Lee, YM, et al. Gastrointest Endosc. 2012.

12- Mohammed, et al. Trends Med Res. 2014.

13- Ponce, J, et al. Surg Obes Relat Dis. 2015.

14- Sullivan, S, et al. Surg Obes Relat Dis. 2018.

15- Vicente, M, et al. Surgical Endoscopy. 2020.

Introduction

Upper gastrointestinal bleeding (UGIB) poses a significant threat in patients presenting to the emergency department, particularly in those with associated hemodynamic instability. Despite major advancements in medical and endoscopic therapeutic options, mortality rates have not shown a substantial decline over the years. This study aimed to assess clinical practice patterns in order to gain a clearer understanding of the pre-endoscopic assessment for patients with acute UGIB.

Aims & Methods

This study was an international online survey based on a prospective two-phase data collection approach, conducted between April 2023 and November 2023. The survey targeted practicing physicians actively involved in managing patients with UGIB. Data collection and management were performed through Research Electronic Data Capture (REDCap), an electronic data collection tool. The survey comprised four key domains: demographics and clinical practice, definitions of hemodynamic instability, pre-endoscopic assessment, and optimal timing of endoscopy, encompassing a total of 33 questions. The primary analysis provided a descriptive assessment of responses reported as proportions. Secondary analyses explored differences in responses based on years of clinical experience, practice setting, and the estimated annual number of UGIB cases encountered

Results

A total of 533 clinicians from 50 countries completed our survey. Among respondents, 54.6% work in university-based hospitals, and 67.7% reported managing over 100 UGIB patients annually. Regarding clinical experience, 55.7% have less than 10 years, with 44.3% with over 10 years of experience. Only 47.1% of respondents reported that their hospitals implement a triage system for UGIB patients. Additionally, 39.6% indicated that they do not use any risk stratification scores at the time of patient presentation. For initial fluid resuscitation, 0.9% saline (40.9%) and balanced crystalloid fluids (39.5%) were almost equally preferred. The rate of fluid resuscitation was reported to depend on the patient’s hemodynamic status by 40.2% of respondents. Most respondents indicated that hemodynamically unstable patients are primarily managed in the emergency department or intensive care unit. A total of 34.3% of respondents indicated that they do not routinely use prokinetics prior to endoscopy in UGIB patients, while 27.6% reported not commonly using them even in cases involving severe bleeding or known gastric emptying disorders. Proton pump inhibitors are administered prior to upper GI endoscopy in all cases by 70.4% of respondents, while vasoconstricting agents are used by 61% in cases of suspected variceal bleeding.

Conclusion

Our survey found considerable variability among respondents regarding the pre-endoscopic management of patients presenting with upper gastrointestinal hemorrhage. The overall adherence to international guidelines was low, which can potentially result in a significant negative impact on patient outcomes.

Introduction

Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, is efficacious in inducing clinical response at Week(W) 12 and maintaining clinical remission through W52 in patients with moderately-to-severely active Crohn’s disease (CD) as shown in the phase 3 treat-through trial VIVID-1 (NCT03926130).¹ Here, we present analysis of maintenance outcomes through W52 for Patient-Reported Outcome (PRO) clinical responders and nonresponders at W12.

Aims & Methods

The analysis set includes patients randomized to mirikizumab at baseline, who did or did not achieve PRO clinical response at W12 after intravenous (IV) induction treatment (900 mg mirikizumab IV every 4 weeks [Q4W]) before entering subcutaneous (SC) maintenance treatment (300 mg mirikizumab SC Q4W). Descriptive statistics are used to summarize the data, applying nonresponder imputation for missing binary endpoints. As a treat-through study, no rerandomization was applied.

Results

From a total of 551 patients who entered SC maintenance treatment, baseline characteristics of age, duration of CD, and baseline Crohn’s Disease Activity Index (CDAI) were similar between W12 PRO responders (n=402, 73.0%) and W12 PRO nonresponders (n=149, 27.0%). PRO responders at W12 had a higher objective inflammatory burden at baseline (faecal calprotectin, c-reactive protein, and Simple Endoscopic Score-CD), whereas concomitant or prior medication usage was similar between the groups. For W12 PRO responders, SC mirikizumab treatment from W12 to W52 resulted in an increase in CDAI clinical remission from 52.2% to 65.4%, PRO clinical remission from 53.2% to 65.4%, and endoscopic response from 35.1% to 54.7%, respectively (Table 1). Among W12 PRO nonresponders, PRO response was achieved by 39.6% at W16, 45.6% at W20, 44.3% at W24, and 56.4% at W52 with continued mirikizumab SC treatment, while CDAI clinical remission and PRO clinical remission were achieved by 33.6% and 31.5% at W52, respectively. Endoscopic response increased from 30.2% at W12 to 40.3% at W52 among W12 PRO nonresponders (Table 1).

Conclusion

Subcutaneous mirikizumab maintenance treatment over 40 weeks leads to incremental and sustained improvements in rates of clinical and endoscopic response regardless of PRO clinical response status after induction. A substantial proportion of clinical nonresponders at W12 improved early during maintenance treatment suggesting continued treatment with mirikizumab can be beneficial and lead to long-term response.

References

1. Ferrante, Marc et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024;404(10470):2423-2436. doi:10.1016/S0140-6736(24)01762-8

Introduction

Recent research from the Netherlands, the United States, and Korea suggests that individuals who receive a positive result on the fecal immunochemical test (FIT) may be at a higher risk of developing gastroesophageal cancer (GEC) within the following 36 months. However, the associations reported in these studies may be biased due to differences in age and sex between the FIT-positive and FIT-negative groups and other confounding factors.

Aims & Methods

We aimed to evaluate the association between FIT results and the risk of GEC in a matched cohort by age and sex. Additionally, we assessed the cost-effectiveness of a one-time Esophago-Gastro-Duodenoscopy (EGD) for individuals with positive FIT results.. We created a matched cohort of individuals aged 50 to 75 who underwent FIT testing at Clalit Health in Israel between June 2016 and June 2019. For each FIT-positive individual, we matched three FIT-negative individuals based on age, sex, and H. pylori status. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were utilized to evaluate the association between a positive FIT result and the risk of GEC within 36 months. We calculated the incremental cost-effectiveness ratio (ICER) for a one-time EGD at $400 in individuals who tested positive for FIT. Screening is considered cost-effective if the ICER is below $50,000.

Results

The primary cohort included 483,710 individuals, while the matched cohort comprised 151,500 individuals (47.6% female, median age 62.5 years). During the follow-up period, 202 cases of GEC occurred: 0.2% (64/38,575) among FIT-positive individuals and 0.1% (138/112,925) among FIT-negative individuals, adjusted HR 1.39 (95% CI 1.03-1.87). Age, male sex, H. pylori exposure, country of birth, proton-pump inhibitor usage, smoking status, and anemia were all significantly associated with an increased risk of gastric cancer. A one-time EGD has been determined to be a cost-effective option in a range of ages and rates of localized disease at the time of EGD.

Conclusion

This matched cohort study suggests that individuals with a positive FIT may have an increased risk of GEC, which occurs at an overall rate of 0.2% within 36 months. A one-time EGD priced at $400 can be cost-effective in many scenarios.

Disclosure

NONE