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VESSEL PRE-SEALING IN THIRD SPACE ENDOSCOPY: A RANDOMIZED CONTROLLED TRIAL

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Introduction

Third-space endoscopy (TSE) is standard for treating neoplastic and motility disorders but is limited by intra-procedural bleeding. Vessel pre-sealing using electrocautery in an underwater setting may mitigate this, improving procedural safety and efficiency.

Aims & Methods

We conducted a randomized controlled trial (NCT05804266) comparing underwater (saline immersion) vs conventional CO₂-based coagulation during TSE procedures (ESD and POEM). Patients were randomized 1:1. The same electrosurgical settings (SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD) and instruments (VIO 3 and HybridKnife T-type, Erbe Elektromedizin GmbH, Tübingen, Germany) were used across arms. In the underwater group, vessels ≥1.2 mm were coagulated under saline immersion to enable pre-sealing; smaller vessels were treated conventionally. In the control group, all vessels were treated under CO₂, with vessel isolation when needed. Primary endpoint was the rate of intra-procedural bleeding requiring further hemostatic treatment (knife tip, coagulation forceps) of pre-sealed vessels. Secondary outcomes included other adverse events (ie delayed bleeding).

Results

Among 70 patients (37 underwater, 33 CO₂, no significant demographic difference including history of antiplatelet/anticoagulant therapy, discontinued in all patients on therapy), intra-procedural bleeding requiring hemostasis of pre-sealed vessels occurred in 12/37 (32.4%) underwater group vs 25/33 (75.8%) control (RR 0.43(0.26-0.71); NNT 2.3; P<0.01). In the underwater group, no patient required coagulation forceps; all bleedings were managed with the knife. In contrast, 9/33 (27.3%) control patients required forceps (RR: 0.05 (0.00-0.78); NNT 3.76 P<0.01). One intra-procedural perforation and two post-procedural adverse events (delayed bleeding and fever) occurred in the control group; none in the underwater arm (n.s). No mortality occurred.

Conclusion

Underwater (saline immersion) vessel pre-sealing significantly reduces the risk of intraprocedural bleeding and consequently the need of hemostatic devices, suggesting a safer, cost-effective alternative to conventional coagulation in TSE.

VESSEL PRE-SEALING IN THIRD SPACE ENDOSCOPY: A RANDOMIZED CONTROLLED TRIAL

Antonio Capogreco 1, Cesare Hassan 2, Roberto de Sire 1, Ludovico Alfarone 1, Davide Massimi 2, Francesco Minini 2, Luca Brandaleone 2, Chiara Morelli 1, Maritalia Simone 1, Marco Spadaccini 3, Matteo Colombo 1, Marta Andreozzi 2, Maria Terrin 2, gianluca franchellucci 2, Alessandro Fugazza 1, Silvia Carrara 1, Roberta Maselli 3, Alessandro Repici 1

1 Humanitas Research Hospital, Rozzano, Milan, Italy, Rozzano, Italy

2 Humanitas University, Pieve Emanuele MI, Italy

3 Humanitas University, Rozzano (MI), Italy

Event

UEG Week Berlin 2025

Topics

Endoscopy Oesophagus

Submission format

Abstract

Session

Randomised controlled trials in upper GI endoscopy

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Green endoscopy: Step by step to a paper free endoscopy unit

Konstantinos Triantafyllou 1

1 Attikon University General Hospital, Athens, Greece

Event

UEG Week Berlin 2025

Topics

Nurses

Session

Green endoscopy: What makes sense?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Gastric cancer: Individualised surgical and personalised systemic treatment

Christiane Bruns 1, Aziz Zaanan 2

1 Universitätsklinikum Köln, Köln, Germany

2 Paris-Cité University, Paris, France

Event

UEG Week Berlin 2025

Session

Gastric cancer: MDT approach

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Diagnosis and treating sarcopenia in hepatic disorders

Francesca Romana Ponziani 1

1 Agostino Gemelli Hospital, Rome, Italy

Event

UEG Week Berlin 2025

Topics

Hepatobiliary

Session

What's new in complications in chronic liver disease in 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Total neoadjuvant treatment: The way forward?

Wytze Lameris 1

1 Amsterdam UMC, Amsterdam, Netherlands

Event

UEG Week Berlin 2025

Topics

Colorectal Digestive Oncology Mechanisms & Personalised Medicine

Session

Catching up with every day's practise in colorectal cancer treatment

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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IMPROVED ENDOSCOPIC VISIBILITY WITH GEL VERSUS WATER IMMERSION DURING COLORECTAL UNDERWATER EMR: A RANDOMIZED CROSSOVER TRIAL

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Introduction

Underwater endoscopic mucosal resection (UEMR) has been increasingly utilized due to its clinical benefits. However, in patients with poor bowel preparation, UEMR is limited by impaired endoscopic visualization due to luminal turbidity. Viscoclear®, a gel designed to secure endoscopic fields, has been available in Japan since 2020 and has demonstrated a 92.2% effectiveness rate in improving visibility during bleeding or inadequate bowel prep. While its usefulness during UEMR has been anticipated, clinical evidence remains limited. We conducted an image analysis study to evaluate the visibility enhancement effect of gel immersion compared to underwater.

Aims & Methods

This study was a prospective randomized crossover trial to compare the endoscopic visibility of colorectal adenomatous lesions (6-20 mm) between under-water and under-gel observation. Each lesion was observed alternately in both settings using white light imaging (WLI), blue laser imaging (BLI), and linked color imaging (LCI). Color difference (ΔE) between tumor and adjacent non-tumor areas was calculated using the Lab color space in Photoshop (Adobe Systems Inc.) to evaluate lesion margins. Based on preliminary retrospective data from our institution, a sample size of 72 was calculated (power: 0.8, one-sided α: 0.05). (jRCTs062220033)

Results

Between July 2022 and May 2024, 72 lesions were enrolled. Median tumor size was 8 mm (range: 6–18 mm). Histopathology revealed 65 adenomas (90.3%), 2 cancers (2.6%), 3 traditional serrated adenomas (4.1%), and 2 hyperplastic polyps (2.8%). Boston Bowel Preparation Scale Segment Scores (BBPS-SS) were 3 in 50 cases, 2 in 21 cases, and 1 in 1 case.
Median ΔE values in the underwater group were 10.0 (WLI), 15.7 (BLI), and 11.7 (LCI), while those in the under-gel group were 12.4 (WLI), 21.1 (BLI), and 13.1 (LCI). ΔE was significantly higher in the under-gel group than the underwater group under WLI and BLI (p = 0.01 and p < 0.01, respectively).
In subgroup analysis by BBPS-SS, under-gel observation showed significantly higher ΔE in WLI and BLI when BBPS-SS ≤2 (p = 0.03 and p < 0.01, respectively). No significant differences were seen when BBPS-SS was 3.

Conclusion

Under-gel observation improved the visibility of lesion margins under WLI and BLI compared to underwater observation, particularly in patients with suboptimal bowel preparation. Gel immersion endoscopy may therefore be a useful adjunct in difficult visualization conditions during colorectal UEMR.

IMPROVED ENDOSCOPIC VISIBILITY WITH GEL VERSUS WATER IMMERSION DURING COLORECTAL UNDERWATER EMR: A RANDOMIZED CROSSOVER TRIAL

Junki Toyosawa 1, Yasushi Yamasaki 1, Hidetaka Mizushima 1, Mikako Ishiguro 1, Takashi Yamamoto 1, Yuki Aoyama 1, Keiko Takeuchi 1, Toshihiro Inokuchi 1, Hideaki Kinugasa 1, Masahiro Takahara 1, Sakiko Hiraoka 1, Motoyuki Otsuka 1

1 Okayama University Hospital, Okayama, Japan

Event

UEG Week Berlin 2025

Topics

Colorectal Endoscopy Surgery

Submission format

Abstract

Session

Improving decision-making in colorectal lesions

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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AN IMMUNE RESPONSIVE TUMOR MICROENVIRONMENT IMPRINTS INTO PBMCS AND ALLOWS TO PREDICT PATIENT OUTCOME USING MACHINE LEARNING IN ADVANCED PANCREATIC CANCER: LESSONS FROM THE PREDICT TRIAL

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Introduction

Prognosis in advanced pancreatic ductal adenocarcinoma (aPDAC) is particularly poor. Few patients benefit from second-line chemotherapy, while most experience side effects, highlighting the need for biomarkers. The PREDICT trial examined in aPDAC patients whether first-line time-to-treatment failure (TTF1) predicts second-line treatment failure (TTF2) but found no association. In our translational study we hypothesized that the responsiveness of the tumor immune microenvironment (TiME) might determine second-line therapy outcome and examined whether treatment-naive tissue immune features are also reflected in the peripheral blood after one line of chemotherapy.

Aims & Methods

In the PREDICT trial, patients received 5-FU/LV plus nanoliposomal irinotecan second-line after gemcitabine/nab-paclitaxel (Gem-nabPac) first-line therapy. We stratified PREDICT patients by shortest vs. longest TTF2. Treatment-naive primary tumor tissues from 20 patients were analyzed by NanoString transcriptomic profiling and multiplexed immunohistochemistry to characterize differences in the TiME. Peripheral blood mononuclear cells (PBMCs) were obtained immediately before second-line therapy from 82 patients and analyzed using multiparameter flow cytometry with an automated gating procedure and gene expression profiling via RT-qPCR. A feature selection and machine learning pipeline integrated PBMC and clinical data to derive a minimal predictor for TTF2 outcome and prognosis that was validated across different treatment regimens on an independent external cohort of 30 patients with aPDAC.

Results

Treatment-naive tumors of patients in the long-TTF2 group exhibited an immune-active (“hot”) TiME with CXCR3⁺CD8⁺ cytotoxic T cell infiltration into the cancer cell compartment via CXCR3-dependant inflammatory chemokine signaling. Analysis of PBMCs obtained directly before second-line therapy showed that these immune features were sustained over one line of treatment and reflected in PBMCs. A PBMC-based machine learning model (“TTF2Pred”) identified a 7-feature immune signature that accurately distinguished long vs. short TTF2 patient groups outperforming multivariate clinical data or CA19-9 benchmark models. TTF2Pred robustness was confirmed by external validation and showed the best overall performance post-Gem-nabPac first-line treatment. Among the seven TTF2Pred features, long-TTF2 patients exhibited more circulating CXCR3⁺ activated T cells and plasmacytoid dendritic cells, while short-TTF2 patients had more circulating platelet–leukocyte (platelet-monocyte, platelet-neutrophil) aggregates and exhausted T cells.

Conclusion

PDAC patients with an immune-active, treatment-naïve TiME have a better outcome on second-line therapy, and these tissue characteristics are reflected in circulating PBMCs after one line of chemotherapy. A parsimonious circulating PBMC-based signature offers a minimally invasive predictor of second-line outcome that could inform personalized therapy.

AN IMMUNE RESPONSIVE TUMOR MICROENVIRONMENT IMPRINTS INTO PBMCS AND ALLOWS TO PREDICT PATIENT OUTCOME USING MACHINE LEARNING IN ADVANCED PANCREATIC CANCER: LESSONS FROM THE PREDICT TRIAL

Anton Lahusen 1, Manfred P. Lutz 2, Rui Fang 3, Martina Kirchner 4, Sarah Wisser 5, Klaus Kluck 4, Meinolf Karthaus 6, Andreas Schwarzer 7, Gabriele Siegler 8, Thomas J. Ettrich 1, Alexander Becher 1, Sabine Hoefling 9, Jens T. Siveke 3, Jan Budczies 4, Andrea Tannapfel 5, Albrecht Stenzinger 4, Phyllis Fung-Yi Cheung 3, Tim Eiseler 1, Thomas Seufferlein 1

1 University Hospital Ulm, Ulm, Germany

2 Caritas Klinikum Saarbrücken St. Theresia, Saarbrücken, Germany

3 University Hospital Essen, Essen, Germany

4 Heidelberg University Hospital, Heidelberg, Germany

5 Ruhr University, Bochum, Germany

6 München Klinik Harlaching and Neuperlach, München, Germany

7 Onkopraxis Probstheida, Leipzig, Germany

8 Klinikum Nürnberg Nord/Paracelsus Medizinische Privatuniversität, Nürnberg, Germany

9 CROLLL GmbH, Nürnberg, Germany

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Immunology Pancreas Surgery

Submission format

Abstract

Session

PDAC surveillance and treatment: The how's and why's

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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