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Original research
Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis
  1. Lotte Boxhoorn1,2,3,
  2. Robert C Verdonk4,
  3. Marc G Besselink2,5,
  4. Marja Boermeester2,5,
  5. Thomas L Bollen6,
  6. Stefan AW Bouwense7,
  7. Vincent C Cappendijk8,
  8. Wouter L Curvers9,
  9. Cornelis H Dejong7,
  10. Sven M van Dijk2,3,5,
  11. Hendrik M van Dullemen10,
  12. Casper HJ van Eijck11,
  13. Erwin JM van Geenen12,
  14. Muhammed Hadithi13,
  15. Wouter L Hazen14,
  16. Pieter Honkoop15,
  17. Jeanin E van Hooft16,
  18. Maarten AJM Jacobs2,17,
  19. June EC Kievits1,2,
  20. Marnix PM Kop18,
  21. Eva Kouw19,
  22. Sjoerd D Kuiken20,
  23. Michiel Ledeboer21,
  24. Vincent B Nieuwenhuijs22,
  25. Lars E Perk23,
  26. Jan-Werner Poley24,
  27. Rutger Quispel25,
  28. Rogier JJ de Ridder26,
  29. Hjalmar C van Santvoort27,28,
  30. Christina J Sperna Weiland3,12,
  31. Martijn WJ Stommel29,
  32. Hester C Timmerhuis3,28,
  33. Ben J Witteman30,
  34. Devica S Umans1,2,3,
  35. Niels G Venneman31,
  36. Frank P Vleggaar32,
  37. Roy LJ van Wanrooij2,17,
  38. Marco J Bruno24,
  39. Paul Fockens1,2,
  40. Rogier P Voermans1,2
  41. The Dutch Pancreatitis Study Group
  1. 1Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands
  2. 2Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
  3. 3Department of Research and Development, Sint Antonius Hospital, Nieuwegein, The Netherlands
  4. 4Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
  5. 5Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands
  6. 6Department of Radiology, Sint Antonius Hospital, Nieuwegein, The Netherlands
  7. 7Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands
  8. 8Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands
  9. 9Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands
  10. 10Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands
  11. 11Department of Surgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands
  12. 12Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands
  13. 13Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands
  14. 14Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands
  15. 15Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands
  16. 16Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands
  17. 17Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit, Amsterdam, The Netherlands
  18. 18Department of Radiology, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands
  19. 19Department of Gastroenterology and Hepatology, Gelre Hospital, Apeldoorn, The Netherlands
  20. 20Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands
  21. 21Department of Gastroenterology and Hepatology, Deventer Hospital, Deventer, The Netherlands
  22. 22Department of Surgery, Isala Clinics, Zwolle, The Netherlands
  23. 23Department of Gastroenterology, Haaglanden Medical Center, Den Haag, The Netherlands
  24. 24Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands
  25. 25Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, The Netherlands
  26. 26Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands
  27. 27Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
  28. 28Department of Surgery, Sint Antonius Hospital, Nieuwegein, The Netherlands
  29. 29Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands
  30. 30Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands
  31. 31Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands
  32. 32Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
  1. Correspondence to Dr Rogier P Voermans, Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; r.p.voermans{at}amsterdamumc.nl

Abstract

Objective Lumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.

Design Patients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.

Results A total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention—5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference −€6348, bias-corrected and accelerated 95% CI −€26 386 to €10 121).

Conclusion Our comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.

  • endoscopy
  • acute pancreatitis

Data availability statement

Data are available on reasonable request. Request for data can be made to the corresponding author (r.p.voermans@amsterdamumc.nl) and will first be discussed during a meeting of the Dutch Pancreatitis Study Group.

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Data availability statement

Data are available on reasonable request. Request for data can be made to the corresponding author (r.p.voermans@amsterdamumc.nl) and will first be discussed during a meeting of the Dutch Pancreatitis Study Group.

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Footnotes

  • Twitter @marcbesselink

  • Collaborators The Dutch Pancreatitis Study Group.

  • Contributors This study was primarily designed by LB, RCV, MGB, JEvH, J-WP, FPV, MBo, PF and RPV, and was subsequently discussed in research meetings with all authors. The study was conducted by LB, RCV, MGB, MAB, TLB, SAWB, VCC, WC, CHD, SMvD, HMvD, CvE, E-JvG, MH, WLH, PH, JEvH, MAJMJ, JECK, MPMK, EK, SK, ML, VBN, LP, J-WP, RQ, RJdR, HCvS, CJSW, MS, HCT, BW, DSU, NGV, FV, RLJvW, MBr, PF and RPV. The data were collected and analysed by LB who also drafted the manuscript under supervision of RPV. All authors contributed to the interpretation of the data and to the draft of the manuscript. All authors have approved of the final manuscript. The guarantor of the article is RPV.

  • Funding This study was funded by Boston Scientific Corporation (grand number: ISREND00028) and Amsterdam UMC (grand number: not applicable).

  • Competing interests MGB reports grants from Intuitive, grants from Ethicon Endo-Surgery, grants from Medtronic, outside the submitted work; MBo reports grants and personal fees from Johnson & Johnson, grants and personal fees from Acelity/KCI, grants and personal fees from Bard, grants from Ipsen, grants from New Compliance, grants from Mylan, personal fees from Gore, personal fees from Smith & Newphew, outside the submitted work; MBr reports grants and personal fees from Boston Scientific, grants and personal fees from Cook Medical, grants from Pentax Medical, grants from Mylan, grants from 3M, grants from InterScope, outside the submitted work; PF reports personal fees from Cook Medical, personal fees from Olympus, personal fees from Ethicon Endo-Surgery, outside the submitted work; J-WP reports personal fees and other from Cook Endoscopy, personal fees and other from Boston Scientific, personal fees and other from Pentax Medical, outside the submitted work; E-JvG reports grants from Mylan, grants from Olympus, personal fees from MTW-Endoskopie, outside the submitted work; JEvH reports personal fees from Olympus Endoscopy, grants from Cook Medical, personal fees from Boston Scientific, personal fees from Medtronic, outside the submitted work; FV reports grants from Boston Scientific, outside the submitted work; RPV reports grants and personal fees from Boston Scientific, grants from Zambon, outside the submitted work.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or 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.

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