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Endoscopic ultrasound-guided transluminal drainage using lumen-apposing metal stent with or without coaxial plastic stent for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial

Published:January 13, 2023DOI:https://doi.org/10.1016/j.gie.2022.12.026
Endoscopic ultrasound-guided transluminal drainage using lumen-apposing metal stent with or without coaxial plastic stent for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial
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      Abstract

      Background and Aims

      Lumen-apposing metal stents (LAMS) have proven to be effective for drainage of pancreatic walled-off necrosis (WON), although associated adverse events (AE) have been reported. Anchoring coaxial double-pigtail plastic stents (DPS) within LAMS have been proposed to prevent LAMS-related AEs, but have not been assessed in prospective studies. We aimed to evaluate the utility of such measures with a randomized controlled trial.

      Methods

      We randomly assigned consecutive patients with WON indications for drainage to endoscopic ultrasound (EUS)-guided transluminal drainage using LAMS with (A) or without (B) DPS. All LAMS were to be extracted after 3 weeks had elapsed from the index procedure with a preceding CT scan to decide whether additional steps needed to be taken, e.g., transluminal necrosectomy, or placing transluminal plastic stents in patients with incomplete resolution of WON. Main outcomes included failure of the index method, defined as necessity of re-intervention (endoscopic, percutaneous, surgical) before LAMS extraction due to LAMS-related AEs and/or clinical deterioration, AE rates, and mortality with LAMS in place. Variables were evaluated using the Mann-Whitney U test, χ2 test or Fisher's exact test as appropriate. P < .05 was considered significant.

      Results

      A total of 67 patients (37.3% females, mean age 54 ± 14.4 years) underwent LAMS with (n = 34) or without DPS (n = 33) placement in two tertiary centers. Baseline characteristics including demographics, etiology, comorbidity, and clinical presentation (sterile vs. infected necrosis) were comparable between both groups. The technical success rate in placing LAMS and DPS was 100%. The global rate of AEs was significantly lower in group A (20.7% vs. 51.5%, P = .008). Stent occlusion was the most frequently observed AE (14.7% vs. 36.3%, P = .042). Failure of the index method was lower in group A (29.4% vs. 48.5%, P = .109), however the difference did not achieve statistical significance. The same applied to the mortality rate with LAMS in place (2.9% vs. 12.1%, P = .197).

      Conclusions

      The addition of a coaxial DPS within LAMS was associated with a significantly lower global rate of AEs and stent occlusion rate in EUS-guided drainage of WON.

      Key words

      Acronyms and Abbreviations:

      AE (Adverse event), CECT (Contrast-enhanced computed tomography), DPS (Double-pigtail plastic stent), ETN (Endoscopic transluminal necrosectomy), EUS (Endoscopic ultrasound), ETD (EUS-guided transluminal drainage), LAMS (Lumen-apposing metal stents), NP (Necrotizing pancreatitis), OF (Organ failure), PP (Pancreatic pseudocyst), PS (Plastic stent), PFC ((Peri-)pancreatic fluid collection), RCT (Randomized controlled trial), WON (Walled-off necrosis)
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      Article info

      Publication history

      Accepted: December 31, 2022
      Received in revised form: December 16, 2022
      Received: October 24, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Author Contributions: P Vanek: conceptualization, study design, acquisition of data, analysis and interpretation of data, original draft preparation; P Falt – conceptualization, study design, endoscopist performing procedures in the trial, analysis and interpretation of data, critical revision of manuscript; P Vitek – endoscopist performing procedures in the trial, acquisition of data, critical revision of manuscript; V Zoundjiekpon – acquisition of data, critical revision of manuscript; M Horinkova – acquisition of data; J Zapletalova – statistical analysis; M Lovecek – surgeon performing procedures in the trial, critical revision of manuscript; O Urban – conceptualization, study design, endoscopist performing procedures in the trial, analysis and interpretation of data, critical revision of manuscript. All authors had access to study data and have reviewed and approved the final manuscript.

      Acknowledgement: Authors thank prof. Martin L. Freeman, M.D., MACG, MASGE for his expertise and substantial assistance throughout revision of the manuscript.

      Trial registration number: NCT03923686.

      Identification

      DOI: https://doi.org/10.1016/j.gie.2022.12.026

      Copyright

      © 2023 by the American Society for Gastrointestinal Endoscopy

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