Interobserver Agreement on “Assessment of Debris” During Endoscopic Ultrasound-guided Drainage of Walled-off Pancreatic Necrosis

Aims: Recently, larger calibre metal stents have been increasingly used, assuming higher efficacy in walled-off necrosis (WON) with higher solid debris. However, none of the trials has included WON having significant solid debris. The aim of this study was to compare plastic stents and metal stents for drainage of symptomatic WON with significant solid debris (≥20%). Patients and methods: We conducted a single-centre, open-label, noninferiority trial including 48 patients. The primary endpoint was treatment success. Secondary outcomes were technical success, total number of procedures, adverse events, duration of procedure and treatment failure. All the outcomes were assessed at 3 weeks after drainage. Patients were followed up for 3 months to assess recurrence. Result: The treatment success was 21/24 (proportion 1 i.e., p1=87.5%) and 20/24 (proportion 2 i.e., p2=83.3%) in metal stent and plastic stent group, respectively with P1/p2=1.05 (95% confidence interval of the proportion is 0.81 to 1.39). Assuming 10% non-inferiority margin, the p-value was <0.001 for non-inferiority, suggesting that plastic stents are non-inferior to metal stents. Technical success was 100%. The duration of procedure was significantly shorter in metal stent group (12.95±5.3 minutes versus 29.77±6.6 minutes, p=<0.001). The number of total procedures was comparable (2.8±1 versus 2.2±1, p=0.097). The minor adverse events were more in plastic stent arm without significant difference. Single asymptomatic recurrence was observed in metal stent arm. Conclusion: Plastic stents are not inferior to metal stents for WON drainage with significant solid debris. However, larger sample-sized studies are needed to make definite conclusions.

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Interobserver Agreement on “Assessment of Debris” During Endoscopic Ultrasound-guided Drainage of Walled-off Pancreatic Necrosis

Cited by 2 publications

References 21 publications

The timing of endoscopic necrosectomy: More questions than answers

The timing of endoscopic necrosectomy: More questions than answers

Plastic versus metal stents for transmural drainage of walled-off necrosis with significant solid debris: a randomized controlled trial

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