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Original research
EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial
  1. John Gásdal Karstensen1,2,
  2. Srdan Novovic1,2,
  3. Erik Feldager Hansen1,
  4. Annette Bojer Jensen3,
  5. Henrik Lovendahl Jorgensen2,4,
  6. Morten Laksafoss Lauritsen1,2,
  7. Mikkel Parsberg Werge1,
  8. Palle Nordblad Schmidt1
  1. 1Pancreatitis Centre East (PACE), Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
  2. 2Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  3. 3Department of Radiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
  4. 4Department of Clinical Biochemistry, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
  1. Correspondence to Dr John Gásdal Karstensen, Pancreatitis Centre East (PACE), Gastro Unit, Department of Gastroenterology and Gastrointestinal Surgery, Hvidovre Hospital, Hvidovre 2650, Denmark; john.gasdal.karstensen{at}regionh.dk

Abstract

Objective In treating pancreatic walled-off necrosis (WON), lumen-apposing metal stents (LAMS) have not proven superior to the traditional double pigtail technique (DPT). Among patients with large WON (>15 cm) and their associated substantial risk of treatment failure, the increased drainage capacity of a novel 20-mm LAMS might improve clinical outcomes. Hence, we conducted a study comparing the DPT and 20-mm LAMS in patients with large WON.

Design A single-centre, open-label, randomised, controlled superiority trial using an endoscopic step-up approach in patients with WON exceeding 15 cm in size. The primary endpoint was the number of necrosectomies needed to achieve clinical success (clinical and CT resolution), while the secondary endpoints included technical success, adverse events, length of stay and mortality.

Results Twenty-two patients were included in the DPT group and 20 in the LAMS group, with no significant differences in patient characteristics. The median size of WON was 24.1 cm (P25–P75: 19.6–31.1). The technical success rates were 100% for DPT and 95% for LAMS (p=0.48), while clinical success rates were 95.5% and 94.7%, respectively (p=1.0). The mean number of necrosectomies was 2.2 for DPT and 3.2 for LAMS (p=0.42). Five patients (12%) developed procedure-related serious adverse events (DPT=4, LAMS=1, p=0.35). The median length of stay was 43 (P25–P75: 40–67) and 58 days (P25–P75: 40–86) in the DPT and LAMS groups (p=0.71), respectively, with an overall mortality of 4.8%.

Conclusions For treating large WON, LAMS are not superior to DPT. The techniques are associated with comparable needs for necrosectomy and hospital stay, and no gross difference in adverse events.

Trial registration number NCT04057846.

  • endoscopic ultrasonography
  • acute pancreatitis

Data availability statement

Data are available on reasonable request. Relevant anonymised patient-level data are available on reasonable request.

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Data availability statement

Data are available on reasonable request. Relevant anonymised patient-level data are available on reasonable request.

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Footnotes

  • Correction notice This article has been corrected since it published Online First. The author's name, Henrik Lovendahl Jorgensen, has been corrected.

  • Contributors JGK, SN, EFH and PNS designed and planned the study. JGK, SN, EFH, MPW, HLJ, MLL, ABJ and PNS conducted the study. JGK drafted the manuscript. All authors critically revised the manuscript for important intellectual content and approved the final manuscript. The guarantor of the article is JGK.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.