Article Text

other Versions

PDF
Original article
Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial
  1. Ji Young Bang,
  2. Udayakumar Navaneethan,
  3. Muhammad K Hasan,
  4. Bryce Sutton,
  5. Robert Hawes,
  6. Shyam Varadarajulu
  1. Center for Interventional Endoscopy, Florida Hospital, Orlando, Florida, USA
  1. Correspondence to Dr Shyam Varadarajulu, Center for Interventional Endoscopy, Florida Hospital, Orlando, FL 32803, USA; svaradarajulu{at}yahoo.com

Abstract

Objective Although lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off necrosis (WON), their advantage over plastic stents is unclear. We compared efficacy of LAMS and plastic stents for WON drainage.

Design Patients with WON were randomised to endoscopic ultrasound-guided drainage using LAMS or plastic stents. Primary outcome was comparing total number of procedures to achieve treatment success defined as symptom relief in conjunction with WON resolution on CT at 6 months. Secondary outcomes were treatment success, procedure duration, clinical/stent-related adverse events, readmissions, length of hospital stay (LOS) and costs.

Results 60 patients underwent LAMS (n=31) or plastic stent (n=29) placement. There was no significant difference in total number of procedures performed (median 2 (range 2–7) LAMS vs 3 (range 2–7) plastic, p=0.192), treatment success, clinical adverse events, readmissions, LOS and overall treatment costs between cohorts. Although procedure duration was shorter (15 vs 40 min, p<0.001), stent-related adverse events (32.3% vs 6.9%, p=0.01) and procedure costs (US$12 155 vs US$6609, p<0.001) were higher with LAMS. Significant stent-related adverse events were observed ≥3 weeks postintervention in LAMS cohort. Interim audit resulted in protocol amendment where CT scan was obtained at 3 weeks postintervention followed by LAMS removal if WON had resolved. After protocol amendment, there was no significant difference in adverse events between cohorts.

Conclusion Except for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if WON has resolved.

Trial registration number NCT02685865.

  • endoscopic ultrasonography
  • pancreatic disease

Statistics from Altmetric.com

Footnotes

  • Contributors JYB: study design, endoscopist performing procedures in the trial, acquisition of data, analysis and interpretation of data, statistical analysis, drafting of manuscript, critical revision of manuscript. SV: study concept and design, endoscopist performing procedures in the trial, interpretation of data, drafting of manuscript, critical revision of manuscript. BS: cost data analysis, drafting of manuscript, critical revision of manuscript. MKH, UN, RH: endoscopists performing procedures in the trial, critical revision of manuscript.

  • 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 SV: Consultant for Olympus Medical Systems Corporation and Boston Scientific Corporation. RH: Consultant for Olympus Medical Systems Corporation and Boston Scientific Corporation.

  • Patient consent Obtained.

  • Ethics approval Institutional Review Board.

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

  • Presented at Oral presentation, Pancreas Club 2017, Chicago, Illinois, USA.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles