A novel laser-cut fully-covered metal stent with anti-reflux valve in patients with malignant distal biliary obstruction refractory to conventional covered metal stent.

BACKGROUND: Stenting against recurrent biliary obstruction (RBO) after placement of covered metal stent (CMS) for distal malignant biliary obstruction (MBO) is still challenging. This study investigated the feasibility of a novel laser-cut fully-covered metal stent with anti-reflux valve in patients with distal MBO refractory to conventional CMS.

METHODS: Patients who underwent Duckbill-type metal stent (DMS) placement between June 2019 and May 2020 were included. Early complications, causes of RBO including non-occlusion cholangitis, and time to RBO (TRBO) were evaluated. TRBO of DMS was also compared with that of previous CMS.

RESULTS: Thirty patients were included: pancreatic cancer/metastatic lymph nodes 29/1; duodenal stenosis 13. Technical and functional success were achieved in all patients. Mild cholangitis and mild pancreatitis developed in each one. Median follow-up period was 167 days (range, 23-527 days). RBO occurred in 9 patients (30%): sludge formation 4, hemobilia 1, symptomatic distal stent migration 3, and non-occlusion cholangitis 1. TRBO of DMS was significantly longer than that of previous CMS (median 224 days vs. median 120 days, p=0.0025). DMS was successfully removed in all of 6 attempted patients when re-intervention was needed.

CONCLUSIONS: DMS might be safe and effective in patients with distal MBO refractory to conventional CMS.