Introduction

Endoscopic submucosal dissection (ESD) is a common treatment for early-stage gastrointestinal cancers, but managing delayed bleeding from post-ESD ulcers can be challenging. With more patients taking antithrombotic drugs, reliable bleeding prevention methods are crucial. This study presents the Dumpling technique, a new solution for preventing delayed bleeding from these ulcers.

Aims & Methods

Dumpling technique: The technique involves using a double-lumen catheter to inject fibrin glue into the pocket created after suturing an artificial ulcer post-ESD. This technique not only covers the ulcer but also provides a tamponade effect through compression. The fibrin glue is encased by the sutured mucosa, giving it the appearance of a dumpling. An important point of this technique is the use of a double-lumen catheter for fibrin glue injection. Fibrin glue consists of a fibrinogen solution and thrombin solution. Single-lumen catheters cannot be used because the two solutions begin to form a gel in just a few seconds when mixed. One advantage of this technique is that it combines existing products, so no new product development time is required.
An artificial ulcer was created in the resected bovine rectum by ESD flow, fixed to a jig, and a defect of 2.7 mm in diameter was created using an Aorta/Vein Punch. Pig blood that had lost coagulability was then injected to create a hemorrhage model. First, pressure resistance was measured after clip sutures only. Next, the same ulcer was used as is, the blood was washed out, fibrin glue was injected, and pressure resistance was measured again and compared between the two groups (Clip suture group vs Dumpling technique group). In addition, to confirm the feasibility of the technique, the Dumpling technique was performed endoscopically on porcine explanted stomach and bovine explanted rectum, and the excised specimens were evaluated.

Results

The mean ± SD pressure resistance in the bleeding model was 40.2 ± 14.0 mmHg in the clip suture group and 134.5 ± 36.8 mmHg in the Dumpling technique group (N = 5). Feasibility checks confirmed that suture spacing could be performed endoscopically without problems by setting the suture spacing to allow catheter tip insertion. The resection specimen was confirmed to be sufficiently filled with fibrin glue in the pocket.

Conclusion

This study suggests that the Dumpling technique improves the bleeding prevention effect of ulcer closure. Although various methods of ulcer suturing are still being developed, the injection of fibrin glue itself is expected to be adoptable by many clinicians because it does not require high skill if the tip of the catheter can be inserted through the gap between the sutures. We plan to confirm the feasibility of the Dumpling method in an in vivo study using pigs, followed by a clinical trial to confirm the effectiveness of the Dumpling technique.

Disclosure

Mr. Takegawa is employees of KM Biologics Co., Ltd. and the fibrin glue (BOLHEAL®) used in this article is manufactured by KM Biologics Co., Ltd.

Introduction

Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) is the most prevalent hepatic disorder worldwide. While histology remains the gold standard, a shift is evident in emerging studies favoring Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) over biopsy as a reliable alternative for steatosis assessment. Similarly, Controlled Attenuation Parameter (CAP) enables the noninvasive assessment of liver steatosis.

Aims & Methods

To assess the accuracy of CAP for MASLD diagnosis as defined by MRI-PDFF. We performed a cross-sectional, diagnostic accuracy study with prospectively collected data. We included consecutive adult participants with type 2 diabetes (T2D) and increased body mass index (BMI ≥25 kg/m²). We used receiver operating characteristic (ROC) curve analyses to assess the accuracy of CAP for diagnosing MASLD (MRI-PDFF ≥5%), and hepatic fat content (HFC) ≥10%. For each ROC analysis, we calculated the area under the ROC (AUROC) alongside 95% Confidence Intervals (CIs), and cutoffs for ruling out (sensitivity >90%) and ruling in (specificity >90%) the target condition. For each cutoff, we calculated the negative (NPV) and positive predictive values (PPV), as well as negative (LRn) and positive (LRp) likelihood ratios with their 95% CIs.

Results

We included 113 participants (58.4% males, mean age 59.6 years). Most participants (95.6%) had a BMI ≥30 kg/m². CAP measurements were performed with the M probe in 36.3% of the participants, and the remaining (63.7%) were scanned with the XL probe. MRI-PDFF values ranged from 1.9% to 37.8% covering the whole spectrum of steatosis. The prevalence of MASLD was 72.6%. The AUROC of CAP for MASLD diagnosis was 0.82 (0.74 to 0.89). The threshold for ruling out MASLD was 249 dB/m yielding a sensitivity (Sens) of 90.2% (81.7 to 95.7), specificity (Sp) 35.5% (19.2 to 54.6), LRp 1.40 (1.07 to 1.83), LRn 0.27 (0.12 to 0.62), PPV 78.7% (73.8 to 82.9) and NPV 57.9% (37.9 to 75.6). Similarly, the threshold for ruling in MASLD was 328 dB/m yielding a Sens, Sp, LRp, LRn, PPV and NPV of 47.6% (36.4 to 58.9), 90.3% (74.2 to 98.0), 4.91 (1.64 to 14.75) and 0.58 (0.46 to 0.74), 92.9% (81.2 to 97.5) and 39.4% (34.0 to 45.2), respectively. The AUROC of CAP for detecting HFC ≥10% was 0.81 (0.73 to 0.88). CAP thresholds for ruling out/in HFC ≥10% were 271 dB/m and 345 dB/m respectively. CAP measurements with IQR < 30 dB/ did not improve the accuracy of CAP for MASLD diagnosis

Conclusion

CAP has acceptable diagnostic accuracy in identifying patients with MRI-PDFF defined MASLD. Thresholds below 249 and 271 dB/m can be used to exclude MALSD and HFC ≥10% with adequate sensitivity. Similarly, CAP values over 328 and 345 dB/m can rule in MASLD and HFC ≥10% respectively.

Disclosure

This study was supported by the Hellenic Association for the Study and Education of Diabetes Mellitus

Introduction

Control of intraoperative bleeding is vital in endoscopic submucosal dissection (ESD) for gastric neoplasms. We developed an ESD method specialized for hemostasis (Spray-ESD) focusing on the Spray coagulation mode (VIO3; ERBE) with high voltage, easy spark control, and improved incision performance.

Aims & Methods

This study aimed to determine the efficacy of Spray-ESD for gastric neoplasms compared to conventional ESD (C-ESD).
An open-label, randomized, controlled trial was conducted from June 2021 to February 2022 at five centers in Japan, and patients with gastric neoplasms meeting the absolute indication for ESD were included in the study. (The clinical registration number is UMIN000034353) Patients were randomized 1:1 to Spray-ESD or C-ESD, and the outcomes of both groups were compared. ESD was performed with an electrosurgical knife: ProKnife. Hemostatic forceps: Hemostat-Y was used for soft coagulation when bleeding was difficult to control. The primary endpoint was the completion rate of ESD using the knife alone without hemostatic forceps. Secondary endpoints were the number and duration of hemostatic forceps use, ESD procedure time, radical cure, and safety.

Results

We analyzed 130 registered cases (Spray-ESD: 65 cases, C-ESD: 65 cases). The completion rate of ESD using the knife alone was significantly higher in Spray-ESD (83.1% vs. 13.8%, P<0.001). The number and duration of hemostatic forceps use were significantly lower in Spray-ESD (median: 1 vs. 3.5 times, P<0.001; 2.0 min vs. 5.5 min, P<0.001). ESD procedure time was not significantly different between the two groups (48.0 min vs. 56.0 min, P=0.11). Both groups had equally high resection rates (complete en bloc resection rate: 100% vs. 95.4%, P=0.24; curative resection rate: 90.8% vs. 87.7%, P=0.78), with a low adverse events rate. (3.1% [posterior bleeding in 2 cases] vs. 6.2% [intraoperative perforation in 1 case, posterior bleeding in 3 cases], P=0.68).

Conclusion

Spray-ESD has been shown to significantly reduce major bleeding requiring hemostats while maintaining a high en bloc resection rate; mastery of the Spray coagulation mode allows for safe ESD with reduced bleeding risk.

Introduction

Increased intestinal permeability, or leaky gut, is a condition where the gut's epithelial barrier is compromised, allowing bacteria and toxins to enter the blood stream. In liver cirrhosis, this can exacerbate liver damage and accelerate disease progression by perpetuating inflammation and immune system activation. Accurate assessment of this dysfunction is critical to the management of cirrhotic patients, but traditional methods such as serum markers and indirect assays often lack specificity and sensitivity.
Confocal laser endomicroscopy (CLE) is an advanced imaging technique that provides real-time, high-resolution visualisation of the gastrointestinal tract at the cellular and subcellular levels. CLE is used to diagnose leaky gut by directly observing disruptions in the intestinal mucosa. It integrates a confocal microscope within an endoscope, enabling in vivo histology-like imaging during routine endoscopic examinations.

Aims & Methods

We aimed to use confocal laser microendoscopy (CLE) in the diagnosis of intestinal barrier dysfunction by direct observation of the intestinal mucosa, in patients with liver cirrhosis. CLE (Cellvizio, Mauna Kea Technologies) was performed in the second part of the duodenum following intravenous administration of 2.5 – 5 mg of fluorescein in 58 patients with liver cirrhosis of various aetiologies. These patients were undergoing routine endoscopic surveillance or therapeutic intervention for oesophageal varices. The study cohort consisted of 39 men (61.9%) and 19 women (30.2%), with a mean age of 53.9 ± 14.0 years. We collected and analysed the most recent results of hepatic venous pressure gradient (HVPG), liver stiffness measurement (LSM), and fibrosis index for liver fibrosis (Fib-4). A Watson score of 1 indicates normal barrier function, while a Watson score of 2 indicates impaired barrier function. Data are given as mean± standard deviation, statistical analysis included Chi-square tests and Student’s t-tests, with a significance level set at p<0.05. NS=not significant.

Results

We observed a gradation of intestinal barrier dysfunction that correlated with the severity of liver cirrhosis. Specifically, of the 35 patients with Child-Pugh A cirrhosis, 18 (51.4%) had a Watson score of 2. In the group of 14 patients with Child-Pugh B cirrhosis, 9 (64.3%) had a Watson score of 2 and of the 9 patients with Child-Pugh C cirrhosis, 8 (88.9%) had a Watson score of 2, further underscoring the trend of increasing intestinal barrier dysfunction with increasing liver disease severity (p<0.05). In contrast, no significant differences in hepatic venous pressure gradient (HVPG) were observed between patients with Watson score 1 (16.8 ± 6.2 mmHg) and Watson score 2 (17.2 ± 6.2 mmHg, p NS). Similarly, liver stiffness measurements (LSM) showed no statistical difference between patients with Watson score 1 (39.0+/-23.7 kPa) and those with score 2 (40.2 ± 22.9 kPa) (p NS)=. Similarly, Fib-4 was 4.5 +/-3.1 in patients with Watson score 1 and 5.7+/-3.6 in patients with Watson 2 (p NS).

Conclusion

The findings suggest an association between the severity of liver cirrhosis and impaired intestinal barrier function as assessed by CLE. This impairment does not correlate with changes in haemodynamic parameters or liver fibrosis. The CLE promises to provide accurate and immediate diagnostic data and to improve our understanding of the pathophysiological changes in the gut associated with liver cirrhosis. Further research is needed to explore the mechanisms linking the severity of cirrhosis to intestinal barrier dysfunction and its clinical implications.

Disclosure

No conflict of interest to declare

Introduction

Steatotic liver disease (SLD) encompasses a spectrum of conditions, including metabolic dysfunction-associated SLD (MASLD), alcohol-related liver disease (ALD), and the overlapping category of MetALD. SLD affects more than a third of adults globally, but the majority remain undiagnosed, partially due to its lack of symptoms and limited awareness among patients and physicians. Adults undergoing screening colonoscopy, typically aged ≥50 years, represent a key population for targeted SLD detection, as they have a higher prevalence of cardiometabolic risk factors and is already engaged with preventive healthcare.

Aims & Methods

We examined 610 consecutive individuals aged ≥50 years with no known history of chronic liver disease who were referred for a colonoscopy for colorectal cancer screening. The protocol included sonographic assessment of liver steatosis and point shear wave elastography (pSWE) for liver fibrosis quantification, anthropometric measurements, biochemistry, medical history and alcohol intake evaluation. From the collected data, non-invasive fibrosis scores were calculated and used for aetiological and risk stratification.

Results

A total of 543 patients were included in the final analysis, after excluding patients with an invalid pSWE measurement (5.3%, n=29) and then excluding patients with incomplete results (n=38). The median age was 64 years (IQR 57-70) and 54.0% were male. The median BMI was 28.7 kg/m² (IQR 25.8–31.4) in males and 28.3 kg/m² (IQR 24.2-31.5) in females. SLD was identified in 63.4 % (n=344) of participants. Elevated liver stiffness (pSWE ≥ 1.30 m/s) was found in 26.9 % (n=146), and 4.8% (n=26) had values ≥1.70 m/s, suggestive of compensated advanced chronic liver disease. Among patients with pSWE ≥ 1.30 m/s, MASLD was the predominant aetiology (69.9%, n=102), followed by MetALD (15.8%, n=23), ALD (1.4%, n=2), cryptogenic (11.6%, n=17) and other etiologies (1.4%, n=2). Preselection using EASL-EASD-EASO criteria (i.e. presence of type 2 diabetes or central obesity plus ≥1 cardiometabolic risk factor and elevated liver enzymes) would have detected 365 at-risk individuals (67.2% of the cohort) of whom 55.9% (n=204) had a FIB-4 index ≥1.30. This approach would have identified only 30.4% (n=38) of all the patients with MASLD/MetALD with elevated liver stiffness (n=125).

Conclusion

Opportunistic screening for SLD in patients undergoing screening colonoscopy could be a useful strategy for detecting asymptomatic and potentially progressive liver disease. This approach identified a high prevalence of SLD (63.4%) and elevated liver stiffness (26.9%) in this population, primarily due to MASLD and MetALD. The integration of ultrasound and elastography added minimal burden to the existing workflow while enabling early risk stratification without the need for additional patient visits or referrals.

References

1 Tacke F, Horn P, Wong VWS, Ratziu V, Bugianesi E, Francque S, et al. EASL–EASD–EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). Journal of Hepatology [Internet]. 2024 Jun 7;81(3):492–542.
2 Lazarus JV, Miralles-Sanchez JE, Agirre-Garrido L, Brachowicz N, Nicolàs A, Armenta A, et al. A call to action to address the steatotic liver disease public health threat in Barcelona. The Lancet Regional Health - Europe [Internet]. 2025 Mar 22;52:101272.
3 Barr RG, Wilson SR, Rubens D, Garcia-Tsao G, Ferraioli G. Update to the Society of Radiologists in Ultrasound Liver Elastography Consensus Statement. Radiology [Internet]. 2020 Jun 9;296(2):263–74.

Introduction

Various endoscopic closure procedures including over-the-scope systems and endoscopic hand suturing have been tested in preventing delayed bleeding after endoscopic resection1). Conventional procedures are technically difficult with long procedure time1), which partially explains its limited application in clinical practice. The novel through-the-scope (TTS) helix and tack suture system has been reported with high success rates and acceptable procedure time using in vivo porcine models along with clinical experience2,3). However, past reports have not identified the proficiency rate of the TTS suture system.

Aims & Methods

The objective of this study is to determine the number of cases needed in achieving closure time of literature-based mean closure time. One beginner with less than 400 experiences of upper gastrointestinal endoscopy and one expert with clinical experience of over 500 endoscopic submucosal dissections participated in this study. Both endoscopists were familiarized with the functionality and troubleshooting of the novel TTS suture system via educational videos. Four in vivo porcine models were used to create 24 mucosal defects with diameter of 2-4 cm in the stomach. Each endoscopist were randomly allocated 12 mucosal defects to close with one set of TTS suture system per procedure. The TTS suture system engages four 5 mm helical tacks tethered to a suture thread into the defect margin and approximates the mucosal defect by applying suture tension with a cinch. The primary outcome was the number of procedures required to achieve closure procedure time below the literature-based mean closure time (7.7 minutes) by inverse curve fitting with nonlinear regression. The secondary outcomes were the success rate of complete closure and the incidence of adverse events. Complete closure was defined as over 90% closure of defect in endoscopy image assessed by two certified endoscopy technicians.

Results

Mean (±SD) size of the mucosal defects was 2.9 (±0.2) cm. Both endoscopists required six cases to achieve a closure time of less than 7.7 minutes. The median closure time was 8.2 (IQR: 5.6-10.1) minutes for the expert and 8.0 (IQR: 6.3-9.4) minutes for the beginner (P = 0.8624). The success rates of complete closure were 75.0% (9/12) for the expert and 83.3% (10/12) for the beginner. Neither endoscopist experienced any adverse events.

Conclusion

The novel TTS suture system requires a small number of cases for both expert and beginner to achieve proficiency in endoscopic closure.

References

1) Kobara H, et al. Dig Endosc. 2023;35(2):216-31.
2) Hernandez A, et al. Endosc Int Open. 2021;09:E572-7.
3) Farha J, et al. Endoscopy. Published online: 12 Jan 2023; doi:10.1055/a-1970-5528.