Endoscopy 2025; 57(S 02): S30
DOI: 10.1055/s-0045-1805149
Abstracts | ESGE Days 2025
Oral presentation
Endoscopic Resections in the Duodenum 03/04/2025, 10:30 – 11:30 Room 124+125

First interim Results of the German 'COLD-RESECT' Study: Prospective Randomized Comparison of Resection of Large Non-Ampullary Duodenal Adenomas Using Cold vs. Hot Snare

Authors

  • M Ayoub

    1   St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany

  • S Nagl

    2   University Hospital Augsburg, Augsburg, Germany

  • C Römmele

    2   University Hospital Augsburg, Augsburg, Germany

  • A Prbost

    2   University Hospital Augsburg, Augsburg, Germany

  • T Weber

    2   University Hospital Augsburg, Augsburg, Germany

  • G Braun

    2   University Hospital Augsburg, Augsburg, Germany

  • E Schnoy

    2   University Hospital Augsburg, Augsburg, Germany

  • J Classen

    2   University Hospital Augsburg, Augsburg, Germany

  • D Albers

    3   Elisabeth hospital, Essen, Germany

  • S Belle

    4   Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany

  • P Dautel

    5   University Medical Center Hamburg-Eppendorf, Hamburg, Germany

  • R Koschny

    6   University Hospital, Department of Gastroenterology, Endoscopy Unit, Heidelberg, Germany

  • K Kouladouros

    7   Charité University Hospital, Berlin, Germany

  • A May

    8   Asklepios Paulinen Klinik Wiesbaden, Wiesbaden, Germany

  • I Steinbrück

    9   Evangelisches Diakoniekrankenhaus Freiburg, Freiburg im Breisgau, Germany

  • T von Hahn

    10   Asklepios Klinik Barmbek, Hamburg, Germany

  • T Roesch

    11   Uniklinik Hamburg, Hamburg, Germany

  • H Messmann

    2   University Hospital Augsburg, Augsburg, Germany

  • A Ebigbo

    2   University Hospital Augsburg, Augsburg, Germany
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Aims In Western countries, endoscopic mucosal resection (EMR) using diathermy current (hot snare) is typically used for the endoscopic resection of large, non-ampullary sporadic duodenal adenomas (NASDA)≥20 mm. However, the hot snare resection of NASDA is associated with a significant complication rate. An alternative could be cold snare resection, which, in retrospective analyses, has been associated with a very low complication rate. The primary goal of the Cold-Resect study is to demonstrate, in a randomized controlled trial, the superiority of cold snare resection compared to conventional hot snare resection in terms of the rate of serious complications, particularly post-procedural bleeding and perforation. The secondary goal includes the recurrence rate after 3-6 months.

Methods The Cold-Resect study is a multicenter, prospective, randomized controlled trial. NASDAs between 20 mm and 50 mm in length and occupying up to 2/3 of the circumference were resected either by conventional EMR with a hot snare or by cold snare resection, based on randomization. Peri- and post-procedural complications were systematically recorded during the hospital stay and in a follow-up phone call after 4 weeks. An endoscopic follow-up is conducted after 3-6 months to assess the recurrence rate.

Results Between 11/2022 and 11/2024, 44 patients were included at 6 endoscopic centers in Germany. Thus far, 26.8% of the estimated total sample size of 164 patients has been reached. The median adenoma size was 39.5 x 25 mm. Post-procedural bleeding occurred in 4.2% of patients in the cold group and in 10% of patients in the hot group. Perforation was observed in 0.0% of patients in both the cold and hot groups. The recurrence rate after 3-6 months was 29.1% in the cold group and 10.0% in the hot group.

Conclusions The first interim analysis of the German Cold-Resect study shows a lower post-bleeding rate with cold snare resection. On the other hand, after only 27% of the estimated sample size, a trend toward a higher recurrence rate in the cold group can already be observed. A further interim analysis will be conducted after 50% of the estimated sample size has been reached.



Publication History

Article published online:
27 March 2025

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