Endoscopic Ultrasound-guided Transluminal Drainage of Walled-off Necrosis using Naso-cystic Drain with Metal Stent versus Metal Stent Alone: A Randomized Controlled Pilot Study.

BACKGROUND AND AIMS: Endoscopic ultrasound (EUS)-guided drainage using a lumen-apposing metal stent (LAMS) has become the standard of care in managing symptomatic walled-off necrosis (WON). However, the role of nasocystic drainage (NCD) in addition to stent placement remains uncertain. We conducted a pilot study to compare outcomes of EUS-guided drainage with and without NCD in patients with WON. METHODS: In this open-label, prospective, block-randomized controlled pilot trial, forty patients with symptomatic WON undergoing EUS-guided drainage using LAMS were randomized into two groups: NCD (n=20) and non-NCD (n=20). The two groups were compared for clinical success, defined as symptomatic improvement accompanied by a reduction in the size of the WON to ≤3 cm on cross-sectional imaging, as well as for the number of necrosectomy sessions required, duration of hospitalisation, readmissions, procedure-related complications, and mortality. RESULTS: Technical success was achieved in all patients. Clinical success at day three was observed in 55% (n=11) in the NCD arm and 45% (n=9) in the non-NCD arm (P=0.527). Time to clinical success and the number of necrosectomy sessions were comparable between groups. The median hospital stay was significantly shorter in the non-NCD group (P=0.038). Readmission (P=0.093), reintervention (P=0.495), complications (P=0.072), and mortality rates (P=0.147) were similar across both groups. CONCLUSION: The addition of nasocystic drainage to EUS-guided LAMS drainage did not improve clinical outcomes in patients with WON. However, due to the small sample size and baseline imbalance, findings are exploratory and require confirmation in larger, adequately powered randomised trials.