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Randomized Controlled Trial
. 2023 Jan;72(1):66-72.
doi: 10.1136/gutjnl-2021-325632. Epub 2022 Jun 14.

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Lotte Boxhoorn  1   2   3 , Robert C Verdonk  4 , Marc G Besselink  2   5 , Marja Boermeester  2   5 , Thomas L Bollen  6 , Stefan Aw Bouwense  7 , Vincent C Cappendijk  8 , Wouter L Curvers  9 , Cornelis H Dejong  7 , Sven M van Dijk  2   3   5 , Hendrik M van Dullemen  10 , Casper Hj van Eijck  11 , Erwin Jm van Geenen  12 , Muhammed Hadithi  13 , Wouter L Hazen  14 , Pieter Honkoop  15 , Jeanin E van Hooft  16 , Maarten Ajm Jacobs  2   17 , June Ec Kievits  1   2 , Marnix Pm Kop  18 , Eva Kouw  19 , Sjoerd D Kuiken  20 , Michiel Ledeboer  21 , Vincent B Nieuwenhuijs  22 , Lars E Perk  23 , Jan-Werner Poley  24 , Rutger Quispel  25 , Rogier Jj de Ridder  26 , Hjalmar C van Santvoort  27   28 , Christina J Sperna Weiland  3   12 , Martijn Wj Stommel  29 , Hester C Timmerhuis  3   28 , Ben J Witteman  30 , Devica S Umans  1   2   3 , Niels G Venneman  31 , Frank P Vleggaar  32 , Roy Lj van Wanrooij  2   17 , Marco J Bruno  24 , Paul Fockens  1   2 , Rogier P Voermans  33   2 ; Dutch Pancreatitis Study Group
Affiliations
Randomized Controlled Trial

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Lotte Boxhoorn et al. Gut. 2023 Jan.

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.

Keywords: acute pancreatitis; endoscopy.

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Conflict of interest statement

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.

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